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PPMI Study CRF and Assessments
For Amendment-3
TAP-PD Version 2.1
This packet contains CRFs from the Clinical Trials
Coordination Center (CTCC; PPMI Clinical Core). The CRF and assessment information in this PDF are intended to be used by researchers accessing the PPMI data sets and are
not intended for redistribution or to be used as study documents. For assessments that require a licensing fee or
permission, the most accurate and available contact information is provided.
Should you have any questions regarding these documents please
contact us using the link: http://www.ppmi-info.org/contact-us/
06-FEB-2012
PPMI CRF Table of Contents
(Click CRF Name below to link to CRF)
Schedule of Activities for: Parkinson Disease (PD) Subjects Healthy Control (HC) Subjects Subjects without Evidence of Dopaminergic Deficit (SWEDD)
CRF Name PDF Page
Data Category (web location of Data set)
Adverse Events Log 88 Medical History
Benton Judgment of Line Orientation 43 Non-motor Assessments
Clinical Diagnosis and Management Questionnaire (SWEDD) 33 Enrollment
Clinical Laboratory Assessments 73 Biospecimen
Conclusion of Study participation - TAP-PD 94 Enrollment
Conclusion of Study participation - PPMI 87 Enrollment
Concomitant Medication Log 86 Medical History
CTCC Unique ID 10 NA
Current Medical Conditions Log 85 Medical History
DaTSCAN imaging 71 Imaging
Demographics 7 Subject Characteristics
DNA Blood Sample Collection 74 Biospecimen
Epworth Sleepiness Scale 51 Non-motor Assessments
Family History (PD) 20 Subject Characteristics
Geriatric Depression Scale (GDS-15) 56 Non-motor Assessments
Hopkins Verbal Learning Test – Revised (HVLT)
41 Non-motor Assessments
Inclusion/Exclusion Criteria 11 Enrollment
Laboratory Procedures (RNA, Urine, Plasma, & Serum sample collection)
76 Biospecimen
Letter Number Sequencing 45 Non-motor Assessments
Lumbar puncture (CSF collection) 79 Biospecimen
MDS-UPDRS (including Hoehn & Yahr) 37 Motor Assessments
MDS-UPDRS Part III / Hoehn & Yahr 38 Motor Assessments
Medical History (General) 21 Medical History
Modified Schwab & England ADL 39 Motor Assessments
Montreal Cognitive Assessment (MoCA) 48 Non-motor Assessments
MRI (structural) 70 Imaging
Neurological Examination (Cranial Nerves) 27 Medical History
Neurological Examination (General) 27 Medical History
Olfactory Testing (UPSIT) 67 Non-motor Assessments
PD Features 18 Medical History
Physical Examination (General) 29 Medical History
Pregnancy Test 32 Medical History
Primary Diagnosis 19 Enrollment
QUIP 59 Non-motor Assessments
REM Sleep Behavior Questionnaire 52 Non-motor Assessments
SCOPA-AUT 62 Non-motor Assessments
Semantic Fluency 44 Non-motor Assessments
Signature Form (out of window visits) 83 Enrollment
Socio-Economics 9 Subject Characteristics
State-Trait Anxiety Inventory for Adults (STAI)
61 Non-motor Assessments
Subject Site Transfer 89 NA
Symbol Digit Modalities Test 46 Non-motor Assessments
TAP-PD OPDM assessment (Clinic visits) 93 Motor Assessments
TAP-PD OPDM Use Questionnaire 92 Motor Assessments
TAP-PD Schedule of Assessments 90 NA
TAP-PD Subject Eligibility 91 Enrollment
Telephone Visit 17 NA
Use of PD Medication and Dose 36 Medical History
Vital Signs 31 Medical History
Whole Blood Sample 75 Biospecimen
Visit Number SC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07 T08 V07 T09 V08 T10 T11 V09 T12 V10 T13 T14 V11 T15 V12 T16Visit Description Months (+30 days) -1 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60Confidential Subject Identification Log XWritten Informed Consent XScreening/Demographics 02 XSocio-Economics 04 XCTCC Unique ID 06 XInclusion/Exclusion - Parkinson disease 10 X X Telephone Follow-up 12 X X X X X X X X X X X X X X X XPD Features 14 XPrimary Diagnosis 16 X X X X X X XMedical History (General) 18 XFamily History (PD) 20 XGeneral Neurological Exam 22 X X X X X X X Xd
General Physical Exam 24 XVital Signs 26 X Xc X X X Xc X Xc X Xc X Xc X Xc Xc X XPregnancy Form 28 X X X X XUse of PD Medication 30 X X X X X X X X X X X X X X XMDS-UPDRS/Hoehn & Yahr X X X X X X X X X X X X X X X X Xd
Modified Schwab and England Activities of Daily Living 32 X X X X X X X X X X X X X X X X Xd
MDS-UPDRS (Post Dose)b 34 X X X X X XHopkins Verbal Learning Test – Revised 36 X X X X X X XBenton Judgment of Line Orientation X X X X X X XSemantic Fluency 38 X X X X X X XLetter Number Sequencing (PD) 40 X X X X X X XSymbol Digit Modalities Test 42 X X X X X X XMontreal Cognitive Assessment (MoCA) 43 X X X X X X XEpworth Sleepiness Scale 44 X X X X X X X X XREM Sleep Disorder Questionnaire 46 X X X X X X X X XGeriatric Depression Scale (GDS-15) 48 X X X X X X X X XState-Trait Anxiety Inventory for Adults X X X X X X X X X
Questionnaire for Impulsive-Compulsive Disorders 50 X X X X X X X X X
Scales for Outcome in Parkinson's Disease (SCOPA-AUT)
52 X X X X X X X X X
Olfactory Testing (UPSIT) 54 XDNA Sample 56 XLaboratory Procedures 58 Xe X Xe X Xe X Xe X Xe X Xe X Xe Xe Xe
Clinical Labs 59 X X Xi X X X X X Xd
Whole Blood Sample 78 X X X X X X X X X X X X X X XMagnetic Resonance Imaging (Structural) 60 XMagnetic Resonance Imaging (DTI)f 60 X X X X XDaTSCAN Imaging 62 X X X X XLumbar Puncture 64 X Xg X X X X X X Xh
Signature Form 66 X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X XAdverse Event Log 68 Xa Xa Xa Xa Xa Xa Xa Xa Xa Xa
Current Medical Conditions Log 70 X X X X X X X X X X X X X X X XConcomitant Medication Log 72 X X X X X X X X X X X X X X X X XConclusion of Study Participation 74 X XSubject Site Transfer Form 76
a Adverse events will be assessed at the visit and 7 days ± 3 days (phone call) following the visit.b Will be conducted 1hr post treatment for subjects on levodopa or dopamine agonists. ST = Symptomatic Therapyc Height and weight also collected. PW = Premature Withdrawald Conduct as clinically indicated - see protocol Unscheduled Visit.e Biomic urine sample also collected.f MRI DTI at selected sites only.g Not repeated if ST Visit completed prior to V02. 8/9/2011h Not repeated depending on when ST visit conducted.I Completed only if not done at Month 9.
FNL= Final
If needed
PPMI Schedule of ActivitiesPARKINSON DISEASE (PD) SUBJECTS
Unsched. Visit
Level # PW STFNL
Visit Number SC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07 T08 V07 T09 V08 T10 T11 V09 T12 V10 T13 T14 V11 T15 V12 T16Visit Description Months (+30 days) -1 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60Confidential Subject Identification Log XWritten Informed Consent XScreening/Demographics 02 XSocio-Economics 04 XCTCC Unique ID 06 XInclusion/Exclusion - Healthy Control 11 X X (review)Telephone Follow-up 12 X X X X X X X X X X X X X X X XPrimary Diagnosis 16 X X X X X X XMedical History (General) 18 XFamily History (PD) 20 XGeneral Neurological Exam 22 X X X X X X X Xd
General Physical Exam 24 XVital Signs 26 X Xc X X X Xc X Xc X Xc X Xc X Xc Xc XPregnancy Form 28 XMDS-UPDRS/Hoehn & Yahr X X X X X X X Xd
Hopkins Verbal Learning Test – Revised 36 X X X X X X XBenton Judgment of Line Orientation X X X X X X XSemantic Fluency 38 X X X X X X XLetter Number Sequencing (PD) 40 X X X X X X XSymbol Digit Modalities Test 42 X X X X X X XMontreal Cognitive Assessment (MoCA) 43 X X X X X X XEpworth Sleepiness Scale 44 X X X X X X XREM Sleep Disorder Questionnaire 46 X X X X X X XGeriatric Depression Scale (GDS-15) 48 X X X X X X XState-Trait Anxiety Inventory for Adults X X X X X X XQuestionnaire for Impulsive-Compulsive Disorders
50 X X X X X X X
Scales for Outcome in Parkinson's Disease (SCOPA-AUT) 52 X X X X X X X
Olfactory Testing (UPSIT) 54 XDNA Sample 56 XLaboratory Procedures 58 Xe X Xe X Xe X Xe X Xe X Xe X Xe Xe
Clinical Labs 59 X X Xh X X X X X Xd
Whole Blood Sample 78 X X X X X X X X X X X X X XMagnetic Resonance Imaging (Structural) 60 XMagnetic Resonance Imaging (DTI)f 60 X X Xg
DaTSCAN Imagingb 62 XLumbar Puncture 64 X X X X X X X XSignature Form 66 X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X XAdverse Event Log 68 Xa Xa Xa Xa Xa Xa Xa Xa Xa
Current Medical Conditions Log 70 X X X X X X X X X X X X X X XConcomitant Medication Log 72 X X X X X X X X X X X X X X X XConclusion of Study Participation 74 X XSubject Site Transfer Form 76
a Adverse events will be assessed at the visit and 7 days ± 3 days (phone call) following the visit.b Screening DAT image maybe conducted up to 7 days prior to BL Visit.c Height and weight also collected.d Conduct as clinically indicated - see protocol Unscheduled Visit.e Biomic urine sample also collected.f MRI DTI at selected sites only. 8/9/2011g Only if PW visit done within first 12 months and MRI not done in last 6 months.h Completed only if not done at month 9.
FNL= FinalPW = Premature Withdrawal
Unsched. Visit
If needed
PPMI Schedule of ActivitiesHEALTHY CONTROL (HC) SUBJECTS
Level # PWFNL
Visit Number ReSC T01 BL T02 V01 V02 T03 V03 V04 T04 T05 V05 T06 V06 T07Visit Description Months (+30 days) -1 0 3 6 9 12 15 18 21 24Confidential Subject Identification Log XWritten Informed Consent XScreening/Demographics 02 XInclusion/Exclusion - SWEDD 86 X X (review)Telephone Follow-up 12 X X X X X X XClinical Diagnosis and Management Questionnaire 88 X X X X X X X Medical History (General) 18 XFamily History (PD) 20 XGeneral Neurological Exam 22 X X X X Xd
General Physical Exam 24 XVital Signs 26 X Xc X X X Xc X Xc Xc X XPregnancy Form 28 X X XUse of PD Medication 30 X X X X X X X X XMDS-UPDRS/Hoehn & Yahr X X X X X X X X X X Xd
Modified Schwab and England Activities of Daily Living 32 X X X X X X X X X X Xd
MDS-UPDRS (Post Dose)b 34 X X XHopkins Verbal Learning Test – Revised 36 X X X XBenton Judgment of Line Orientation X X X XSemantic Fluency 38 X X X XLetter Number Sequencing (PD) 40 X X X XSymbol Digit Modalities Test 42 X X X XMontreal Cognitive Assessment (MoCA) 43 X X X XEpworth Sleepiness Scale 44 X X X X X XREM Sleep Disorder Questionnaire 46 X X X X X XGeriatric Depression Scale (GDS-15) 48 X X X X X XState-Trait Anxiety Inventory for Adults X X X X X XQuestionnaire for Impulsive-Compulsive Disorders 50 X X X X X XScales for Outcome in Parkinson's Disease (SCOPA-AUT) 52 X X X X X XOlfactory Testing (UPSIT) 54 XLaboratory Procedures 58 Xe X Xe X Xe X Xe Xe Xe
Clinical Labs 59 X X X X Xd
Whole Blood Sample 78 X X X X X X X X XMagnetic Resonance Imaging (Structural) 60 XMagnetic Resonance Imaging (DTI)f 60 X X X XDaTSCAN Imaging 62 X XLumbar Puncture 64 X Xg X X X Xh
Signature Form 66 X X X X X X X X X X X X X X X X X XAdverse Event Log 68 Xa Xa Xa Xa Xa Xa
Current Medical Conditions Log 70 X X X X X X X X X XConcomitant Medication Log 72 X X X X X X X X X X XConclusion of Study Participation 74 X XSubject Site Transfer Form 76a Adverse events will be assessed at the visit and 7 days ± 3 days (phone call) following the visit.b Will be conducted 1hr post treatment for subjects on levodopa or dopamine agonists. ST = Symptomatic Therapyc Height and weight also collected. PW = Premature Withdrawald Conduct as clinically indicated - see protocol Unscheduled Visit.e Biomic urine sample also collected.f MRI DTI at selected sites only.g Not repeated if ST Visit completed prior to V02. 8/9/2011h Not repeated depending on when ST visit is conducted.
