(Letterhead) - advancestudy.files.wordpress.com€¦ · Web viewBASELINE INFORMED CONSENT FOR RESEARCH. CONSENT FOR PARTICIPATION IN A STUDY TITLED: ADvance: A 12-month double-blinded,

BASELINE INFORMED CONSENT FOR RESEARCH

CONSENT FOR PARTICIPATION IN A STUDY TITLED: ADvance: A 12-month double-blinded, randomized, controlled feasibility study to evaluate the safety, efficacy and tolerability of deep brain stimulation of the fornix (DBS-f) in patients with mild probable Alzheimer’s disease

PLEASE READ THIS FORM CAREFULLY AND COMPLETELY BEFORE SIGNING

Name of Participant: _________________________________________________

Investigator (Study Doctor): ____________________________________________Study Contact Information:Dr. _______________Phone: (XXX) XXX-XXXXAddress:

WHAT IS THIS STUDY ABOUT?

This form is an invitation to take part in an investigational research study called the “ADvance Study”, and it provides information that will assist you in making an informed decision about whether or not you wish to take part. If you decide to take part, you will be given a copy of this Informed Consent Form to keep.

A research study tests new treatments in subjects to find out whether the treatments are safe. It also tests to see if the treatment works for a certain disease. You have been diagnosed with mild Alzheimer’s disease. You are being invited to take part in a research study using electrical brain stimulation (the delivery of electrical pulses to your brain), also known as deep brain stimulation (DBS) to treat your Alzheimer’s disease. This stimulation will be given to the fornix, a place in your brain that plays a central role in memory. It is believed that stimulating this area with a carefully controlled electrical stimulation may impact your memory. The treatment is called DBS-f, and your doctor has determined that you might meet the study requirements and that DBS-f is a potential treatment for slowing the progress of your Alzheimer’s disease.

You are being asked to read this document to ensure that you are informed of the nature of this research study and how you will take part in it, if you wish to do so. Before agreeing to take part in this study, it is important that you read and understand the following explanation of the proposed study procedures. The following information describes the purpose, procedures, benefits, discomforts, risks and safety measures associated with this study. It also describes your right to refuse to take part or withdraw from the study at any time. In order to decide whether you want to take part in this research study, you should understand enough about its risks and benefits to be able to make an informed decision. This is known as the informed consent process.

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Please ask the study doctor or study staff to explain any words you do not understand before signing this consent form. Make sure all of your questions have been answered to your satisfaction before signing this document.

Functional Neuromodulation ., referred to as FNM, is the sponsor of the ADvance Study. They may work with other companies to manage the day-to-day operations of the study. When you see “FNM” in this document, it refers to FNM and anyone working on behalf of these two companies.

WHY IS THIS STUDY BEING DONE?

Alzheimer’s disease (AD) is a brain disease that slowly destroys the memory and the ability to think, learn, communicate, and handle daily activities. While there are a few medications and treatments that can be used to treat some of the symptoms of Alzheimer’s disease, there is no way to stop the progress of the disease or to stop memory loss due to Alzheimer’s disease. Electrical brain stimulation, also called deep brain stimulation (DBS) is commonly used to treat movement disorders such as Parkinson disease. DBS therapy consists of leads (wires) or electrodes designed to target specific areas of the brain and are connected to a power source (generator or battery) implanted (placed) under the skin in your chest near the collarbone.

You have been diagnosed as having mild Alzheimer’s disease. Standard treatment for people with mild AD is to receive cholinesterase inhibitors (medications to treat the symptoms (memory loss, confusion, and problems with thinking and reasoning) of Alzheimer's disease), such as donepezil (brand name Aricept), rivastigmine (brand name Exelon), or galantamine (brand name Razadyne). You are currently taking one of these medications.

The purpose of this study is to see what benefits and associated risks of deep brain stimulation of the fornix (DBS-f) exist in patients with mild Alzheimer’s disease. This study will look at the effects in patients with mild Alzheimer’s disease who are already taking one of the medications mentioned above for the treatment of AD. The system (the wires and battery that generates the electricity) to deliver the deep brain stimulation is already approved for use in the treatment of movement disorders such as Parkinson’s disease so it is not experimental for that purpose. However, using the system for stimulating the brain for Alzheimer’s disease is experimental. Your participation is voluntary. To be considered for this study, you must meet the study entry criteria, have mild Alzheimer’s disease, take a medication called a cholinesterase inhibitor, and be willing to take part in the clinical investigation by signing this consent.

HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?

The study will involve about 20 men and women between the ages of 55 and 80 that have been diagnosed with mild Alzheimer’s disease, like yours. The study will be conducted at about 6 research sites in the United States and Canada.

HOW LONG WILL I BE IN THIS STUDY?

Following the baseline visit and implantation of the device, scheduled follow-up visits will occur at 2 weeks post-implant and at months 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24. After 24 months, you


will no longer be required to participate in this study. Another long-term safety study will be offered to you so that you can continue to be followed with your study doctor.

WHAT WILL HAPPEN TO ME DURING THIS STUDY?

ASSESSMENT PHASE

SCREENING VISIT: You have already completed the screening visit and it has been determined that you still meet the study requirements. There is still a chance that you will not get the study devices based on additional screening described here.

BASELINE VISIT: The second visit is called the baseline visit. It is usually done the day before your surgery. At the time of the baseline visit, you will again have tests to determine your current level of physical abilities and thinking patterns. The questionnaires for this visit will take about 3 hours to complete. You will have a physical exam to make sure there have been no health changes since your last visit, review the medications you are taking with your doctor, and have your blood drawn. You will also have positron emission tomography (PET) imaging to measure the brain’s use of glucose and magnetic resonance imaging (MRI) to study the brain structure and to help your surgeon see the area in your brain where the wires will be placed. PET scans are performed by taking images of the brain. For each PET scan, a small plastic tube (intravenous (or IV) line) will be inserted into a vein in your arm and a sugar-like substance (called [18F]-fluorodeoxyglucose) will be injected. This substance contains small amounts of radioactive fluorine. A sample of blood (approximately 6 teaspoons) will be taken at 15 minutes after the substance is injected by a second IV line that will be inserted into a vein in your other arm.

The PET scan will take about 2 hours to complete.

A MRI is a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body. It usually takes 30 to 60 minutes, but can take up to 2 hours.

You will complete several questionnaires at this visit. A family member or your primary caregiver might be present during these questionnaires and, in some cases, might be asked to assist in completing them. The questionnaires include:

Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog-13) – This is a questionnaire that looks at your word recognition, word recall and other mental abilities.

Clinical Dementia Rating (CDR) - This is an interview that collects information from both your caregiver and from you. Your performance is assessed in memory, orientation, judgment, problem solving, community activities, home and hobbies and personal care.

California Verbal Learning Test (CVLT) – This is used to assess your verbal memory abilities.

Digit span measures attention and working memory. Digit symbol measure visual perception. Letter fluency measures ability to recall words beginning with s and p. The Trail Making Test measures visual-motor skills. Brief Visuospatial Memory Test measures visual and spatial memory.


Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) – This is a 23-item questionnaire to assess the impact that your Alzheimer’s disease has on your daily life.

QOL-AD - This is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver.

The Zarit Burden Interview (ZBI) measures subjective burden among caregivers of adults with dementia.

Neuropsychiatric Inventory Questionnaire (NPI-q) – This is a questionnaire that asks you or your caregiver about behavioral changes due to your Alzheimer’s disease.

Your doctor will review all your information. If your medical and test results continue to meet the study criteria, you will be scheduled for the implant of the DBS-f system.

IMPLANT PHASE

You will go to the operating room and be given general anesthesia (medication that will make you sleep). The DBS-f system includes the Activa PC Neurostimulator implantable pulse generator (made by Medtronic, Inc) and two leads (wires) that attach to the pulse generator and deliver electrical pulses to your brain. The procedure involves placing a frame on your head which helps the surgeon insert the wires. You will have an MRI with the frame on to help the surgeon place the wires. Your surgeon will implant the wires on both sides of your brain next to an area called the fornix. Once the wires are implanted, the battery (Activa Neurostimulator) will be placed under the skin of your chest. The Activa Neurostimulator resembles a pacemaker. It has a battery and electronics inside a titanium (a strong metal) shell. The wires are implanted beneath the skin in your neck and connected to the can in your chest. Once the surgery is complete, you will go to a recovery room. You will be discharged home 1-3 days later. Before you leave the hospital, repeat brain imaging using MRI and blood tests will be done.

