Clinical trials with DeNDRoN in the North East

Dr Margaret Piggott

Data and Communications Manager

www.dendron.nihr.ac.uk/northeast

Dementias and Neurodegenerative Diseases Research Network

www.dendron.org.uk

Team members also in Tees, Esk and Wear Valley NHS Trustand County Durham and Darlington NHS Trust

Based at St Nicholas Hospital and Institute for Ageing and Health in Newcastle

Dementias and Neurodegenerative Diseases Research Network

Where we fit in…

Commissions and funds NHS and social care research

Trains and develops

researchers

Supports facilities for

research (e.g. Biomedical Research Units)

Cancer Dementia and

Neurodegenerative Diseases

Diabetes Medicines for Children

Mental Health Stroke Primary Care Comprehensive

www.dendron.org.uk

Research arm of NHS

Facilitate studies for prevention, diagnosis, treatment

• Flexible

• Experienced

• Trained research support

Dementias and Neurodegenerative Diseases Research Network

Range of studies in dementia –

Imaging Studies

Other interventional studies, costs of dementia and information use

• SUSPECTED-AD• CATFieLD

• PRoVIDe• Give and Take

Clinical Trial of an Investigational Medicinal Product (CTIMPs)

Observational, Investigative and Neuropsychiatric Studies

• DEMO-POD• Newcastle Cognitive

Fluctuation Scale

• DOMINO• HTA-SADD • MAIN-AD• Scarlet Road• Servier

Dementias and Neurodegenerative Diseases Research Network

www.dendron.org.uk

HTA-SADD

• Depression in dementia

• Which antidepressants effective?

• Testing mirtazapine and sertraline

• Double-blind placebo controlled trial, clinical and cost effectiveness

• Sponsored by the Alzheimer’s Society

Recently reported –

No benefit better than placebo

www.dendron.org.uk

• Blinded Placebo controlled trial• Memantine vs Donepezil vs

Both vs Placebo • Severe Alzheimer’s Disease• Follow up for 12 months

Direction of improvement

0

1

2

3

4

5

6

7

8

9

10

11

sMM

SE

0 6 18 30 52

Visit Week

placebo

memantine

donepezil

donepezil and memantine

Direction of improvement

22

24

26

28

30

32

34

36

38

40

42

BA

DLS

0 6 18 30 52

Visit Week

Published NEJM 8th March 2012

• Testing an oral histamine H3 inverse agonist

• Presynaptic H3 receptors inhibit transmitter release - the inverse agonist should remove the inhibition and promote transmitter release

• Inclusion: Moderate Alzheimer’s, MMSE 12-20, stable on 10mg donepezil

Servier Study DeNDRoN Servier Study DeNDRoN 076076Patient group - Alzheimer’s diseasePatient group - Alzheimer’s diseasePI – Dr Andrew Byrne

Recruiting across the North EastNTW, TEWV, Gateshead, and Northumbria Trusts

Patient group – MCI (Prodromal Alzheimer’s)Patient group – MCI (Prodromal Alzheimer’s)

PI – Dr Bob Barber

Recruiting across the North East NTW, TEWV, Gateshead, and Northumbria Trusts

SCARLET ROAD SCARLET ROAD STUDYSTUDY

DeNDRoN 055DeNDRoN 055

Subcutaneous gantenerumab (monoclonal antibody) removes amyloid

2 year study in MCI – reduce risk of converting to dementia?

Inclusion: MMSE >24, age 50-85

PROVIDE - Prevalence of Visual PROVIDE - Prevalence of Visual Impairment in People with DementiaImpairment in People with Dementia  

• 100 community dwelling• 100 care home residents• recruit, consent, MMSE• referred to optometrists• assess visual impairment • how visual problems are managed• recommend interventions to improve eye care 

Patient group – Patient group – any dementia, mild, moderate or severeany dementia, mild, moderate or severeResearch sites – TEWV, NTW, and NorthumbriaPIs – Helen Robinson, Bob Barber, and Julian Hughesrecruiting across the North East

www.dendron.org.uk

BBrains for rains for DDementia ementia RResearchesearch

Brain tissue stored in the Newcastle Brain Tissue Resource

Brains for Dementia Research (BDR) • For anyone over 65 with a diagnosis of

dementia, or controls• Annual visit, collect clinical data

www.dendron.org.uk

DeNDRoN Patient List

Patients use the Patient List to keep informed about studies

DeNDRoN uses the Patient List to recruit quickly to studies

Clinicians use the Patient List to give patients research opportunities

Patient List Disease Groups

Alzheimer’s disease

Parkinson’s disease

Dementia with Lewy bodies

Parkinson’s disease dementia

Fronto-Temporal dementia

Vascular dementia

Mixed Vascular and Alzheimer’s dementia

Progressive supranuclear palsy

Mild Cognitive Impairment

AD

PD

DLB

PDD

FTD

VaD

VaD/AD

PSP

MCI

Over 550 patients – half of dementia patients have joined a study

www.dendron.org.uk

Clinician and Researcher Clinician and Researcher InvolvementInvolvement

• Refer to the Patient ListRefer to the Patient List

• Refer to an existing studyRefer to an existing study

• Register interest in a study Register interest in a study recruiting elsewhererecruiting elsewhere

• Develop a research proposalDevelop a research proposal

www.dendron.org.uk

Public / Patient Involvement PanelPublic / Patient Involvement Panel

The PPI PanelThe PPI Panel brings together patients and carers affected by all the disease groups included for clinical research by DeNDRoN

Can supply quick lay opinion on proposed studies

www.dendron.org.uk

Thank you! Tel: 0191 2232740

www.dendron.org.uk