If neededReSC = Re-Screen
FNL = Final
PPMI Schedule of ActivitiesSWEDD SUBJECTS
Unsched. VisitLevel # PW STFNL
PPMI
SCREENING/DEMOGRAPHICS
SUBJECT ID SITE NO
Copyright © 2007 University of Rochester. All Rights Reserved. (11/1/10) 8/9/11
1 3 2 0 2
Page 1 of 2
Complete one form for each subject who has signed consent and is potentially eligible to participate in the study.
2. Gender (0 = Female of child bearing potential, 1 = Female of non-child bearing potential, 2 = Male)
Women who are surgically sterile (hysterectomy or tubal ligation) or post-menopausal (last menstruation was 1 year or more prior to Screening Visit) are considered to be of non-child- bearing potential.
2.
3. Do you identify your ethnicity as being Hispanic or Latino (Spanish origin)? (0 = No, 1 = Yes, 2 = Unknown or not reported)
3.
4.1 Do you identify yourself as being American Indian or Alaska Native? (0 = No, 1 = Yes, 2 = Unknown or not reported)
4.1
4.2 Do you identify yourself as being Asian? (0 = No, 1 = Yes, 2 = Unknown or not reported)
4.2
4.3 Do you identify yourself as being Black or African American? (0 = No, 1 = Yes, 2 = Unknown or not reported)
4.3
4.4 Do you identify yourself as being Native Hawaiian or Other Pacifi c Islander? (0 = No, 1 = Yes, 2 = Unknown or not reported)
4.4
4.5 Do you identify yourself as being White? (0 = No, 1 = Yes, 2 = Unknown or not reported)
4.5
5.
MM DD YYYY
B.
MM DD YYYY
1.
MM DD YYYY
A. Check box if subject has signed consent
5. Projected Enrollment Date:
B. Date informed consent was signed:
1. Date of birth:
4.6 Do you identify yourself with a race category not specifi ed on this form? (0 = No, 1 = Yes, 2 = Unknown or not reported) If Yes, please specify: ______________________
4.6
C. Indicate the enrollment category for this subject: (1 = Parkinson disease, 2 = Healthy Control, 3 = SWEDD)
C.
ETHNICITY
RACE
PPMI
SCREENING/DEMOGRAPHICS
SUBJECT ID SITE NO
Copyright © 2007 University of Rochester. All Rights Reserved. (11/1/10) 8/9/11
1 3 2 0 2
Page 2 of 2
9. Comments:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
7b. Reason for declining: 01 = Confi dentiality issues 07 = Physician advised declining 08 = Enrolled in other study 03 = Protocol too restrictive 09 = Not interested (specify in comments) 04 = Protocol too time intensive 05 = Travel requirements 11 = Risks of Protocol 06 = Family advised declining 12 = Did not agree to lumbar puncture 99 = Other (specify in comments)
7b.
8b. Reason for exclusion: 01 = Exclusionary medication 08 = Enrolled in other study 02 = Other medical, psychiatric, or surgical condition 03 = Disease too advanced 04 = Dx uncertain 06 = Did not meet other inclusion criteria (specify in comments) 12 = Abnormal Safety Labs 13 = SPECT Scan 99 = Other (specify in comments)
8b.
6. Referral Source: 01 = Site personnel 30 = Advocacy Organization 02 = PCP 31 = Support Group 80 = 1-800 Call center 04 = Family or Friend 58 = Clinicaltrials.gov 10 = Newspaper/ 59 = PDtrials.org Magazine Article 11 = Newspaper/ 60 = Specialist Magazine Ad 14 = Radio/TV Ad 99 = Other (specify in comments) 15 = Radio/TV Story 50 = Study Website 16 = Online News/ Blog/Other 17 = Out of Home Ad 53 = Site Website 71 = MJFF Communication 18 = Event 54 = Study Web Ad 72 = Another PD Subject
6.
7a. Declined
6a. If referred by a medical professional (02, 60), provide name:
8a. Excluded
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SOCIO-ECONOMICS
SUBJECT ID VISIT NO
Copyright © 2006 University of Rochester. All Rights Reserved. (6/26/09) 5/6/10
1 3 2 0 4
Page 1 of 1
1. Subject Education (number of years) 1.
4. Handedness (1 = Right, 2 = Left, 3 = Mixed) 4.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
CTCC UNIQUE ID
SUBJECT ID VISIT NO
Copyright © 2006 University of Rochester. All Rights Reserved. (9/19/08) 5/6/10
1 3 2 0 6
Page 1 of 1
1. CTCC 9 digit Unique ID: If you have previously generated a Unique ID for this subject and have it on fi le, please enter it from your records. If you have not yet generated a Unique ID for this subject, please go to the following website to do so: https://www.ctcc.rochester.edu/uniqueid
If you have previously generated a Unique ID for this subject, and do not have it on fi le, you can go to the website to reconstruct it. Please note - you will need to enter the information exactly as it was entered before to recreate the same Unique ID.
1. - -
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
INCLUSION/EXCLUSION - PARKINSON DISEASE (Amend 3)
SUBJECT ID
Copyright © 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/11
1 3 2 1 0
VISIT NO
Page 1 of 2
SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes)
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes)
1. Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
2. A diagnosis of Parkinson disease for 2 years or less at Screening.
3. Hoehn and Yahr Stage I or II at Baseline.
4. Not expected to require PD medication within at least 6 months from Baseline.
5. Male or female age 30 years or older at time of PD diagnosis.
6. Confi rmation from imaging core that screening dopamine transporter SPECT scan is consistent with dopamine transporter defi cit.
7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
1. Atypical PD syndromes due to either drugs (e.g., metoclopramide, fl unarizine, neuroleptics) or metabolic disorders (e.g., Wilson’s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
2. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, (e.g. selegiline, rasagiline) amantadine or other PD medication.
1.
2.
3.
4.
5.
6.
7.
8.
1.
2.
To be ELIGIBLE for study participation ALL answers to items 1-8 must be 1 = Yes and item 9 must be 1 = Yes if female of child bearing potential
9. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Women of childbearing potential must have a negative urine pregnancy test at the Screening visit. Urine pregnancy screening is not required for women who are surgically sterile or post-menopausal (last menstruation greater than or equal to 12 months prior to Screening).
9.
PPMI
INCLUSION/EXCLUSION - PARKINSON DISEASE (Amend 3)
SUBJECT ID
Copyright © 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/11
1 3 2 1 0
VISIT NO
Page 2 of 2
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) Continued
To be ELIGIBLE for study participation ALL answers to items 1-11 must be 0 = No
To discuss questionable subject eligibility, call the CTCC Project Manager.
PROTOCOL DEVIATION CODE
6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically signifi cant coagulopathy or thrombocytopenia.
9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
10. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
11. Previously obtained MRI scan with evidence of clinically signifi cant neurological disorder (in the opinion of the Investigator).
6.
7.
8.
9.
10.
11.
3. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline.
4. Has taken levopdopa or dopamine agonists prior to Baseline for more than a total of 60 days.
5. A clinical diagnosis of dementia as determined by the investigator.
3.
4.
5.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
INCLUSION/EXCLUSION - HEALTHY CONTROL (Amend 2)
SUBJECT ID
Copyright © 2006 University of Rochester. All Rights Reserved. (2/25/10) 7/8/11
1 3 2 1 1
VISIT NO
Page 1 of 2
SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes)
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes)
10. Male or female age 30 years or older at Screening.
6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically signifi cant coagulopathy or thrombocytopenia.
10.
6.
7.
7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
9. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit. Urine pregnancy screening is not required for women who are surgically sterile or post-menopausal (last menstruation greater than or equal to 12 months prior to Screening).
7.
8.
9.
8.
To be ELIGIBLE for study participation ALL answers to items 7, 8 and 10 must be 1 = Yes, and item 9 must be 1 = Yes if female of child bearing potential
9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
10. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
9.
10.
PPMI
INCLUSION/EXCLUSION - HEALTHY CONTROL (Amend 2)
SUBJECT ID
Copyright © 2006 University of Rochester. All Rights Reserved. (2/25/10) 7/8/11
1 3 2 1 1
VISIT NO
Page 2 of 2
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) Continued
To be ELIGIBLE for study participation ALL answers to items 6-15 must be 0 = No
To discuss questionable subject eligibility, call the CTCC Project Manager.
PROTOCOL DEVIATION CODE
13. Current or active clinically signifi cant neurological disorder (in the opinion of the Investigator).
14. First degree relative with idiopathic PD (parent, sibling, child).
15. MoCA score less than or equal to 26.
13.
14.
15.
11. Previously obtained MRI scan with evidence of clinically signifi cant neurological disorder (in the opinion of the Investigator).
11.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
INCLUSION/EXCLUSION - SWEDD (Amend 3)
SUBJECT ID
Copyright © 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/11
1 3 2 8 6
VISIT NO
Page 1 of 2
SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes)
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes)
1. Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
2. A diagnosis of Parkinson disease for 2 years or less at Screening.
3. Hoehn and Yahr Stage I or II at Baseline.
4. Not expected to require PD medication within at least 6 months from Baseline.
5. Male or female age 30 years or older at time of PD diagnosis.
7. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
8. Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
1. Atypical PD syndromes due to either drugs (e.g., metoclopramide, fl unarizine, neuroleptics) or metabolic disorders (e.g., Wilson’s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
2. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, (e.g. selegiline, rasagiline) amantadine or other PD medication.
1.
2.
3.
4.
5.
7.
8.
1.
2.
To be ELIGIBLE for study participation ALL answers to items 1-5 , 7, 8 and 11 must be 1 = Yes and item 9 must be 1 = Yes if female of child bearing potential
9. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Women of childbearing potential must have a negative urine pregnancy test at the Screening visit. Urine pregnancy screening is not required for women who are surgically sterile or post-menopausal (last menstruation greater than or equal to 12 months prior to Screening).
9.
11. Confi rmation from imaging core that screening dopamine transporter SPECT scan is consistent with no dopamine transporter defi cit.
11.
PPMI
INCLUSION/EXCLUSION - SWEDD (Amend 3)
SUBJECT ID
Copyright © 2006 University of Rochester. All Rights Reserved. (2/25/10) 8/9/11
1 3 2 8 6
VISIT NO
Page 2 of 2
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes) Continued
To be ELIGIBLE for study participation ALL answers to items 1-11 must be 0 = No
To discuss questionable subject eligibility, call the CTCC Project Manager.
PROTOCOL DEVIATION CODE
6. Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
7. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
8. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically signifi cant coagulopathy or thrombocytopenia.
9. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
10. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
11. Previously obtained MRI scan with evidence of clinically signifi cant neurological disorder (in the opinion of the Investigator).
6.
7.