The MRI after surgery is to see if the leads are still in the right spot in your brain. If they have moved and your surgeon thinks that the placement is not the best, you will still be randomized. You will have one of three options:

1. Your surgeon may want to take you back to surgery and operate to reposition the leads. If the leads can be repositioned successfully (as determined by another MRI scan), you can then be randomized; if the lead repositioning is not optimal, you will be given one of the other options below.

2. You will be part of the randomized study and will be followed with all the same protocol-required tests, below; or

3. You may have your device removed. You will be seen approximately 1 month after your initial device implant for a safety visit. Your study doctor may continue to see you, so talk to your doctor about your long term treatment plans. You will not be randomized if you choose this option.

FOLLOW-UP PHASE


At every follow-up visit beginning with your 1-month visit, you will meet with a psychiatrist at the research site. This psychiatrist will ask you questions to determine if you have new major neurological disorders such as schizophrenia, bipolar disorder, or other major depressive disorders. They will also ask you and your caregiver about any suicidal thoughts or suicide attempts. If you have any of these disorders or if your scores on some of the psychiatric evaluations are out of an acceptable range for this study, you will be withdrawn from participation in the study.

WEEK 2 VISIT: You will return to the clinic two weeks after the implant for a general assessment, which includes the following tests, procedures and questionnaires:

Physical exam Questions will be asked about the medications that you are taking Your study doctor or study nurse will ask you questions about your general health and

whether or not you have had any side effects since your surgery

RANDOMIZATION:After these assessments are completed, you will be randomly assigned (like the flip of a coin) to one of two groups. The two groups are:

1. DBS-f On - At your Week 2 visit, your device will be turned “on”. You will not be told if your device was turned on at this time.

2. DBS-f Off - At your Week 2 visit, your stimulation will be left “off”. You will not be told if your device was left off at this time.

Information about living with DBS system will be reviewed with you by trained clinic personnel. If you are assigned to the DBS-f On group, your device will be turned on for the duration of the study. If you are in the DBS-f Off group, your device will not be turned on for the first 12 months. It will be turned on after 12-months.

Your device will be tested during this visit and at other visits during the study. During the device testing, a member of the study team will turn on your device and will change the device settings. During this testing process, you may have some side effects of the system like déjà vu (feeling as though you have previously experienced a situation) or other similar experiences. Your study doctor will explain the testing to you and will give you instructions on how to report these experiences prior to the testing.

This visit will take about 2 hours to complete.

One Month Visit: You will return to the clinic one month after your implant visit. At this visit, the following tests and assessments will be completed:

Physical exam Blood draw Questions will be asked about the medications that you are taking

Columbia Suicide Severity Rating Scale (C-SSRS)


Cornell Scale for Depression and Dementia (CSDD).

Young Mania Rating Scale (YMRS).

Your study doctor or study nurse will ask you questions about your general health and whether or not you have had any side effects since your surgery.

ADAS-cog PET Scan

Your device settings may be adjusted if needed. This visit will take about 2-3 hours to complete.

Three Month Visit: You will return to the clinic for a visit three months after your implant visit. At this visit, the following tests and assessments will be completed:

Physical exam Questions will be asked about the medications that you are taking C-SSRS CSDD YMRS Your study doctor or study nurse will ask you questions about your general health and

whether or not you have had any side effects since your surgery Questionnaires:

o Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog-13) o Clinical Dementia Rating- Sum of Boxes (CDR-SB)o California Verbal Learning Test (CVLT)o Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) o Neuropsychiatric Inventory Questionnaire (NPI-q) o Letter Fluencyo The Trail Making Test o Brief Visuospatial Memory Test (BVMT-R)o QOL-AD


Six Month Visit: You will return to the clinic for a visit six months after your implant visit. At this visit, the following tests and assessments will be completed:

Physical exam Blood draw Questions will be asked about the medications that you are taking C-SSRS CSDD YMRS Your study doctor or study nurse will ask you questions about your general health and


o Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog-13)o Clinical Dementia Rating- Sum of Boxes (CDR-SB)o California Verbal Learning Test (CVLT)


o Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) o Neuropsychiatric Inventory Questionnaire (NPI-q) o Letter Fluencyo The Trail Making Testo Brief Visuospatial Memory Test (BVMT-R)o QOL-ADo The Zarit Burden Interview (ZBI)

PET ScanYour device settings may be adjusted if needed. This visit will take about 4-6 hours to complete.

