Alzheimer's disease Nervous System Diseases Alzheimer's disease
Conditions
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 don
Sponsors
West Midlands NHS Research & Development Executive (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Outcome results
None listed