8.
9.
10.
11.
3. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline.
4. Has taken levopdopa or dopamine agonists prior to Baseline for more than a total of 60 days.
5. A clinical diagnosis of dementia as determined by the investigator.
3.
4.
5.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
TELEPHONE FOLLOW-UP
SUBJECT ID VISIT NO T
Copyright © 2008 University of Rochester. All Rights Reserved.
1 3 2 1 2
Page 1 of 1 2/16/11
1.
1a.
1. Was contact made during this telephone call? (0 = No, 1 = Yes)
If new contact information obtained for the subject (e.g., change of phone number or address) document the new contact information in the subject’s study record and Confi dential Subject Identifi cation Log.
During the telephone contact:
Review and record concomitant medications•
Review and record adverse events •
1a. If No (0), please indicate the reason: 1 = phone disconnected 2 = multiple messages left on answering machine were not returned 3 = subject moved - unable to locate
5 = other (specify)________________________
INSTRUCTIONS: To be used for Interim Telephone call to subject.
2. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
PD FEATURES
SUBJECT ID VISIT NO
Copyright © 2006 University of Rochester. All Rights Reserved. (10/17/07) 5/6/10
1 3 2 1 4
Page 1 of 1
1. Date of fi rst symptom onset per the subject:
2a. Date of Parkinson’s disease diagnosis: (Leave blank if patient has a diagnosis other than PD.)
2a.
MM DD YYYY
2b. 1 = Actual (ACT), 2 = Day Estimated (Day), 3 = Mon/Day Est. (MD), 4 = Month Est. (Mon)
2b.
3. Were the following symptoms present at the time of diagnosis? (0 = No, 1 = Yes, U = Unknown)
3a. Resting Tremor 3a.
3b. Rigidity 3b.
3c. Bradykinesia 3c.
3d. Postural instability 3d.
3e. Other, specify: ______________________________________ 3e.
4. Side predominantly affected at onset (1 = Left, 2 = Right, 3 = Symmetric) 4.
1.
MM YYYY
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
PRIMARY DIAGNOSIS
SUBJECT ID VISIT NO
Copyright © 2006 University of Rochester. All Rights Reserved. (10/17/07) 5/6/10
1 3 2 1 6
Page 1 of 1
2. Most likely primary diagnosis:
01 = Idiopathic PD
02 = Alzheimer’s disease
03 = Chromosome-17 frontotemporal dementia
04 = Corticobasal degeneration
05 = Dementia with Lewy bodies
06 = Dopa-responsive dystonia
07 = Essential tremor
08 = Hemiparkinson/hemiatrophy syndrome
09 = Juvenile autosomal recessive parkinsonism
10 = Motor neuron disease with parkinsonism
11 = Multiple system atrophy
12 = Neuroleptic-induced parkinsonism
13 = Normal pressure hydrocephalus
14 = Progressive supranuclear palsy
15 = Psychogenic illness
16 = Vascular parkinsonism
17 = No PD nor other neurological disorder
18 = Spinocerebellar Ataxia (SCA)
97 = Other neurological disorder(s) (specify)_________________________________
2.
STAFF CODE
Examiner
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIFAMILY HISTORY (PD)
SUBJECT ID VISIT NO
Copyright © 2005 PD-DOC and the NIEHS/Parkinson Institute Working Group on Environmental Risk Questionnaires.
(10/16/07) 1/26/11
1 3 2 2 0
Page 1 of 1
NUMBER of FAMILY MEMBERS
1. Biological Mother 1.2
2. Biological Father 2.2
3. Full Siblings 3.2
4. Half Siblings 4.2
5. Maternal Grandparents 5.2
6. Paternal Grandparents 6.2
7. Maternal Aunts and Uncles 7.2
8. Paternal Aunts and Uncles 8.2
NUMBER with PD or PARKINSONISM
1.1 1
2.1 1
3.1
4.1
5.1 2
6.1 2
7.1
8.1
9. Children 9.2 9.1
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIMEDICAL HISTORY (GENERAL)
SUBJECT ID
Copyright © 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 1 of 6
1 3 2 1 8
VISIT NO
NOTE: This form starts with question 1d.
1. Has the subject ever had a signifi cant disorder, disease or surgery of the following systems?
CATEGORIES
Enter all signifi cant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in ‘Additional Information’ category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1
= A
ctiv
e2
= R
esol
ved
Year of Diagnosis
1d.
Dermatological
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1e.
Ophthalmological
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1f.
ENT
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
PPMIMEDICAL HISTORY (GENERAL)
SUBJECT ID
Copyright © 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 2 of 6
1 3 2 1 8
VISIT NO
CATEGORIES
Enter all signifi cant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in ‘Additional Information’ category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1
= A
ctiv
e2
= R
esol
ved
Year of Diagnosis
1g.
Pulmonary
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1h.
Cardiovascular
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1i.
Gastrointestinal
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
PPMIMEDICAL HISTORY (GENERAL)
SUBJECT ID
Copyright © 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 3 of 6
1 3 2 1 8
VISIT NO
CATEGORIES
Enter all signifi cant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in ‘Additional Information’ category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1
= A
ctiv
e2
= R
esol
ved
Year of Diagnosis
1j.
Hepatobiliary
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1k.
Renal
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1l.
Gynecologic/Urologic
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
PPMIMEDICAL HISTORY (GENERAL)
SUBJECT ID
Copyright © 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 4 of 6
1 3 2 1 8
VISIT NO
CATEGORIES
Enter all signifi cant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in ‘Additional Information’ category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1
= A
ctiv
e2
= R
esol
ved
Year of Diagnosis
1m.
Musculoskeletal
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1n.
Metabolic/Endocrine
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1o.
Hemato/Lymphatic
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
PPMIMEDICAL HISTORY (GENERAL)
SUBJECT ID
Copyright © 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 5 of 6
1 3 2 1 8
VISIT NO
CATEGORIES
Enter all signifi cant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in ‘Additional Information’ category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1
= A
ctiv
e2
= R
esol
ved
Year of Diagnosis
1p.
Neurologic(other than disease under study)
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1q.
Psychiatric
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
1r.
Allergy/ImmunologicPlease note drug allergies
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
PPMIMEDICAL HISTORY (GENERAL)
SUBJECT ID
Copyright © 2002 University of Rochester. All Rights Reserved. (4/24/08) 5/6/10 Page 6 of 6
1 3 2 1 8
VISIT NO
CATEGORIES
Enter all signifi cant medical history items, including history from birth to present. Specify disorder/diagnosis and onset. For surgeries, specify reason/diagnosis. Use only one line per description. If more than 4 items, enter in ‘Additional Information’ category and indicate which category the condition falls under. DO NOT ABBREVIATE. 1
= A
ctiv
e2
= R
esol
ved
Year of Diagnosis
1s.
Other
History?
(0 = None, 1 = Yes)
1.
2.
3.
4.
Additional InformationIf there are more than 4 medical history items per category, enter in ‘Additional information’ category below. Indicate which category the condition falls under (e.g., 1a, 1b, etc.). DO NOT ABBREVIATE.
Category
A.
B.
C.
D.
E.
F.
G.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
GENERAL NEUROLOGICAL EXAM
SUBJECT ID VISIT NO
Copyright © 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10
1 3 2 2 2
Page 1 of 2
1a. 1a. I
Cranial Nerves0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test
1b. 1b. II
1c. 1c. III, IV, VI
1d. 1d. V
1e. 1e. VII
1f. 1f. VIII
1g. 1g. IX, X
1h. 1h. XI
1i. 1i. XII
Motor System2. Muscle Strength 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test
2a. 2a. RIGHT ARM
2b. 2b. LEFT ARM
2c. 2c. RIGHT LEG
2d. 2d. LEFT LEG
PPMI
GENERAL NEUROLOGICAL EXAM
SUBJECT ID VISIT NO
Copyright © 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10
1 3 2 2 2
Page 2 of 2
3. Coordination 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test Finger-to-nose
3a. 3a. RIGHT HAND
3b. 3b. LEFT HAND
3c. 3c. RIGHT LEG
3d. 3d. LEFT LEG
Heel-to-shin
Sensory4. Sensation (pain, light touch, position, vibration) 0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test
4a. 4a. RIGHT ARM
4b. 4b. LEFT ARM
4c. 4c. RIGHT LEG
4d. 4d. LEFT LEG
Refl exes5. Muscle Stretch Refl exes 0 = Absent, 1 = Hypoactive, 2 = Normal, 3 = Hyperactive, no clonus, 4 = Hyperactive, clonus, 5 = Not tested, 6 = Unable to test If response is 5 or 6, describe briefl y.
5a. 5a. RIGHT ARM
5b. 5b. LEFT ARM
5c. 5c. RIGHT LEG
5d. 5d. LEFT LEG
6. Plantar Response 0 = Flexor, 1 = Extensor, 2 = Indeterminate, 3 = Not tested, 4 = Unable to test If response is 3 or 4, describe briefl y.
6a. 6a. RIGHT
6b. 6b. LEFT
STAFF CODE
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
GENERAL PHYSICAL EXAM
SUBJECT ID VISIT NO
Copyright © 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10
1 3 2 2 4
Page 1 of 2
1.
ORGAN SYSTEM ABNORMALITIES BY EXAMINATIONUse the following Key for items 1-11:0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test
1. Skin _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
2. 2. Head/Neck/Lymphatic _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
3. 3. Eyes _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
4. 4. Ears/Nose/Throat _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
5. 5. Lungs _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
PPMI
GENERAL PHYSICAL EXAM
SUBJECT ID VISIT NO
Copyright © 2002 University of Rochester. All Rights Reserved. (10/16/07) 5/6/10
1 3 2 2 4
Page 2 of 2
6.
ORGAN SYSTEM ABNORMALITIES BY EXAMINATIONUse the following Key for items 1-11:0 = Normal, 1 = Abnormal (If abnormal, describe briefl y), 2 = Not tested, 3 = Unable to test6. Cardiovascular (including peripheral vascular) _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
7. 7. Abdomen _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
8. 8. Musculoskeletal _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
9. 9. Neurological _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
10. 10. Psychiatric _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
11. 11. Other (Specify location and describe.) _______________________________________________________________
_______________________________________________________________
_______________________________________________________________
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
VITAL SIGNS
SUBJECT ID
Copyright © 2004 University of Rochester. All Rights Reserved. (10/17/07) 5/6/10
1 3 2 2 6
Page 1 of 1
11. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
1. Weight (in Kilograms) - Baseline and Annual only 1. .
2. Height (in Centimeters) - Baseline and Annual only 2.
3. Temperature (in Celsius) 3. .
4. Arm used to measure blood pressure? (1 = Right arm, 2 = Left arm) 4.
5. Supine blood pressure: systolic/diastolic (mmHg) (to be taken after subject has been supine for 1-3 minutes)
5.
6. Supine heart rate (beats per minute) (to be taken after subject has been supine for 1-3 minutes)
6.
9. Standing blood pressure: systolic/diastolic (mmHg) (to be taken after subject has been standing for 1-3 minutes)
9.
10. Standing heart rate (beats per minute) (to be taken after subject has been standing for 1-3 minutes)
10.
VISIT NO
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
PREGNANCY FORM
SUBJECT ID VISIT NO
Copyright © 2004 University of Rochester. All Rights Reserved. (4/24/09)x 6/16/11
1 3 2 2 8
Page 1 of 1
1. 1. If female, was pregancy test performed? (0 = No, 1 = Yes) If No, specify in comments.
1a.
1b.
1a. If the response to question 1 is Yes, is the subject pregnant? (0 = No, 1 = Yes)
1b. Was the urine pregnancy test result confi rmed prior to injection for SPECT scan?
(0 = No, 1 = Yes, 2 = Not Applicable) If No, specify in comments.
2. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
NOTE: If pregnant, consult protocol.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
CLINICAL DIAGNOSIS AND MANAGEMENT QUESTIONNAIRE
SUBJECT ID
Copyright © 2011 University of Rochester. All Rights Reserved. 8/9/11
1 3 2 8 8
VISIT NO
Page 1 of 2
1. To what degree are you confi dent that this person has motor signs consistent with a parkinsonian syndrome (PS) (any condition in which there is neurodegeneration of dopaminergic cells in the substantia nigra)?
1 = Motor abnormalities that are likely signs of PS (90-100%) 2 = Motor abnormalities that may be signs of PS (50-89%) 3 = Non-specifi c motor abnormalities (10-49%) 4 = No evidence of parkinsonian motor signs (0-9%)
1.
2. Indicate the following signs on examination that you believe are related to a PS (any condition in which there is neurodegeneration of dopaminergic cells in the substantia nigra). (0 = No, 1 = Yes)
2a. No motor signs consistent with PS 2b. Rest tremor 2c. Rigidity 2d. Bradykinesia 2e. Gait disturbances 2f. Other (specify)___________________________________
2a.
Disorders expected to have a dopamine transporter defi cit.
01 = Idiopathic PD 11 = Multiple system atrophy 04 = Corticobasal ganglionic degeneration 14 = Progressive supranuclear palsy 05 = Dementia with Lewy bodies 08 = Hemiparkinsonism/hemiatrophy syndrome
3. Indicate the current most likely clinical diagnosis from one of the categories listed below (choose one):
2b.
2c.
2d.
2e.
2f.
Disorders expected to have no dopamine transporter defi cit.
02 = Alzheimer disease 13 = Normal pressure hydrocephalus 03 = Chromosome 17 frontotemporal dementia 15 = Psychogenic illness 06 = Dopa-responsive dystonia 16 = Vascular parkinsonism 07 = Essential tremor 17 = No PD nor other neurological disorder 09 = Juvenile autosomal recessive parkinsonism 18 = Spinocerebellar Ataxia (SCA) 10 = Motor neuron disease with parkinsonism 12 = Neuroleptic-induced parkinsonism 97 = Other neurological disorder(s) (specify)_______________________________
3.
PPMI
CLINICAL DIAGNOSIS AND MANAGEMENT QUESTIONNAIRE
SUBJECT ID
Copyright © 2011 University of Rochester. All Rights Reserved. 8/9/11
1 3 2 8 8
VISIT NO
Page 2 of 2
4. Has there been a change in the clinical diagnosis of this subject since the last visit? (0 = No, 1 = Yes) If Yes (1) to question 4, indicate all factors that have been most infl uential in your current diagnosis: (0 = No, 1 = Yes)
4a. Dopamine transporter imaging information
4b. Clinical signs
4c. Response/lack of response to PD medication
4d. Natural history of condition (i.e. rapid progression, lack of progression)
4e. Other (specify)______________________________________________
4a.
4.
4b.
4c.
4d.
4e.
5. Has there been a change in the clinical management of this subject since the last visit? (0 = No, 1 = Yes)
5.
6. Current management for this subject includes: (0 = No, 1 = Yes)
6a. Management aimed at treating symptoms of PD, including dopamine replacement therapy, anticholinergics, MAO-B inhibitor
6b. Enrolled in a treatment trial for PD
6c. Management aimed at treating a condition other than PD or PS not associated with a dopamine transporter defi cit
6d. Additional diagnostic testing
6e. No treatment necessary
6a.
7. Has the subject seen another neurologist since the last visit? (0 = No, 1 = Yes)
7.
7a. If yes, what is that neurologist’s working diagnosis? (specify) _________________________
6b.
6c.
6d.
6e.
MOTOR ASSESSMENTS/ MDS‐UPDRS
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
USE OF PD MEDICATION
SUBJECT ID
Copyright © 2010 Parkinson Study Group. All Rights Reserved.
1 3 2 3 0
VISIT NO
Page 1 of 15/6/10
1. Is the subject on medication for treating the symptoms of Parkinson disease? (0 = No, 1 = Yes)
2. If yes, what is the subject taking: (check all that apply)
Levodopa
Dopamine Agonist
Other
3. Was the full MDS-UPDRS assessed at this visit? (0 = No, 1 = Yes)
1.
3.
4. Date of most recent PD medication dosing: 4.
MM DD YYYY
5. Time of most recent PD medication dosing prior to MDS-UPDRS being assessed: (24-hour clock)
6. Time that the full MDS-UPDRS was administered: (24-hour clock)
5. :
6. :
NOTE: At month 12 and subsequent annual follow-up visits, subjects taking levodopa or dopamine agonist will have PD medication dosing in clinic, followed by a repeat motor exam one hour after dosing (complete MDS-UPDRS Post Dose).
MDS‐UPDRS &
Hoehn & Yahr MDS‐UPDRS Permissions Permission is required to use the MDS‐developed Rating Scales (with the exception of personal/individual use). Reproduction, translation, modification, sale, or distribution of any portion of the MDS Rating Scales is strictly prohibited. MDS Rating Scales may not be incorporated into clinical trials, training or certification programs or materials, software programs, or otherwise except through use of the Permissions Request Form and payment of applicable fees.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
MDS-UPDRS (POST DOSE)
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 5/6/10
1 3 2 3 4
Page 1 of 1
A. Time of PD medication dosing in clinic: (24-hour clock)
B. Time Part III and Hoehn & Yahr administered:
A. :
B. :
3.1 Speech 3.10 Gait
3.3d Rigidity - RLE 3.15a Postural tremor - Right hand
3.2 Facial expression 3.11 Freezing of gait
3.3e Rigidity - LLE 3.15b Postural tremor - Left hand
3.3a Rigidity - Neck 3.12 Postural stability
3.4a Finger Tapping Right Hand 3.16a Kinetic tremor - Right hand
3.5b Hand movements - Left Hand 3.17b Rest tremor amplitude - LUE
3.3b Rigidity - RUE 3.13 Posture
3.4b Finger Tapping Left Hand 3.16b Kinetic tremor - Left hand
3.6a Pronation - Supination Movements - Right Hand 3.17c Rest tremor amplitude - RLE
3.7a Toe tapping - Right foot 3.17e Rest tremor amplitude - Lip/jaw
3.3c Rigidity - LUE 3.14 Global spontaneity of movement
3.5a Hand movements - Right Hand 3.17a Rest tremor amplitude - RUE
3.6b Pronation - Supination Movements - Left Hand 3.17d Rest tremor amplitude - LLE
3.7b Toe tapping - Left foot
3.8a Leg agility - Right leg
3.8b Leg agility - Left leg
3.9 Arising from chair
3.18 Constancy of rest
3.19 Were dyskinesias present
3.20 Did these movements interfere with ratings
3.21 Hoehn and Yahr Stage
No Yes
No Yes
STAFF CODEExaminer
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
MODIFIED SCHWAB & ENGLAND ACTIVITIES OF DAILY LIVING
SUBJECT ID VISIT NO
(1/25/08) 5/6/10
1 3 2 3 2
Page 1 of 1Fahn S, Elton RL, Members of the UPDRS Development Committee. The Unifi ed Parkinson’s Disease Rating Scale. In Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent developments in Parkinson’s disease, vol 2. Florham Park, NJ: Macmillan Health Care Information, 1987:153-163, 293-304
100% Completely independent. Able to do all chores without slowness, diffi culty or impairment. Essentially normal. Unaware of any diffi culty.
90% Completely independent. Able to do all chores with some degree of slowness, diffi culty and impairment. Might take twice as long. Beginning to be aware of diffi culty.
80% Completely independent in most chores. Takes twice as long. Conscious of diffi culty and slowness.
70% Not completely independent. More diffi culty with some chores. Three to four times as long in some. Must spend a large part of the day with chores.
60% Some dependency. Can do most chores, but exceedingly slowly and with much effort. Errors; some impossible.
50% More dependent. Help with half, slower, etc. Diffi culty with everything.
40% Very dependent. Can assist with all chores but few alone.
30% With effort, now and then does a few chores alone or begins alone. Much help needed.
20% Nothing alone. Can be a slight help with some chores. Severe invalid.
10% Totally dependent, helpless. Complete invalid.
0% Vegetative functions such as swallowing, bladder, and bowel functions are not functioning. Bedridden.
Consensus rating(Investigator, patient, other sources)
STAFF CODE
Examiner
1.
NON – MOTOR ASSESSMENTS
HOPKINS VERBAL LEARNING TEST REVISED (HVLT)
Hopkins Verbal Learning Test Permissions The Hopkins Verbal Learning Test must be purchased from PAR, Inc. (http://www4.parinc.com).
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
HOPKINS VERBAL LEARNING TEST - REVISED
SUBJECT ID VISIT NO
5/6/10
1 3 2 3 6
“Adapted and reproduced by special permission of the Publisher, Psychological Assessment Resources, Inc., 16204 North Florida Avenue, Lutz, Florida 33549, from the Hopkins Verbal Learning Test-Revised by Jason Brandt, PhD and Ralph H.B. Benedict, PhD, Copyright 1991, 1998, 2001 by PAR, Inc. Further reproduction is prohibited without permission from PAR, Inc.”
(10/16/07) Page 1 of 1
1. 1
1. 2
1. 3
1. 4
1. 5
1. 6
1. 7
1.1 Immediate Recall Trial 1 (# correct)
1.2 Immediate Recall Trial 2 (# correct)
1.3 Immediate Recall Trial 3 (# correct)
1.4 Delayed Recall Trial 4 (# correct after 20 minutes delay)
1.5 Delayed recognition - Total # of true - positive responses (“hits”)
1.6 Delayed recognition - # of related false - positive errors
1.7 Delayed recognition - # of unrelated false - positive errors
1. Hopkins Verbal Learning Test - Revised
Record scores below from the HVLT-R Test Booklet.
BENTON JUDGMENT OF LINE ORIENTATION
Benton Line Orientation Test Permissions The Benton Judgment of Line Orientation must be purchased from PAR, Inc. (http://www4.parinc.com).
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SEMANTIC FLUENCY
SUBJECT ID VISIT NO
Goodglass H. Assessment of aphasia and related disorders. Philadelphia: Lea and Febiger, 1972.
5/6/10
1 3 2 3 8
Page 1 of 1
1.
2.
3.
1. Record the number of animals named in one minute (60 seconds):
2. Record the number of vegetables named in one minute (60 seconds):
3. Record the number of fruits named in one minute (60 seconds):
LETTER NUMBER SEQUENCING Letter Number Sequencing Test Permissions Permissions for use of the Letter Number Sequencing Test as used in the PPMI study must be requested from Pearson Assessments (http://www.pearsonassessments.com/pai/ )
SYMBOL DIGIT MODALITIES TEST Symbol Digit Modalities Test Permissions Permissions for use of the Symbol Digit Modalities Test as used in the PPMI study must be requested from Western Psychological Services – WPS (http://portal.wpspublish.com).
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SYMBOL DIGIT MODALITIES TEST
SUBJECT ID
Material from the copyright © 1973, 1976, 1982 by Western Psychological Services. Format adapted by M. Hunter, University of Rochester Medical Center, for specifi c, limited research use under license of the publisher, WPS, 12031 Wilshire Boulevard, Los Angeles, California 90025, U.S.A. (www.wpspublish.com). No additional reproduction, in whole or in part, by any medium or for any purpose, may be made without the prior, written authorization of WPS. All rights reserved.