Nine Month Visit: You will return to the clinic for a visit nine months after your implant visit. At this visit, the following tests and assessments will be completed:

Physical exam Questions will be asked about the medications that you are taking C-SSRS CSDD YMRS Your study doctor or study nurse will ask you questions about your general health and


o Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog 13)o Clinical Dementia Rating- Sum of Boxes (CDR-SB)o California Verbal Learning Test (CVLT)o Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) o Neuropsychiatric Inventory Questionnaire (NPI-q)o Letter Fluencyo The Trail Making Testo Brief Visuospatial Memory Test (BVMT-R)o QOL-AD


Twelve Month Visit: You will return to the clinic for a visit twelve months after your implant visit. At this visit, the following tests and assessments will be completed:




o Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog 13) o Clinical Dementia Rating- Sum of Boxes (CDR-SB)o California Verbal Learning Test (CVLT)o Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) o Neuropsychiatric Inventory Questionnaire (NPI-q) o Letter Fluencyo The Trail Making Testo Brief Visuospatial Memory Test (BVMT-R)o QOL-ADo The Zarit Burden Interview (ZBI)

MRI Scan PET Scan


At the end of this visit, your study doctor can tell you which treatment group you were assigned to (DBS-f On or DBS-f Off) if all other patients have also already completed this visit. Otherwise, you will be told of your treatment assignment at a later visit. At the end of this visit you will have your system turned “On”.

Month 13 Follow-up Visit (± 30 days): Only the group randomized to off initially (DBS-off) are required to continue to have a follow-up visit at 13 months post-implant. This is a safety evaluation performed to assess subjects one month after being turned on. In addition to an adverse event assessment, the following tests/data will be collected at this visit. Physical Exam Questions will be asked about the medications that you are taking Blood Draw Device testing Psychiatric Consult - A staff psychiatrist will evaluate you. The psychiatrist will look for the

following conditions and will conduct the necessary assessments: Your study doctor or study nurse will ask you questions about your general health and

whether or not you have had any side effects since your surgery Suicidal ideation or suicide attempts. CSDD YMRS C-SSRS

Month 15: You will be asked to return to the clinic 15 months and after your implant visit. At each of these visits, the following tests and assessments will be completed:

Physical exam Questions will be asked about the medications that you are taking C-SSRS CSDD


YMRS Your study doctor or study nurse will ask you questions about your general health and


Your device settings may be adjusted if needed. Each of these visits will take about 2 hours to complete.




o Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog 11) o Clinical Dementia Rating- Sum of Boxes (CDR-SB)o California Verbal Learning Test (CVLT)o Digital Spano Digital Symbolo Letter Fluencyo Trail Making Testo Brief Visuospatial Memory Testo Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL)o Alzheimer’s Disease Quality-of-Lifeo Zarit Caregiver Burden o Neuropsychiatric Inventory Questionnaire (NPI-q)



Physical exam Questions will be asked about the medications that you are taking C-SSRS CSDD YMRS NPI Your study doctor or study nurse will ask you questions about your general health and







o Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-cog 11) o Clinical Dementia Rating- Sum of Boxes (CDR-SB)o California Verbal Learning Test (CVLT)o Digital Spano Digital Symbolo Letter Fluencyo Trail Making Testo Brief Visuospatial Memory Testo Alzheimer’s Disease Cooperative Study- Activities of Daily Living (ADCS-ADL)o Alzheimer’s Disease Quality-of-Lifeo Zarit Caregiver Burden o Neuropsychiatric Inventory Questionnaire (NPI-q)


After you complete the 24-month visit, you will not be required to come to any more visits for the study and you will be told which treatment group you were in (“on” or “off”). You will be offered to take part in another long-term follow-up study. The long-term follow-up study will require you to return to your study doctor for routine check-ups. Another form like this one will be provided to you before you decide if you want to join the long-term follow-up study. If you do not choose to join the long-term follow-up study, your study doctor may wish to continue to see you so talk to your study doctor or study nurse if you have any questions about your future care.

WHAT ARE THE RISKS OF THE STUDY?

