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| A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease |
| Source of record | UK Trials |
| ISRCTN | ISRCTN96337233 |
| Date ISRCTN assigned | 06/11/2002 |
| Local reference number(s) | N/A |
| Public title | A reliable assessment of the efficacy and safety of donepezil and aspirin in Alzheimer's Disease |
| Scientific title | |
| Acronym | AD2000 |
| Disease/condition/study domain | Alzheimer's disease |
| Study hypothesis | To assess the efficacy and safety of donepezil and aspirin in Alzheimer's Disease. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | |
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 01/01/2004 |
| Status of trial | Completed |
| 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. |
| Publications | Results in: 1. http://www.ncbi.nlm.nih.gov/pubmed/15220031 2. http://www.ncbi.nlm.nih.gov/pubmed/18068522 |
| Sources of funding | West Midlands NHS Research & Development Executive (UK) |
| Sponsor name | West Midlands NHS Research & Development Executive (UK) |
| Sponsor details | Bartholomew House 142 Hagley Road Birmingham United Kingdom B16 9PA |
| Sponsor website | http://www.doh.gov.uk/research/wmro/new.htm |
| Contact name | Prof Richard Gray |
| Contact details | University of Birmingham Clinical Trials Unit University of Birmingham Park Grange 1 Somerset Road Edgbaston Birmingham United Kingdom B15 2RR |
| Contact telephone | +44 (0)121 415 9100 |
| Contact fax | +44 (0)121 687 2313 |
| Contact email | r.gray@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN96337233 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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