1 3 2 4 2
Page 1 of 1
VISIT NO
10/22/10
1. 1. Total correct (Response should be 0-110)
SUBJECT ID
1 3 2
VISIT NO
INITIALS SITE NO VISIT DATE
PPMI
MM DD YYYY
SUBJECT ID
1 3 2
VISIT NO
INITIALS SITE NO VISIT DATE
PPMI
MM DD YYYY
4 3
SUBJECT ID VISIT NO
PPMI
MONTREAL COGNITIVE ASSESSMENT (MOCA)
SUBJECT ID
1 3 2
VISIT NO
INITIALS SITE NO VISIT DATE
PPMI
MM DD YYYY
SUBJECT ID
1 3 2
VISIT NO
INITIALS SITE NO VISIT DATE
PPMI
MM DD YYYY
4 3
NOME:Scolarità: Data di nascita:
MONTREAL COGNITIVE ASSESSMENT (MOCA) - ITALIA -
Sesso: DATA:
VISUOSPAZIALE / ESECUTIVO Disegni un orologio (undici e dieci) PUNTI (3 punti)
[ ] [ ] [ ][ ]
Copi Il cubo
[ ] Contorno Numeri Lancette
__/ 5
DENOMINAZIONE
[ ] [ ] [ ] __/ 3MEMORIA Faccia Velluto Chiesa Margherita Rosso
1° prova Leggere la lista di parole: il soggetto deve ripeterle. Fare le prime 2 prove di seguito e il “ Richiamo ” dopo 5 min. 2° prova
0
punti
ATTENZIONE Leggere la serie di cifre Il soggetto deve ripeterle [ ] 2 1 8 5 4 ( una cifra / sec.) Il soggetto deve ripeterle in ordine inverso [ ] 7 4 2 __/ 2
Leggere la serie di lettere. Il soggetto deve dare un colpetto con la mano sul tavolo ad ogni lettera “A”. 0 punti se � 2 errori [ ] F B A C M N A A G H L B A F A H D E A A A G A M O F A A B __/ 1
Sottrazione di 7 partendo da 100 per 5 volte [ ] 93 [ ] 86 [ ] 79 [ ] 72 [ ] 65 4 o 5 sottrazioni corrette: 3 pt, 2 o 3 corrette: 2 pt, 1 corretta: 1 pt, 0 corretta: 0 pt __/ 3
LINGUAGGIO Ripeta: So solo che oggi dobbiamo aiutare Giovanni. [ ] Il gatto si nascondeva sempre sotto il divano quando c’erano cani nella stanza. [ ] __/ 2
Fluenza / In 1 minuto, nomini il maggior numero possibile di parole che iniziano con la lettera “F”. [ ] __(N � 11 parole) __/ 1ASTRAZIONE Similitudini tra per es. banana / arancio = frutti; [ ] treno / bicicletta [ ] orologio / righello __/ 2
RICHIAMO DIFFERITO Deve ricordarsi le parole SENZA AIUTO
Faccia [ ]
Velluto [ ]
Chiesa[ ]
Margherita[ ]
Rosso [ ]
Categoria Seman.
Opzionale AIUTO
Scelta multipla
Punti solo per
ripetizione SENZA AIUTO
__/ 5
ORIENTAMENTO [ ] Data [ ] Mese [ ] Anno [ ] Giorno [ ] Luogo [ ] Città __/ 6
© Z. Nasreddine. Traduzione a cura di A. Pirani, C. Tulipani, M. Neri.
Versione 26 Luglio 2006
www.mocatest.org
Normale: � 26 / 30
TOTALE __/30 Aggiungere 1 punto se � 12 anni di istruzione
SUBJECT ID
1 3 2
VISIT NO
INITIALS SITE NO VISIT DATE
PPMI
MM DD YYYY
SUBJECT ID
1 3 2
VISIT NO
INITIALS SITE NO VISIT DATE
PPMI
MM DD YYYY
<
4 3
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIEPWORTH SLEEPINESS SCALE
SUBJECT ID
© M. W. Johns 1990-1997 5/6/10
1 3 2 4 4
VISIT NO
Page 1 of 1
1. Sitting and reading
A. Source of Information: 1 = Patient, 2 = Caregiver, 3 = Patient and caregiver
2. Watching TV
3. Sitting, inactive in a public place (e.g., a theatre or a meeting)
4. As a passenger in a car for an hour without a break
5. Lying down to rest in the afternoon when circumstances permit
6. Sitting and talking to someone
7. Sitting quietly after a lunch without alcohol
8. In a car, while stopped for a few minutes in the traffi c
1.
A.
2.
3.
4.
5.
6.
7.
8.
How likely are you to doze off or fall asleep in situations described below, in contrast to feeling just tired?
This refers to your usual way of life in recent times.
Even if you haven’t done some of these things recently try to work out how they would have affected you.
Use the following scale to choose the most appropriate number for each situation:
0 = would never doze 1 = slight chance of dozing 2 = moderate chance of dozing 3 = high chance of dozing
It is important that you answer each question as best you can.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIREM SLEEP DISORDER QUESTIONNAIRE
SUBJECT ID
Stiasny-Kolster, K et al. The REM Sleep Behavior Disorder Screening Questionnaire - A New Diagnostic Instrument. Movement Disorders.2007; 22(16):2386-2393.
5/6/10
1 3 2 4 6
VISIT NO
Page 1 of 2
1. I sometimes have very vivid dreams. (0 = No, 1 = Yes)
2. My dreams frequently have an aggressive or action-packed content. (0 = No, 1 = Yes)
3. The dream contents mostly match my nocturnal behaviour. (0 = No, 1 = Yes)
4. I know that my arms or legs move when I sleep. (0 = No, 1 = Yes)
5. It thereby happened that I (almost) hurt my bed partner or myself. (0 = No, 1 = Yes)
6. I have or had the following phenomena during my dreams:
6.1 speaking, shouting, swearing, laughing loudly (0 = No, 1 = Yes)
6.2 sudden limb movements, “fi ghts” (0 = No, 1 = Yes)
6.3 gestures, complex movements, that are useless during sleep, e.g., to wave, to salute, to frighten mosquitoes, falls off the bed (0 = No, 1 = Yes)
6.4 things that fell down around the bed, e.g., bedside lamp, book, glasses (0 = No, 1 = Yes)
7. It happens that my movements awake me. (0 = No, 1 = Yes)
8. After awakening I mostly remember the content of my dreams well. (0 = No, 1 = Yes)
9. My sleep is frequently disturbed. (0 = No, 1 = Yes)
1.
2.
3.
4.
5.
6.1
6.2
6.3
6.4
7.
8.
9.
A. Source of Information: 1 = Patient, 2 = Caregiver, 3 = Patient and caregiver A.
PPMIREM SLEEP DISORDER QUESTIONNAIRE
SUBJECT ID
Stiasny-Kolster, K et al. The REM Sleep Behavior Disorder Screening Questionnaire - A New Diagnostic Instrument. Movement Disorders.2007; 22(16):2386-2393.
5/6/10
1 3 2 4 6
VISIT NO
Page 2 of 2
10c. parkinsonism
10f. depression
10d. RLS
10g. epilepsy
10e. narcolepsy
10h. infl ammatory disease of the brain
10i. other, specify: _______________________________
10c.
10f.
10d.
10g.
10e.
10h.
10i.
10. I have/had a disease of the nervous system: (0 = No, 1 = Yes)
10a. stroke
10b. head trauma
10a.
10b.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIREM SLEEP DISORDER QUESTIONNAIRE (GERMAN)
SUBJECT ID
Stiasny-Kolster, K et al. The REM Sleep Behavior Disorder Screening Questionnaire - A New Diagnostic Instrument. Movement Disorders.2007; 22(16):2386-2393.
5/6/10
1 3 2 4 6
VISIT NO
Page 1 of 2
2. Meine Träume haben des öfteren aggressiven oder aktionsgeladenen Inhalt. (0 = Nein, 1 = Ja)
3. Die Trauminhalte stimmen meist mit meinem nächtlichen Verhalten u¨berein. (0 = Nein, 1 = Ja)
4. Mir ist bekannt, dass ich meine Arme oder Beine im Schlaf bewege. (0 = Nein, 1 = Ja)
5. Es ist dabei vorgekommen, dass ich meinen Partner oder mich selbst (beinahe) verletzt habe. (0 = Nein, 1 = Ja)
1. Ich habe teilweise sehr lebhafte Träume. (0 = Nein, 1 = Ja)
6. Bei mir treten oder traten während des Träumens folgende Erscheinungen auf:
6.1 laut Sprechen, Schreien, Schimpfen, Lachen (0 = Nein, 1 = Ja)
6.2 plötzliche Bewegungen der Gliedmaβen,„Kämpfen“ (0 = Nein, 1 = Ja)
6.3 Gesten, Bewegungsabläufe, die im Schlaf sinnlos sind wie z.B. winken, salutieren, Mücken verscheuchen,Stürze aus dem Bett (0 = Nein, 1 = Ja)
6.4 um das Bett herum umgefallene Gegenstände wie z.B. Nachttischlampe, Buch, Brille (0 = Nein, 1 = Ja)
7. Es kommt vor, dass ich durch meine eigenen Bewegungen wach werde. (0 = Nein, 1 = Ja)
8. Nach dem Erwachen kann ich mich an den Inhalt meiner Träume meist gut erinnern. (0 = Nein, 1 = Ja)
9. Mein Schlaf ist häufi ger gestört. (0 = Nein, 1 = Ja)
1.
2.
3.
4.
5.
6.1
6.2
6.3
6.4
7.
8.
9.
A. Source of Information: 1 = Patient, 2 = Caregiver, 3 = Patient und caregiver A.
PPMIREM SLEEP DISORDER QUESTIONNAIRE (GERMAN)
SUBJECT ID
Stiasny-Kolster, K et al. The REM Sleep Behavior Disorder Screening Questionnaire - A New Diagnostic Instrument. Movement Disorders.2007; 22(16):2386-2393.
5/6/10
1 3 2 4 6
VISIT NO
Page 2 of 2
10c. Parkinson
10f. Depression
10d. RLS
10g. Epilepsie
10e. Narkolepsie
10h. entzündliche Erkrankung des Gehirns
10i. anderes, spezifi zieren: _________________________
10c.
10f.
10d.
10g.
10e.
10h.
10i.
10. Bei mir liegt/lag eine Erkrankung des Nervensystems vor: (0 = Nein, 1 = Ja)
10a. Schlaganfall
10b. Gehirnerschütterung
10a.
10b.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIGERIATRIC DEPRESSION SCALE (Short Version)
SUBJECT ID VISIT NO
Sheikh JI, Yesavage JA: Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontology: A Guide to Assessment and Intervention. 165-173, NY: The Haworth Press, 1986.
(10/16/07) 5/6/10 Page 1 of 1
1 3 2 4 8
Choose the best answer for how you have felt over the past week. (0 = No, 1 = Yes)
1. Are you basically satisfi ed with your life? 1.
2. Have you dropped many of your activities and interests? 2.
3. Do you feel that your life is empty? 3.
4. Do you often get bored? 4.
5. Are you in good spirits most of the time? 5.
6. Are you afraid that something bad is going to happen to you? 6.
7. Do you feel happy most of the time? 7.
8. Do you often feel helpless? 8.
9. Do you prefer to stay at home, rather than going out and doing new things? 9.
10. Do you feel you have more problems with memory than most? 10.
11. Do you think it is wonderful to be alive now? 11.
12. Do you feel pretty worthless the way you are now? 12.
13. Do you feel full of energy? 13.
14. Do you feel that your situation is hopeless? 14.
15. Do you think that most people are better off than you are? 15.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 1 of 14 8
Geriatrische Depressions-Skala
1. Sind Sie mit Ihrem Leben im Grunde zufrieden? ja/nein
2. Haben Sie viele Ihrer Aktivitäten und Interessen aufgegeben? ja/nein
3. Glauben Sie, daß Ihr Leben sinnlos ist? ja/nein
4. Langweilen Sie sich oft? ja/nein
5. Sind Sie die meiste Zeit über guter Stimmung? ja/nein
6. Fürchten Sie, daß Ihnen etwas Schlechtes zustoßen könnte? ja/nein
7. Fühlen Sie sich die meiste Zeit über glücklich? ja/nein
8. Fühlen Sie sich oft hilfl os? ja/nein
9. Bleiben Sie lieber zu Hause, anstatt auszugehen und neue Dinge zu erleben? ja/nein
10. Glauben Sie, daß Sie mit dem Gedächtnis mehr Schwierigkeiten haben als die meisten anderen?
ja/nein
11. Finden Sie es wunderbar, jetzt zu leben? ja/nein
12. Fühlen Sie sich unter den jetzigen Umständen als ziemlich wertlos? ja/nein
13. Fühlen Sie sich energiegeladen? ja/nein
14. Halten Sie Ihre Situation für hoffnungslos? ja/nein
15. Glauben Sie, daß es den meisten Menschen besser geht als Ihnen? ja/nein
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 1 of 14 8
SCÁLA DI AUTOVALUTAZIONE EMOZIONALE
1. Ė fondamentalmente soddisfatto della Sua vita?