Surgery and Procedure Related RisksDeep brain stimulation (DBS) is approved by the FDA, Health Canada and other regulatory agencies around the world to treat movement disorders such as Parkinson’s disease. The surgical procedure and implantable devices are the same for Alzheimer’s disease, and it is anticipated that the types of adverse events observed for this treatment of Alzheimer’s disease would be similar.


While the target site of the DBS is different, the treatment for movement disorders experience also provides information about the surgical and procedural risks of the treatment. The risks associated with this study are outlined below. As with any medical procedure, there is the possibility of unforeseen risks to the study subject.

You will be placed under general anesthesia (you will be asleep) for your procedure. There are some possible risks and complications related to the general anesthesia. There is a small risk of lung infections, strokes, heart attacks and possibly death during or after anesthesia. The risks are small and are more likely in older patients and patients who have medical problems or have a previous history of strokes or heart attacks. Nausea and vomiting could occur after anesthesia and are usually dealt with by using drugs to stop the nausea.

Implanting the DBS neurostimulator system carries similar risks to those associated with other brain surgery procedures:

Death may occur as a result of the surgical procedure. Based on similar studies for other diseases the risk is estimated at about 0.5% or 5 out of 1000. Causes listed were heart attack, bleeding in the skull and blockage of a main artery in the lung.

Hemorrhage (bleeding in your skull) may occur at a low rate (approximately 4-5%). About half of the bleeds that occur are not noticeable and about half are noticeable. Noticeable symptoms may be mild or serious. They could be temporary and resolve over time or permanent. The result of a noticeable hemorrhage could be serious and can result in the following: death, coma, paralysis, stroke, muscle weakness and loss of speech/difficulty speaking

Seizures may occur at a very low rate. Historically about 1% of the patients experience a seizure associated with a DBS procedure.

Infections may occur. It has been reported to be about 10%. Almost all infections are at the pocket site where your battery (stimulator) was implanted. About half the time the battery has to be removed. In about half of the cases, patients were treated with antibiotics and recovered. Serious brain infection can occur but it is rare – lower than 1 in 1000.

Lead breakage or movement may occur (about 3%) and may need you to undergo another surgical procedure to fix.

Depression, memory impairment, confusion, anxiety, skin tingling, dizziness and headache may occur. They range from 7-15%. Depression, suicidal thoughts and suicide have been reported in patients receiving Medtronic DBS Therapy for Movement Disorders, although no direct cause and effect relationship has been established. We have put in place a close monitoring program in this study to detect and manage these symptoms if they occur.

General complications that may occur with any surgical procedure include: Deep vein thrombosis (a blood clot in a deep vein) Phlebitis (inflammation of a vein) Pneumonia Urinary infections

Pulmonary embolism (a blockage of one or more arteries of the lung)


Reaction to anesthetic agent Nausea and/or vomiting

Based on clinical studies for other uses of this system, the following complications may occur in more than 5% (1 out of every 20) patients. The number after each item shows you how often this happened in the other studies, which might be different in this study.

Depression (14.8%) Memory impairment (13.0%) Confusion/confusional state (7.3%) Anxiety (9.3%) Paresthesia (9.3%) Dizziness (7.3%) Headache (5.5%)

Adverse events that are clearly device related include: Broken lead (wire) or extension Infection

Erosion (wearing away) of a system component through the skin Can, Lead (wire) or extension connector migration (movement out of place) Persistent pain at the neurostimulator site Seroma (collection of fluid) or hematoma (collection of blood outside the blood

vessels) at the neurostimulator site Loss of therapeutic effect of the system Shocking or jolting stimulation Visual disturbances Sensory changes Cerebral spinal fluid leak (fluid around your spinal column near your brain) Allergic or immune system response to the implanted materials

In addition to those noted above, the following adverse events are possible: Experiential phenomena (visual or auditory hallucinations or illusions, memory

flashbacks, illusions of familiarity, forced thinking, or emotions) Flushing Sweating Increased heart rate Increase blood pressure


Suicidal thoughts Adverse cognitive or psychiatric effects Perceptions described as déjà vu (feeling as though you have previously experienced

a situation) Unpleasant generalized warming Transient flashes of light

You will be having laboratory and diagnostic testing that include the following: Blood draw:

Requires a needle stick that may hurt There is a small risk of bleeding, bruising, or infection at the puncture site

PET brain scan The radiation dose to you from the 4 PET scans is 1.83 rem (a rem is a unit of

absorbed radiation). This is more than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food and soil. It is less than the 5 rems of radiation that is allowed each year for people who are exposed to radiation in their jobs. The potential long-term risk from the radiation dose you will receive is uncertain, but these doses have never been associated with any definite adverse effects. The risk to you, if any, is estimated to be slight. There is also a risk of bruising or infection at the site of injection.

