Condition category
Nervous System Diseases
Date applied
06/11/2002
Date assigned
06/11/2002
Last edited
16/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ad2000.bham.ac.uk/

Contact information

Type

Scientific

Primary contact

Prof Richard Gray

ORCID ID

Contact details

University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom
+44 (0)121 415 9100
r.gray@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

AD2000

Study hypothesis

To assess the efficacy and safety of donepezil and aspirin in Alzheimer's Disease.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Applicable

Drug names

Donepezil, aspirin

Primary outcome measures

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 trial start date

01/01/2000

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

310

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

United Kingdom

Trial participating centre

University of Birmingham Clinical Trials Unit
Birmingham
B15 2RR
United Kingdom

Sponsor information

Organisation

West Midlands NHS Research & Development Executive (UK)

Sponsor details

Bartholomew House
142 Hagley Road
Birmingham
B16 9PA
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

West Midlands NHS Research & Development Executive (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15220031
2. http://www.ncbi.nlm.nih.gov/pubmed/18068522

Publication citations

  1. Courtney C, Farrell D, Gray R, Hills R, Lynch L, Sellwood E, Edwards S, Hardyman W, Raftery J, Crome P, Lendon C, Shaw H, Bentham P, , Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial., Lancet, 2004, 363, 9427, 2105-2115, doi: 10.1016/S0140-6736(04)16499-4.

  2. , Bentham P, Gray R, Sellwood E, Hills R, Crome P, Raftery J, Aspirin in Alzheimer's disease (AD2000): a randomised open-label trial., Lancet Neurol, 2008, 7, 1, 41-49, doi: 10.1016/S1474-4422(07)70293-4.

Additional files

Editorial Notes