SI
2. Le ė capitato spesso di abbandonare alcune delle sue attività e/o interessi?
NO
3. Pensa che la Sua vita sia vuota?
4. Ė spesso annoiato?
5. Ė spesso di buon umore?
6. Ha paura che Le stia per capitare qualcosa di brutto?
7. Ė felice di solito?
8. Le capita spesso di sentirsi debole ed indifeso?
9. Preferisce stare a casa piuttosto che uscire?
10. Crede di avere più problemi degli altri con la memoria?
11. Pensa che sia bello essere vivi?
12. Le sembra di vivere senza scopo?
13. Si sente pieno di energia?
14. Si sente in una situazione senza speranza?
15. Pensa che la maggior parte della gente stia meglio di Lei?
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 1 of 25 0
Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease(QUIP-Current-Short)
Answer ALL QUESTIONS based on CURRENT BEHAVIORSLASTING AT LEAST 4 WEEKS
Reported : _____ Patient _____ Informant* _____ Patient and Informant
Patient name: ______________________________________
Date: ______________________________________*If information reported by an informant, answer questions based on your understanding of the patient.
A. GAMBLING1. Do you or others think you have an issue with too much gambling behaviors (such as casinos, internetgambling, lotteries, scratch tickets, betting, or slot or poker machines)? __Yes __No
C. BUYING1. Do you or others think you have an issue with too much buying behaviors (such as too much of the samething or things that you don’t need or use)? __Yes __No
B. SEX1. Do you or others think you have an issue with too much sex behaviors (such as making sexual demands onothers, promiscuity, prostitution, change in sexual orientation, masturbation, internet or telephone sexualactivities, or pornography)? __Yes __No
D. EATING1. Do you or others think you have an issue with too much eating behaviors (such as eating larger amounts ordifferent types of food than in the past, more rapidly than normal, until feeling uncomfortably full, or when nothungry)? __Yes __No
2. Do you have diffi culty controlling your gambling behaviors (such as increasing them over time, or havingtrouble cutting down or stopping them)? __Yes __No
2. Do you think too much about sex behaviors (such as having trouble keeping thoughts out of your mind orfeeling guilty)? __Yes __No
2. Do you engage in activities specifi cally to continue the buying behaviors (such as hiding what you’re doing,lying, hoarding things, borrowing from others, accumulating debt, stealing, or being involved in illegal acts)? __Yes __No
2. Do you have urges or desires for eating behaviors that you feel are excessive or cause you distress (includingbecoming restless or irritable when unable to participate in the behavior)? __Yes __No
QUIP-CURRENT-SHORT 1Version 1.0 (12/01/08) (Modifi ed with permission 02/02/11)Copyright © University of Pennsylvania 2008
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 2 of 25 0
Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease(QUIP-Current-Short)
E. OTHER BEHAVIORSDo you or others think that you spend too much time….
F. MEDICATION USE1. Do you or others (including your physicians) think that you consistently take too much of your Parkinson’smedications? __Yes __No __Not Applicable
2. Do you have diffi culty controlling your use of Parkinson’s medications (such as experiencing a strong desire-for more medication, or having worse mood or feeling unmotivated at a lower dosage)? __Yes __No __Not Applicable
1. On specifi c tasks, hobbies or other organized activities (such as writing, painting, gardening, repairing ordismantling things, collecting, computer use, working on projects, etc.)? __Yes __No
2. Repeating certain simple motor activities (such as cleaning, tidying, handling, examining, sorting,ordering, or arranging objects, etc.)? __Yes __No
3. Walking or driving with no intended goal or specifi c purpose? __Yes __No
QUIP-CURRENT-SHORT 2Version 1.0 (12/01/08) (Modifi ed with permission 02/02/11)Copyright © University of Pennsylvania 2008
STATE-TRAIT ANXIETY INVENTORY State-Trait Anxiety Inventory Test Permissions The State-Trait Anxiety Inventory must be purchased from Mind Garden (http://www.mindgarden.com).
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 1 of 55 2
SCOPA-AUT
1. In the past month have you had diffi culty swallowing or have you choked?
2. In the past month, has saliva dribbled out of your mouth?
3. In the past month, has food ever become stuck in your throat?
4. In the past month, did you ever have the feeling during a meal that you were full very quickly?
6. In the past month, did you have to strain hard to pass stools?
5. Constipation is a blockage of the bowel, a condition in which someone has a bowel movement twice a week or less.
In the past month, have you had problems with constipation?
By means of this questionnaire, we would like to fi nd out to what extent in the past month you have had problems with various bodily functions, such as diffi culty passing urine, or excessive sweating. Answer the questions by placing a cross in the box which best refl ects your situation. If you wish to change an answer, fi ll in the ‘wrong’ box and place a cross in the correct one. If you have used medication in the past month in relation to one or more of the problems mentioned, then the question refers to how you were while taking this medication. You can note the use of medication on the last page.
1
never
never
never
never
never
never
regularly
regularly
regularly
regularly
regularly
regularly
often
often
often
often
often
often
sometimes
sometimes
sometimes
sometimes
sometimes
sometimes
A. Source of Information: 1 = Patient, 2 = Caregiver, 3 = Patient and caregiver A.
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 2 of 55 2
7. In the past month, have you had involuntary loss of stools?
8. In the past month, have you had diffi culty retaining urine?
9. In the past month, have you had involuntary loss of urine?
11. In the past month, has the stream of urine been weak?
10. In the past month, have you had the feeling that after passing urine your bladder was not completely empty?
12. In the past month, have you had to pass urine again within 2 hours of the previous time?
13. In the past month, have you had to pass urine at night?
Questions 8 to 13 deal with problems with passing urine. If you use a catheter you can indicate this by placing a cross in the box “use catheter”.
never
never
never
never
never
never
never
regularly
regularly
regularly
regularly
regularly
regularly
regularly
often
often
often
often
often
often
often
sometimes
sometimes
sometimes
sometimes
sometimes
sometimes
sometimes
usecatheter
usecatheter
usecatheter
usecatheter
usecatheter
usecatheter
2
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 3 of 55 2
14. In the past month, when standing up have you had the feeling of either becoming light-headed, or no longer being able to see properly, or no longer being able to think clearly?
15. In the past month, did you become light-headed after standing for some time?
16. Have you fainted in the past 6 months?
17. In the past month, have you ever perspired excessively during the day?
18. In the past month, have you ever perspired excessively during the night?
19. In the past month, have your eyes ever been over-sensitive to bright light?
20. In the past month, how often have you had trouble tolerating cold?
21. In the past month, how often have you had trouble tolerating heat?
never
never
never
never
never
never
never
never
regularly
regularly
regularly
regularly
regularly
regularly
regularly
regularly
often
often
often
often
often
often
often
often
sometimes
sometimes
sometimes
sometimes
sometimes
sometimes
sometimes
sometimes
3
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 4 of 55 2
The following questions are about sexuality. Although we are aware that sexuality is a highly intimate subject, we would still like you to answer these questions. For the questions on sexual activity, consider every form of sexual contact with a partner or masturbation (self-gratifi cation). An extra response option has been added to these questions. Here you can indicate that the situation described has not been applicable to you in the past month, for example because you have not been sexually active. Questions 22 and 23 are intended specifi cally for men, 24 and 25 for women.
The following 3 questions are only for men
Proceed with question 26
The following 2 questions are only for women
22. In the past month, have you been impotent (unable to have or maintain an erection)?
23. In the past month, how often have you been unable to ejaculate?
24. In the past month, was your vagina too dry during sexual activity?
25. In the past month, have you had diffi culty reaching an orgasm?
23a. In the past month, have you taken medication for an erection disorder? (If so, which medication?)
never
never
never
never
no
regularly
regularly
regularly
regularly
yes:
often
often
often
often
sometimes
sometimes
sometimes
sometimes
notapplicable
notapplicable
notapplicable
notapplicable
4
PPMI
SUBJECT ID VISIT NO
1 3 2 Page 5 of 55 2
© This questionnaire is made available free of charge, with the permission of the authors, to all those undertaking non-profi t and profi t making research. Future users may be requested to share data for psychometric purposes. Use of this questionnaire in studies should be communicated to the developers. No changes may be made to the questionnaire without written permission. Please use the following reference in publications:
Visser M, Marinus J, Stiggelbout AM, van Hilten JJ. Assessment of autonomic dysfunction in Parkinson’s disease: The SCOPA-AUT. Mov Disord. 2004;19:1306-12.
For further information, please contact M.Visser, Leiden University Medical Center, Department of Neurology (K5Q), P.O. Box 9600, NL-2300 RC Leiden (email: [email protected]).
The following questions are for everyone
26. In the past month, have you used medication for:
a. constipation?
b. urinary problems?
c. blood pressure?
d. other symptoms(not symptoms related to Parkinson’s disease)
no
no
no
no
yes:
yes:
yes:
yes:
5
OLFACTORY TESTING UPSIT Test Permissions The UPSIT must be purchased from Sensonics, Inc. (http://www.sensonics.com/shop/pc/home.asp).
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIUNIVERSITY OF PENNSYLVANIA SMELL ID TEST
SUBJECT ID VISIT NO
5/6/10 Page 1 of 1
1 3 2 5 4
1. Score from booklet #1:
2. Score from booklet #2:
3. Score from booklet #3:
4. Score from booklet #4:
Record score from each booklet.
1.
2.
3.
4.
5. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
IMAGING ASSESSMENTS
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIMAGNETIC RESONANCE IMAGING
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 5/6/10 Page 1 of 1
1 3 2 6 0
1. MRI scan: (0 = Not Completed, 1 = Completed) If Not Completed (0), provide reason in Comments.
1.
2. MRI data transferred to the core imaging lab at Institute for Neurodegenerative Disorders: (0 = No, 1 = Yes)
NOTE: DTI sequences at Baseline and annual visits performed at select sites only.
1b. Did MRI Scan include DTI sequences? (0 = No, 1 = Yes)
2.
1b.
3. MRI scan results (based on radiologist interpretation) are: (Baseline Only) 1 = Normal 2 = Abnormal, not clinically signifi cant 3 = Abnormal, clinically signifi cant (specify in Comments)
3.
4. Comments: ___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
1a. Date MRI scan completed: 1a.
MM DD YYYY
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIDaTSCAN IMAGING
SUBJECT ID
Copyright © 2010 University of Rochester. All Rights Reserved. 6/16/11 Page 1 of 1
1 3 2 6 2
1. SPECT imaging scan: (0 = Not Completed, 1 = Completed) If Not Completed (0), provide reason in Comments.
1.
2. SPECT imaging data transferred to the core imaging lab at Institute for Neurodegenerative Disorders: (0 = No, 1 = Yes)
2.
Note: Women of childbearing potential must have a negative urine pregnancy test result prior to injection.
Comments: ___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
1a. Date SPECT scan was completed: 1a.
MM DD YYYY
1b. Location where SPECT scan was completed? (1 = Site, 2 = IND) 1b.
1c. Injection: (1 = DaTSCAN, 2 = Beta-CIT ) 1c.
VISIT NO
BIOSPECIMEN SAMPLES
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMICLINICAL LABS
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 1/26/11 Page 1 of 1
1 3 2 5 9
1. Blood for clinical labs: (0 = Not collected, 1 = Collected) If Not Collected (0), provide reason in Comments.
1.
1a. Date shipped to central lab: 1a.
MM DD YYYY
Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMIDNA SAMPLE
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 5/6/10 Page 1 of 1
1 3 2 5 6
1. Blood sample for DNA: (0 = Not Collected, 1 = Collected)
1.