MRI: The presence of metal in your body may be a safety hazard or affect a portion of the

MRI image. Prior to your exam, you will be asked to complete a standard questionnaire. The purpose of this questionnaire is to ensure that you are able to safely enter the MR area. Some questions refer to possible exposure to metal in your eyes and face. If you have had such exposure, you will not be allowed to have an MR for this research study. This may exclude you from the study.

The MRI requires that you lie in a closed area inside the magnetic tube. This may cause a feeling of claustrophobia (fear of being closed in small spaces) for some. This can be relieved with medication prior to the procedure. If your symptoms are severe, you may be excluded from the study.

There is the potential risk of interaction between the MRI and the DBS system resulting in heating and damage to the implanted system or causing the neurostimulator to move. This could cause serious and permanent injury including coma, paralysis, or death. Additional risks include skin burns, pain, discomfort, shocking sensation/uncomfortable stimulation, or opening of a recent incision. Since it is important to accurately verify that your leads (the wires in your brain) are in the right spot after the implant, it is believed that the benefit of an MRI exceeds the risks associated with the procedure.

Surgical frame: Your scalp may be red, irritated or sensitive at sites where the surgical frame is

attached to your head during the surgery. Rarely, people experience temporary hair loss.


Pregnancy It is unknown what effect electrical brain stimulation will have on a developing fetus or sperm. Therefore, women are required to be sterile, post menopausal or using adequate birth control of your choice during your participation in this study. If by any chance you or your spouse becomes pregnant while participating in the study, to protect the safety of your baby you will be discontinued from the study and your DBS will be turned off or removed.

Unforeseeable RisksThere may be other complications that are not yet known, which may occur either during or immediately after the procedure or once you have been released from the hospital or clinic. The study has been designed to specifically address the known, anticipated and unknown risks. Your doctor will make every effort to lessen these risks as well.

What if I experience one of these risks?If you or your caregiver believes that you are experience one of these risks and you wish to speak to someone immediately about this, you can contact your study doctor at the information listed at the top of the first page of this informed consent form. In particular, you or your caregiver should contact your study doctor immediately if you or your caregiver believes that you develop any suicidal thoughts, attempts of suicide, worsening depression and mania.

WILL I BENEFIT FROM THIS STUDY?

Observations from early studies suggest there may be the potential for diminished rate of decline in cognitive function including specific aspects of memory and possible improvements in quality of life measures related to Alzheimer’s disease. At this time, it is impossible to say that patients will benefit from participation in this study. DBS-f will not cure Alzheimer’s disease. Information learned from this study may benefit other patients in the future with Alzheimer’s disease and may help to design future clinical trials.

WILL MY MEDICAL INFORMATION BE KEPT PRIVATE?

During the study, information about you will be obtained from blood tests, psychological tests, imaging procedures, and from your medical record. All information obtained during the study will be held in strict confidence. If you decide to take part in this study, you grant the study sponsor (FNM,) or its representatives, the Food and Drug Administration (FDA), Health Canada, the IRB/EC (institutional review board or ethics committee) at your hospital and possibly other governmental agencies permission to obtain information about your medical condition from your medical records before, during and after the study. Your doctor will provide only the necessary information related to the study to the study sponsor. The results of this study may be published, but your identity will remain anonymous. You may decide to leave the study at any time. However, if you do, the investigator will still use the study data that was collected before you left the study.

Patient registration numbers do not contain information that can be traced directly to you such as your name or Social Security number. All personnel working on this study are trained on the importance of using patient registration numbers that protect your privacy. The utmost of care is


used to make sure that all your information is secure. Study information will be sent to FNM where it will be entered into a secure, password-protected database.

