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

Not Applicable
Completed
Conditions
Alzheimer's disease
Nervous System Diseases
Registration Number
ISRCTN96337233
Lead Sponsor
West Midlands NHS Research & Development Executive (UK)
Brief Summary

2004 Results article in http://www.ncbi.nlm.nih.gov/pubmed/15220031 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18068522

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
310
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

Exclusion Criteria

Not provided at time of registration

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> 1. Cognition (assessed with the mini-mental state examination [MMSE])<br> 2. Functional ability (assessed with the Bristol activities of daily living scale [BADLS])<br><br> Patients were assessed at 12-week intervals in the first year and once each year thereafter.<br>
Secondary Outcome Measures
NameTimeMethod
<br> 1. Time to formal domiciliary or institutional care<br> 2. Progress of disability<br> 3. Behavioural symptoms<br> 4. Caregiver wellbeing<br> 5. Care time<br><br> Patients were assessed at 12-week intervals in the first year and once each year thereafter.<br>
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