A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease

ISRCTN	ISRCTN96337233
DOI	https://doi.org/10.1186/ISRCTN96337233
Secondary identifying numbers	N/A

Submission date: 06/11/2002
Registration date: 06/11/2002
Last edited: 28/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Richard Gray
Scientific

University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom

Phone	+44 (0)121 415 9100
Email	r.gray@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease
Study acronym	AD2000
Study hypothesis	To assess the efficacy and safety of donepezil and aspirin in Alzheimer's Disease.
Ethics approval(s)	Not provided at time of registration
Condition	Alzheimer's disease
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Donepezil, aspirin
Primary outcome measure	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 measures	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.
Overall study start date	01/01/2000
Overall study end date	01/01/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	310
Participant 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
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/01/2000
Recruitment end date	01/01/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham Clinical Trials Unit

Birmingham
B15 2RR
United Kingdom

Sponsor information

West Midlands NHS Research & Development Executive (UK)
Government

Bartholomew House
142 Hagley Road
Birmingham
B16 9PA
United Kingdom

Website	http://www.doh.gov.uk/research/wmro/new.htm

Funders

Funder type

Government

West Midlands NHS Research & Development Executive (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/06/2004		Yes	No
Results article		01/01/2008		Yes	No

Editorial Notes

28/10/2022: Internal review.