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A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease
ISRCTN ISRCTN96337233
DOI 10.1186/ISRCTN96337233
ClinicalTrials.gov identifier
EudraCT number
Public title A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease
Scientific title
Acronym AD2000
Serial number at source N/A
Study hypothesis To assess the efficacy and safety of donepezil and aspirin in Alzheimer's Disease.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Alzheimer's disease
Participants - inclusion criteria 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
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/01/2000
Anticipated end date 01/01/2004
Status of trial Completed
Patient information material
Target number of participants 310
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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.
Sources of funding West Midlands NHS Research & Development Executive (UK)
Trial website http://www.ad2000.bham.ac.uk/
Publications Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15220031
2. http://www.ncbi.nlm.nih.gov/pubmed/18068522
Contact name Prof  Richard  Gray
  Address University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2RR
  Country United Kingdom
  Tel +44 (0)121 415 9100
  Fax +44 (0)121 687 2313
  Email r.gray@bham.ac.uk
Sponsor West Midlands NHS Research & Development Executive (UK)
  Address Bartholomew House
142 Hagley Road
  City/town Birmingham
  Zip/Postcode B16 9PA
  Country United Kingdom
  Sponsor website: http://www.doh.gov.uk/research/wmro/new.htm
Date applied 06/11/2002
Last edited 16/10/2009
Date ISRCTN assigned 06/11/2002
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