Dementias and Neurodegenerative Diseases Research Network 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 Based at St Nicholas Hospital and Institute for Ageing and Health in Newcastle Team members also in Tees, Esk and Wear Valley NHS Trust and County Durham and Darlington NHS Trust www.dendron.org.uk Where we fit in… Supports facilities for research Commissions and funds NHS and social care research (e.g. Biomedical Research Units) Trains and develops researchers Cancer Dementia and Neurodegenerative Diseases Diabetes Medicines for Children Mental Health Stroke Primary Care Comprehensive Dementias and Neurodegenerative Diseases Research Network Research arm of NHS Facilitate studies for prevention, diagnosis, treatment • Flexible • Experienced • Trained research support www.dendron.org.uk Dementias and Neurodegenerative Diseases Research Network Range of studies in dementia – Clinical Trial of an Investigational Medicinal Product (CTIMPs) • DOMINO • HTA-SADD • MAIN-AD • Scarlet Road • Servier Observational, Investigative and Neuropsychiatric Studies • DEMO-POD • Newcastle Cognitive Fluctuation Scale Imaging Studies • SUSPECTED-AD • CATFieLD Other interventional studies, costs of dementia and information use • PRoVIDe • Give and Take 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 www.dendron.org.uk Published NEJM 8th March 2012 11 42 Direction of improvement 10 40 9 38 8 36 BADLS sMMSE 7 6 5 34 32 30 4 28 3 2 26 placebo Direction of improvement memantine 1 24 donepezil donepezil and memantine 0 0 6 18 30 Visit Week 22 52 0 6 18 30 Visit Week 52 Servier Study DeNDRoN 076 Patient group - Alzheimer’s disease PI – Dr Andrew Byrne Recruiting across the North East NTW, TEWV, Gateshead, and Northumbria Trusts • 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 SCARLET ROAD STUDY DeNDRoN 055 Patient group – MCI (Prodromal Alzheimer’s) PI – Dr Bob Barber Recruiting across the North East NTW, TEWV, Gateshead, and Northumbria Trusts 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 Impairment in People with Dementia Patient group – any dementia, mild, moderate or severe Research sites – TEWV, NTW, and Northumbria PIs – Helen Robinson, Bob Barber, and Julian Hughes recruiting across the North East • 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 Brains for Dementia Research Brains for Dementia Research (BDR) • For anyone over 65 with a diagnosis of dementia, or controls • Annual visit, collect clinical data Brain tissue stored in the Newcastle Brain Tissue Resource 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 www.dendron.org.uk Patient List Disease Groups VaD/AD VaD MCI Alzheimer’s disease PSP FTD Parkinson’s disease PDD Dementia with Lewy bodies DLB Parkinson’s disease dementia AD Progressive supranuclear palsy Fronto-Temporal dementia Vascular dementia Mixed Vascular and Alzheimer’s dementia Mild Cognitive Impairment PD Over 550 patients – half of dementia patients have joined a study Clinician and Researcher Involvement • Refer to the Patient List • Refer to an existing study • Register interest in a study recruiting elsewhere • Develop a research proposal www.dendron.org.uk Public / Patient Involvement Panel The 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 www.dendron.org.uk