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ISRCTN
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ISRCTN96337233
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ClinicalTrials.gov identifier
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Public title
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A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease
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Scientific title
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Acronym
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AD2000
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Serial number at source
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N/A
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Study hypothesis
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To assess the efficacy and safety of donepezil and aspirin in Alzheimer's Disease.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Alzheimer's disease
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Participants - inclusion criteria
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1. Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM IV) diagnosis of Alzheimer's disease, with or without evidence of vascular dementia
2. Mild to moderate Alzheimer's disease (Mini Mental State Examination [MMSE] score 10 - 26)
3. No definite contraindication to, or clear indication for, donepezil
4. Not in residential care
5. Regular carer
6. Not have already taken donepezil or any other cholinergic enhancing agent
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/01/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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310
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Interventions
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Patients are randomised to receive donepezil 5 mg or placebo for the first 12 weeks of the trial.
Those who complete 12 weeks of treatment are re-randomised to receive 48 weeks of donepezil or placebo from week 13 onwards, with donepezil dose sub-randomised between 5 and 10 mg.
Eligible patients (those with no clear indication for, or clear indication against, aspirin) are also randomised at entry between 75 mg enteric-coated aspirin daily or aspirin avoidance.
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Primary outcome measure(s)
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1. Cognition (assessed with the mini-mental state examination [MMSE])
2. Functional ability (assessed with the Bristol activities of daily living scale [BADLS])
Patients were assessed at 12-week intervals in the first year and once each year thereafter.
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Secondary outcome measure(s)
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1. Time to formal domiciliary or institutional care
2. Progress of disability
3. Behavioural symptoms
4. Caregiver wellbeing
5. Care time
Patients were assessed at 12-week intervals in the first year and once each year thereafter.
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Sources of funding
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West Midlands NHS Research & Development Executive (UK)
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Trial website
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Publications
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Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15220031
2. http://www.ncbi.nlm.nih.gov/pubmed/18068522
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Contact name
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Prof
Richard
Gray
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Address
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University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2RR
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Country
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United Kingdom
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Tel
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+44 (0)121 415 9100
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Fax
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+44 (0)121 687 2313
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Email
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r.gray@bham.ac.uk
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Sponsor
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West Midlands NHS Research & Development Executive (UK)
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Address
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Bartholomew House
142 Hagley Road
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City/town
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Birmingham
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Zip/Postcode
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B16 9PA
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Country
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United Kingdom
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Sponsor website:
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http://www.doh.gov.uk/research/wmro/new.htm
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Date applied
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06/11/2002
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Last edited
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19/03/2008
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Date ISRCTN assigned
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06/11/2002
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