2. Volume of blood collected: (milliliters) 2.
1a. Date blood sample for DNA collected:
3. Date DNA sample shipped:
1a.
MM DD YYYY
3.
MM DD YYYY
Copyright © 2007 University of Rochester. All Rights Reserved. 8/20/10 Page 1 of 1
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
WHOLE BLOOD SAMPLE
VISIT NO
1 3 2 7 8
SUBJECT ID
1. Whole blood for storage and analysis: (0 = Not collected, 1 = Collected)
1a. Date of whole blood collection:
1.
2. Comments: ___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
1a.
MM DD YYYY
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMILABORATORY PROCEDURES
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 1/26/11 Page 1 of 3
1 3 2 5 8
1a. Time of last intake of food: (24-hour clock)
2b. Time of most recent PD medication dosing: (24-hour clock)
2. Is subject on medication for PD? (0 = No, 1 = Yes)
2a. Date of most recent PD medication dosing:
Urine Sample Collection
3. Urine for storage and analysis: (0 = Not collected, 1 = Collected)
2.
3.
3a. Date of urine sample collection:
1. Date of last intake of food:
3b. Time of urine sample collection: (24-hour clock)
3c. Time of centrifugation: (24-hour clock)
3g. Time urine sample placed in freezer: (24-hour clock)
3d. Rate of centrifugation: (xg)
3e. Duration of centrifugation: (minutes)
3f. Indicate temperature at which tube was spun: (Celsius)
3a.
MM DD YYYY
1.
MM DD YYYY
2a.
MM DD YYYY
3b. :
3c. :
3g. :
3d.
3e.
3f.
1a. :
2b. :
PPMILABORATORY PROCEDURES
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 1/26/11 Page 2 of 3
1 3 2 5 8
(PLASMA – EDTA PURPLE TOP)
6. Blood for plasma: (0 = Not collected, 1 = Collected) 6.
6a. Time of plasma sample collection: (24-hour clock)
6b. Time of centrifugation: (24-hour clock)
6h. Time plasma samples placed in freezer: (24-hour clock)
6c. Rate of centrifugation: (xg)
6d. Duration of centrifugation: (minutes)
6e. Indicate temperature at which tube was spun: (Celsius)
6i. Storage temperature: (Celsius)
6a. :
6b. :
6h. :
6c.
6g. Total number of aliquot tubes: 6g.
6d.
6f. Total volume aliquotted after spinning: (milliliters) 6f. .
6e.
6i. -
(RNA – PAXgene RED TOP)
5. Blood for PAXgene/RNA: (0 = Not collected, 1 = Collected) 5.
5b. Date PAXgene/RNA samples placed in freezer:
5a. Time of PAXgene/RNA sample collection: (24-hours at room temperature)
5c. Time PAXgene/RNA samples placed in freezer:
5d. Storage temperature: (Celsius)
5b.
MM DD YYYY
5a. :
5c. :
5d. -
Blood Sample Collection
4. Date blood samples collected: 4.
MM DD YYYY
PPMILABORATORY PROCEDURES
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 1/26/11 Page 3 of 3
1 3 2 5 8
9. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
(SERUM – RED TOP)
7. Blood for serum: (0 = Not collected, 1 = Collected) 7.
7a. Time of serum sample collection: (24-hour clock)
7b. Time of centrifugation: (24-hour clock)
7h. Time serum samples placed in freezer: (24-hour clock)
7c. Rate of centrifugation: (xg)
7d. Duration of centrifugation: (minutes)
7f. Total volume aliquotted after spinning: (milliliters)
7e. Indicate temperature at which tube was spun: (Celsius)
7i. Storage temperature: (Celsius)
7a. :
7b. :
7h. :
7c.
7g. Total number of aliquot tubes: 7g.
7d.
7e.
7i. -
7f. .
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMILUMBAR PUNCTURE
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 7/8/11 Page 1 of 3
1 3 2 6 4
1. Lumbar puncture for collection of CSF: (0 = Not collected (comment required), 1 = Collected)
C. Is subject on medication for PD? (0 = No, 1 = Yes)
1.
C.
3. Indicate needle used to collect CSF: 1 = 20g Quincke (sharp bevelled) needle 2 = 22g Quincke (sharp bevelled) needle 3 = 25g Quincke (sharp bevelled) needle 4 = 22g Sprotte (atraumatic) needle 5 = 24g Sprotte (atraumatic) needle (preferred) 6 = 18g
4. Indicate method of collecting the CSF: 1 = Gravity 2 = Syringe suction
5. Lumbar puncture performed at the: 0 = L2-L3 Interspace 1 = L3-L4 Interspace 2 = L4-L5 Interspace 3 = Unknown
6. Subject position when lumbar puncture performed: 1 = Sitting, leaned over (preferred) 2 = Lying, curled up on side 3 = Unknown
7. Time CSF collection completed: (24-hour clock)
B. Time of last intake of food: (24-hour clock)
Cb. Time of most recent PD medication dosing (24-hour clock)
3.
4.
5.
6.
2. Date CSF collected:
A. Date of last intake of food:
Ca. Date of most recent PD medication dosing:
2.
MM DD YYYY
A.
MM DD YYYY
Ca.
MM DD YYYY
7. :
B. :
Cb. :
PPMILUMBAR PUNCTURE
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 7/8/11 Page 2 of 3
1 3 2 6 4
12. Time CSF sample aliquotted: (24-hour clock)
16. Time samples were either placed in freezer or placed on dry ice: (24-hour clock)
12. :
16. :
14. Total number of aliquot tubes:
13. Total volume of CSF aliquotted after spinning: (milliliters)
18. What is the white blood cell count?18b. Indicate units:
19b. Indicate units:
20a. Indicate units:
21a. Indicate units:
Per cubic millimeter
mg/dL
mg/dL
Per microliter
g/dL
mmol/L
g/L
19. What is the red blood cell count?
20. What is the total protein?
21. What is the total glucose?
14.
13.
18.
19.
20. .
21. .
15. Was part of sample discarded due to a bloody tap? (0 = No, 1 = Yes)
17. Was part of the sample sent to local lab for analyses? (0 = No, 1 = Yes) If No, specify in Comments.
15.
17.
9. Time CSF was centrifuged: (24-hour clock) (Within 15 minutes from sample collection)
10. Rate of centrifugation for the CSF sample: (xg)
11. Temperature at which CSF tube was spun: (Celsius)
16a. Storage temperature if placed in freezer: (Celsius)
8. Volume of CSF collected prior spinning: (milliliters)
9. :
10.
11.
8.
16a. -
Per liter Other_________
Per cubic millimeter Per microliter Per liter Other_________
PPMILUMBAR PUNCTURE
SUBJECT ID VISIT NO
Copyright © 2010 University of Rochester. All Rights Reserved. 7/8/11 Page 3 of 3
1 3 2 6 4
22. Was a fl uoroscopy performed? (0 = No, 1 = Yes)
23. Was a lumbar spine fi lm performed? (0 = No, 1 = Yes)
22.
23.
22a. Date of fl uoroscopy:
23a. Date of spine fi lm:
22a.
MM DD YYYY
23a.
MM DD YYYY
24. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
LOGS & FORMS
CONCLUSION of STUDY SIGNATURE FORM
TRANSFER CONCOMITANT MEDICATION
CURRENT MEDICAL CONDITIONS ADVERSE EVENT
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMISIGNATURE FORM
SUBJECT ID VISIT NO
Copyright © 2002 University of Rochester. All Rights Reserved. (10/16/09) 5/6/10 Page 1 of 2
1 3 2 6 6
NOTE: a signature form is required for each expected study visit and telephone contact whether or not the visit or call was actually performed.
1.1 Visit Completion Status: (Include comment for any answer other than 1 or 7 under question 3, Comments.) 1 = Within visit window and conducted by investigator (or coordinator if telephone contact). 2 = Within visit window and not conducted by investigator. 3 = Not done (If visit not done enter the target visit date in the header). 4 = Out of visit window and conducted by investigator (or coordinator if telephone contact). 5 = Out of visit window and not conducted by investigator. 6 = Unscheduled Visit 7 = Other (specify)____________________________
1.1
1.3 Were all assessments for this visit completed? (0 = No, 1 = Yes) If No (0), please note assessments not completed in question 3, Comments.
1.3
In addition to the assessments covered by the CRFs specifi c to this visit, the following tasks were completed at this visit when applicable:
2.1 Status of Concomitant Medication Log: (1 = Updated log at this visit, 2 = No data updates to log; log is not blank, 3 = Subject has not reported taking any concomitant medications; log is blank)
2.1
1.2 Indicate why the subject missed the visit. 1 = Scheduling issue with the subject. 2 = Scheduling issue with the staff. 3 = Family/social issues with the subject. 4 = Subject did not return phone calls to schedule study visit. 5 = Travel Distance 6 = Medical Problems 7 = Military Duty 8 = Financial Issues 9 = Lost to Follow up (complete Conclusion of Study Participation form). 10 = Other: _____________________________________ 11 = Institutionalized
13 = Replaced by Symptomatic Therapy Visit
1.2
2.2 Status of Adverse Event Log: (1 = Updated log at this visit, 2 = No data updates to log; log is not blank, 3 = Subject has not reported any events; log is blank)
2.2
PPMISIGNATURE FORM
SUBJECT ID VISIT NO
Copyright © 2002 University of Rochester. All Rights Reserved. (10/16/09) 5/6/10 Page 2 of 2
1 3 2 6 6
I have reviewed the data entries for this visit and determined that they are complete, accurate, and consistent with source documents, if available. All entries were made by me, or by a person who is under my supervision.
STAFF CODEDATEINVESTIGATOR’S SIGNATURE
STAFF CODEDATECOORDINATOR’S SIGNATURE
3. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
2.10 Reviewed Current Medical Conditions Log information and made any necessary changes to the Current Medical Conditions Log: (1 = Updated log at this visit,
2 = No data updates to log; log is not blank, 3 = Subject has not reported any medical conditions; log is blank)
2.10
Cop
yrig
ht ©
200
9 U
nive
rsity
of R
oche
ster
. All
Rig
hts
Res
erve
d.5/
6/10
SU
BJE
CT
IDS
ITE
NO
INIT
IALS
13
2C
UR
REN
T M
EDIC
AL
CO
ND
ITIO
NS
LOG
PPM
I7
0
Page
__
of _
_
Row
#C
ateg
ory
(See
KE
Y
abov
e)
Yea
r of
D
iagn
osis
(YY
YY
)
1 =
Act
ual (
AC
T)2
= Ye
ar E
st. (
YE
AR
)
Ent
er a
ll cu
rren
t di
agno
sed
med
ical
con
ditio
ns.
Spe
cify
the
diso
rder
/dia
gnos
is a
nd u
se o
nly
one
line
per
desc
riptio
n.
DO
NO
T A
BB
RE
VIA
TE
.
Res
olve
d
0 =
No
1 =
Yes
Yea
r of
R
esol
utio
n
(Y
YY
Y)
INST
RU
CTI
ON
S: E
nter
the
sequ
entia
l row
num
ber 1
, 2, 3
, etc
.. K
EY fo
r CAT
EGO
RY:
1d =
Der
mat
olog
ical
1j
= H
epat
obili
ary
1p =
Neu
rolo
gic
(oth
er th
an d
isea
se u
nder
stu
dy)
1e
= O
phth
alm
olog
ical
1k
= R
enal
1q =
Psy
chia
tric
1f =
EN
T
1l =
Gyn
ecol
ogic
al/U
rolo
gic
1r
= A
llerg
y/Im
mun
olog
ic –
Ple
ase
note
dru
g al
lerg
ies
1g =
Pul
mon
ary
1m
= M
uscu
losk
elet
al
1s =
Oth
er1h
= C
ardi
ovas
cula
r
1n
= M
etab
olic
/End
ocrin
e1i
= G
astro
inte
stin
al
1o =
Hem
ato/
Lym
phat
ic
Cop
yrig
ht ©
200
2 U
nive
rsity
of R
oche
ster
. All
Rig
hts
Res
erve
d.