Some uses and disclosures of your information will be necessary in order to conduct the study. Therefore, you agree to permit your doctors and other health care providers, their staff, the research center, and its Institutional Review Board or “IRB” or Ethics Committee or “EC” (together known as “Health Care Providers”) as well as FNM to create, obtain, use and disclose certain information that identifies you (known as the “Study Data”) as described below:

Your Study Data includes:

All information about you collected during this study

All information in your medical records that is relevant to this study

All information related to payments for items or services furnished to you during this study, including bills for hospital care, physician services, outpatient services, laboratory tests, diagnostic procedures, home care services and drugs (together known as “Payment Information”)

You agree that the Health Care Providers may:

Use and disclose your Study Data to conduct this study

Disclose your Study Data to FNM as the sponsor of the study

Use and disclose your Payment Information

Disclose your Study Data to government agencies (including the FDA, Health Canada and other foreign regulatory agencies), review boards and other persons who oversee the safety and effectiveness of medical products and therapies and the conduct of research; and

Remove your name and other identifying information from the Study Data for publication and other uses.

You agree that FNM may:

Use and disclose your Study Data to conduct this study

Use and disclose your reimbursement information (this might include: copies of bills for hospital care, physician services, outpatient services, laboratory tests, diagnostic procedures, home care services and drugs)

Disclose your Study Data to government agencies (including the FDA, Health Canada and other foreign regulatory agencies), Medtronic, Inc., the manufacturer of the deep brain stimulation system, review boards and other persons who oversee the safety and effectiveness of medical products and therapies and the conduct of research

Maintain and use your Study Data as part of an ongoing research database

Use and disclose your Study Data after the end of this research study for use in future research and other business purposes


Remove your name and other identifying information from the Study Data for publication and other uses.

FNM and Medtronic, Inc. will keep your health information confidential in accordance with all applicable laws and regulations. FNM and Medtronic, Inc. may use your health information to conduct this research, as well as for additional purposes, such as new medical research and proposals for developing new medical products or procedures, and other business purposes. Your name will not be placed on any mailing lists or sold to anyone for marketing purposes. There are standard risks of participating in a research study which include the loss of confidentiality. Every attempt will be made to ensure that your personal information remains confidential.

Once your health information has been disclosed to a third party, federal privacy laws may no longer protect it from further disclosure. No publication about this study will reveal your identity without your specific written permission. These limitations continue even if you revoke (take back) this consent.

This permission does not have an expiration (ending) date, but you may change your mind and revoke (take back) this permission to use your health information at any time. To revoke this permission, you must write to [name and contact information]. However, if you revoke this permission, you will no longer be allowed to participate in the study. Also, even after your participation in the study ends, FNM and Medtronic may continue to use and disclose the health information they obtained during the study as described in this document.

WHAT ARE MY RIGHTS AS A STUDY PARTICIPANT?

Your participation in this study is entirely voluntary. You are free to not take part or to withdraw the consent for participation in this research study at any time without affecting your medical care. This will not jeopardize future medical care or possible involvement in other research studies. You are free to seek care from a doctor of your choice at any time. If you withdraw or do not take part in the study, you will continue to receive care. Your doctor may remove you from this study at any time if he deems it appropriate. The study sponsor may remove you from the study at any time for any reason without regard to your consent. You will be told about any significant new findings that may relate to your willingness to continue participation in the study. If you decide to withdraw from the study, contact your study doctor in writing and let him/her know that you are withdrawing from the study. The study doctor’s address is:Dr. _________________INSERT ADDRESSINSERT ADDRESS INSERT ADDRESS

ARE THERE OTHER TREATMENT OPTIONS?

You are encouraged to try any alternative treatments that you consider reasonable prior to agreeing to take part in this study. Standard treatment for people with mild Alzheimer’s disease is to receive cholinesterase inhibitors, such as donepezil, rivastigmine, or galantamine. Another drug, memantine, also is used to treat Alzheimer’s disease, but in people who have moderate to severe Alzheimer’s disease only. As you have been diagnosed with mild Alzheimer’s disease,


memantine would not normally be given to you, but you should be aware that it is available if your condition worsens. Medications for the treatment of Alzheimer’s disease are used to treat symptoms and do not cure the disease.

WHAT ARE THE COSTS (PAYMENTS) ASSOCIATED WITH THIS STUDY?

You will not be paid to be part of this study, however, you will be reimbursed for your time and travel expenses at a rate of $200 for each study visit. All equipment and procedures related to the study will be provided without any cost to you. You are responsible for all other costs (including co-pays and deductibles) that are part of your usual medical care and that would have been incurred regardless of your enrollment in the study. If you are unsure of what procedures and tests are included in this, please ask your study doctor before you agree to take part.

If you become ill or are physically injured as a result of participation in this study, medical treatment will be provided. The reasonable costs of such treatment may be covered by your health insurance for any injury or illness that is directly a result of participation in this study. If there is a problem with your device or leads (wires), you will be entitled to the standard product warranty. FNM will not cover the cost of injuries to the extent that they are caused by your negligence, or that of the hospital or study doctor, the natural progression of an underlying or pre-existing condition, or events that would have been expected form the standard treatment using current approved therapies of your condition. If you need a new device or lead after the study is completed, FNM will not provide the new device(s) to you free of charge. In no way does signing this consent form waive your legal rights nor does it relieve the investigators, sponsors or involved institutions from their legal and professional responsibilities.

Commercial InterestsThe study sponsor and other researchers and licensees may patent (copyright) or sell discoveries based on their research. The study sponsor and scientists and licensees may receive money from these activities. There are no plans to pay you or give you a personal financial interest in any products that may be developed from your procedure or information you provide. There are no plans for you to obtain or gain any financial interest in the research.

Device RecoveryIn the event of your death, your doctor will seek copies of your medical records regarding your death. This may include emergency room records and hospital records. This information will be used for study purposes and will be kept confidential. Your family may be asked to allow the removal of the device, the leads and surrounding tissue, if necessary, for evaluation. Your family will not be charged for this procedure. If your family objects to the removal and requests that it not be done, your family’s wishes will be honored.

WHAT IF I HAVE QUESTION OR PROBLEMS?

If you have any general questions about the study, or if you suffer any side effects or other injuries during the study, please call one of the doctors in charge of this study, Dr. __________ at (xxx) xxx-xxxx.


If you have any questions about your rights as a research participant, please call ___________, Chair of the Institutional Review Board/Ethics Committee at (xxx) xxx-xxxx. This person is not involved with the research project in any way and calling him/her will not affect your participation in the study. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by US law. This web site will not include information that will identify you. At most, the web site will include a summary of the results. You can search this web site at any time.


http://www.ClinicalTrials.gov/

STATEMENT OF CONSENT

I have read and fully understand the consent form. I have had the opportunity to discuss this study and my questions have been answered to my satisfaction. I sign it freely and voluntarily and willingly agree to take part in this investigation. I consent to take part in the study with the understanding I may withdraw at any time without affecting my medical care. I have received a signed copy of this consent form.

_________________________ ______________________ ____________Patient’s Name (Please Print) Patient’s Signature Date

Caregiver Consent

I agree, as caregiver, to attend and assist with all study appointments as required by the protocol. I understand that I will be asked questions about the subject which will be a part of the subject’s assessment and data collection for this study. I have read and fully understand the consent form. I have had the opportunity to discuss this study and my questions have been answered to my satisfaction. I sign it freely and voluntarily and willingly agree to be involved in this subject’s study visits. I consent to take part in the study with the understanding I may withdraw at any time without affecting the subject’s medical care. I have received a signed copy of this consent form..

_________________________ ___________________________Caregiver Name Signature (Please Print)

________________________ ______________________Relationship to Participant Date

Surrogate Consent

I have been part of the discussion of this study with the above-named participant and confirm that the study has been presented in what appears to be a fair manner. All questions have been answered and I believe that consent has been obtained appropriately. I agree that the above-named participant has voluntarily consented to take part in this study. I agree that in the event the above-named participant is determined to medically no longer be capable of providing continued consent for their care that I will assist with decision making on behalf of the subject, under assent, following their known wishes and/or in their best interest.

_________________________ ___________________________

Surrogate Name Signature ____________________


(Please Print)

________________________ ______________________

Relationship to Participant Date

I confirm that I have explained the nature and purpose of the study to the subject named above. I have answered all questions.

_________________________ ______________________ _____________Name of Person Signature DateObtaining Consent


Documents

(Letterhead) - advancestudy.files.wordpress.com€¦ · Web viewBASELINE INFORMED CONSENT FOR RESEARCH. CONSENT FOR PARTICIPATION IN A STUDY TITLED: ADvance: A 12-month double-blinded,