(10/
22/0
8)P
age
___
of _
__5/
6/10
SU
BJE
CT
IDS
ITE
NO
13
2C
ON
CO
MIT
AN
T M
EDIC
ATIO
N L
OG
PPM
I7
2
INIT
IALS
Ent
er a
ll m
edic
atio
ns ta
ken
at S
cree
ning
Vis
it. A
t sub
sequ
ent v
isits
rec
ord
new
med
s, a
nd c
hang
es/d
isco
ntin
uatio
n of
pre
viou
sly
liste
d m
eds.
Cha
nges
in to
tal d
aily
dos
e or
rou
te r
equi
re a
new
line
. Row
: ent
er 1
, 2,
3, e
tc. M
edic
atio
n: R
ecor
d ge
neric
nam
e; if
unk
now
n, e
nter
bra
nd n
ame.
For
mul
tiple
ingr
edie
nt m
edic
atio
ns, i
ndic
ate
stre
ngth
if p
ossi
ble,
e.g
., ca
rbid
opa/
levo
dopa
25/
100.
Dos
e: R
ecor
d do
se fo
r ea
ch a
dmin
istr
atio
n.
Dat
e: P
leas
e sp
ecify
if th
e S
tart
and
Sto
p da
tes
are
AC
TU
AL
or E
ST
IMA
TE
D. I
f the
exa
ct d
ate
is u
nkno
wn,
ple
ase
ente
r yo
ur b
est r
easo
nabl
e es
timat
e of
the
date
and
spe
cify
whi
ch p
art(
s) a
re e
stim
ated
. Ong
oing
: A
nsw
er y
es if
med
icat
ion
is s
till b
eing
take
n at
end
of s
tudy
. Ind
icat
ion:
Rea
son
for
use,
not
dru
g ca
tego
ry.
Row
#(e
.g.,
1,
2, e
tc.)
ME
DIC
AT
ION
(Lis
t gen
eric
nam
e, if
pos
sibl
e)D
OS
E
UNITS(e.g., mg, cc, ml, puffs)
FREQUENCY(e.g., qd, BID, qid, etc.)
RO
UT
E
ST
AR
T
DA
TE
(MM
/DD
/YY
YY
)
1 = Actual (ACT)2 = Day Est. (DAY)3 = Mon/Day Est (MD)4 = Month Est. (MON)
ST
OP
D
AT
E(M
M/D
D/Y
YY
Y)
1 = Actual (ACT)2 = Day Est. (DAY)3 = Mon/Day Est (MD)4 = Month Est. (MON)
ONGOING0 = No1 = Yes
IND
ICA
TIO
N
PD MED?0 = No, 1 = Yes
1 = IV2 = IM3 = PO4 = SC5 = PR6 = Sublingual7 = Inhaled8 = Topical9 = Other
0pa
roxe
tine
hydr
ochl
orid
e20
mg
qd3
10/3
0/20
032
10/3
1/20
032
0de
pres
sion
0S
AM
PL
E
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
CONCLUSION OF STUDY PARTICIPATION
SUBJECT ID VISIT NO F N L
Copyright © 2007 University of Rochester. All Rights Reserved. (11/17/09) 5/6/10
1 3 2 7 4
Page 1 of 1
2.2. Did the subject complete the study? (00 = No, 01 = Yes)
4.
4a. Specify: _______________________________________
5. Date of premature withdrawal: (Date investigator deemed the subject would no longer participate in the study)
5.
MM DD YYYY
If subject prematurely withdrew:4. What was the primary reason for withdrawal: 01 = Adverse Event (complete AE Log) 02 = Lost to Follow-up 03 = Subject withdrew consent (specify in 4a) 04 = Pregnancy 05 = Protocol violation 06 = Death of subject 07 = Investigator decision (specify in 4a) 09 = Clinical Monitor decision (specify in 4a) 10 = Sponsor decision (specify in 4a) 11 = Primary Care Physician decision (specify in 4a) 12 = Informant/Caregiver decision (specify in 4a) 13 = Institutionalized 14 = Inability to continue giving consent 15 = Other (specify in 4a)
Copyright © 2002 University of Rochester. All Rights Reserved. Page ___ of ___
SUBJECT ID SITE NO
1 3 2 ADVERSE EVENT LOGPPMI
6 8
INITIALS
(6/24/09) 1/26/11
Record all adverse events that occur during the study visit or the 7 day follow up period following an LP or DaTSCAN. Record disease entity as AE only if it worsens beyond what investigator expects is within normal range of fl uctuation for this subject. Elicit adverse event data by asking an open-ended question, e.g., “What unusual symptoms or medical problems have you experienced since the last visit?” Record any new or change in ongoing sign or symptom as well as any event that has resolved since last evaluation. Enter each change in “severity” on new line. Date: Please specify if the Start and Stop dates are ACTUAL or ESTIMATED. If the exact date is unknown, please enter your best reasonable estimate of the date and specify which part(s) are estimated. IF EVENT IS A SERIOUS ADVERSE EVENT, please refer to the Operations Manual for reporting guidance.
AE #(e.g., 1, 2, etc.)
Adverse Event (Record diagnosis if known)
START DATE
(MM/DD/YYYY)
1 =
Act
ual (
AC
T)
2 =
Day
Est
. (D
AY
)3
= M
on/D
ay E
st (
MD
)4
= M
onth
Est
. (M
ON
) STOP DATE
(MM/DD/YYYY)
1 =
Act
ual (
AC
T)
2 =
Day
Est
. (D
AY
)3
= M
on/D
ay E
st (
MD
)4
= M
onth
Est
. (M
ON
)
Severity SAE Relationship to Study*
Related to Study
Procedure
0 = No 1 = Yes
Che
ck b
ox if
this
eve
nt r
esul
ted
in
with
draw
al fr
om th
e st
udy
Complete when resolved or at Final Visit
Primary OutcomeAE Status at Final Visit
1 =
mild
2 =
mod
erat
e3
= s
ever
e0
= N
o1
= Y
es (
If Y
es, c
all
Coo
rdin
atio
n C
ente
r)
1 =
unr
elat
ed2
= u
nlik
ely
3 =
pos
sibl
e4
= p
roba
ble
5 =
defi
nite
1 =
rec
over
ed
2 =
und
er tr
eatm
ent/
obse
rvat
ion
3 =
cha
nge
in A
E
char
acte
ristic
4 =
seq
uela
e5
= fa
tal
6 =
unk
now
n
If unresolved, is follow-up required?0 = No1 = Yes
STAFF CODEDATEINVESTIGATOR’S SIGNATURE
* If 3, 4 or 5 are selected, complete “Related to Study Procedure”.
DaT
SC
AN
LP Oth
er
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI
SUBJECT SITE TRANSFER FORM
SUBJECT ID VISIT NO X
Copyright © 1999 University of Rochester. All Rights Reserved. (7/16/08) 5/6/10
1 3 2 7 6
Page 1 of 1
1. Date of re-consent:
2. 2. Transferring site number:
NOTE: To be completed by the new site.
1.
MM DD YYYY
Visit Number BL V01 V02 V04
Visit Description Months ( +30 days) 0 3 6 12
Subject Eligibility 78 X
OPDM Use Questionnaire 80 X
OPDM Assessment 82 X X X X
Conclusion of Study Participation 84 X
7/8/2011
PPMI (TAP-PD) Schedule of Activities
PARKINSON DISEASE (PD) SUBJECTS
TAPFNLLevel #
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI (TAP-PD)
SUBJECT ELIGIBILITY
SUBJECT ID
7/8/11
1 3 2 7 8
VISIT NO
Page 1 of 1Copyright © 2011 University of Rochester. All Rights Reserved.
SUBJECT INCLUSION CRITERIA (0 = No, 1 = Yes)
SUBJECT EXCLUSION CRITERIA (0 = No, 1 = Yes)
1. PD subject who is otherwise eligible for enrollment into PPMI.
2. Enrolled at one of three participating sites:
3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
4. Willing and able to complete additional study procedures.
1. Evidence of “atypical” parkinsonian syndromes (e.g. Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, Lewy body dementia).
2. Any medical condition other than PD that would interfere with the subject’s ability to perform study procedures as determined by the investigator.
1.
2.
3.
4.
1.
2.
To be ELIGIBLE for study participation ALL answers to items 1-4 must be 1 = Yes.
B. Date informed consent was signed:
ENROLLMENT
1. Date subject was enrolled into TAP-PD:
A. Check box if subject has signed consent.
B.
MM DD YYYY
1.
MM DD YYYY
To be ELIGIBLE for study participation ALL answers to items 1 and 2 must be 0 = No.
Oregon Health Sciences University, Portland, OR• Institute for Neurodegenerative Disorders, New Haven, CT • University of Pennsylvania Movement Disorders Center, Philadelphia, PA•
2. Indicate the serial number of the OPDM device sent home with the subject.
2.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI (TAP-PD)
OPDM USE QUESTIONNAIRE
SUBJECT ID VISIT NO
7/8/11
1 3 2 8 0
Page 1 of 1Copyright © 2011 University of Rochester. All Rights Reserved.
1. How hard was it to understand the directions for using the OPDM dexterity device? 0 = Not at all hard to understand 1 = A little bit hard to understand 2 = Moderately hard to understand 3 = Very hard to understand
1.
Please respond to the questions below to tell us about your experience with the use of the OPDM home dexterity device.
2. How confi dent were you that you were doing the tasks correctly? 0 = Not at all confi dent 1 = A little bit confi dent 2 = Moderately confi dent 3 = Very confi dent
2.
3. Did doing the OPDM dexterity tasks at home fi t into your regular schedule? 0 = It was easy to fi t into my day 1 = I had a little trouble fi tting it into my day 2 = It was moderately diffi cult to fi t into my day 3 = It was very diffi cult to fi t into my day
3.
4. Did you need to be reminded (by family members or study staff) to complete the OPDM dexterity device tasks? 0 = Not at all 1 = Rarely (1 or 2 times) 2 = Sometimes (3 - 5 times) 3 = Often (more than 5 times)
4.
5. Did doing the OPDM dexterity tasks at home change the way you felt about participating in the main PPMI study? 0 = Felt a lot more negative 1 = Felt a little more negative 2 = No change 3 = Felt a little more positive 4 = Felt a lot more positive
5.
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI (TAP-PD)
OPDM ASSESSMENT
SUBJECT ID
7/8/11
1 3 2 8 2
VISIT NO
Page 1 of 1Copyright © 2011 University of Rochester. All Rights Reserved.
1. Was the OPDM assessment completed at this visit? (0 = No, 1 = Yes)
3. Were the following tasks completed for the OPDM assessment? (If “No”, indicate in Comments)
3.1 Digitography (keyboard test) (0 = No, 1 = Yes)
3.2 Paced Keyboard Test (0 = No, 1 = Yes)
3.3 Pegboard (0 = No, 1 = Yes)
4. Was the OPDM data that was collected at this visit transferred to Kinetics? (0 = No, 1 = Yes) (If “No”, indicate in Comments)
5. Date the OPDM data for this visit was transferred to Kinetics:
1.
3.1
4.
5.
MM DD YYYY
2. Indicate the serial number of the OPDM device used for this subject.
2.
3.2
3.3
6. Comments:
_______________________________________________________________
_______________________________________________________________
_______________________________________________________________
SITE NOINITIALS VISIT DATE
MM DD YYYY
PPMI (TAP-PD)
CONCLUSION OF STUDY PARTICIPATION
SUBJECT ID VISIT NO T A P F N L
Copyright © 2007 University of Rochester. All Rights Reserved. (12/9/10)
1 3 2 8 4
Page 1 of 17/8/11
2.2. Did the subject complete the study? (00 = No, 01 = Yes)
5. Date of premature withdrawal: (Date investigator deemed the subject would no longer participate in the study)
5.
MM DD YYYY
If subject prematurely withdrew: