| Abstract | OBJECTIVE: This 132-week, open-label extension study assessed the long-term efficacy and safety of donepezil in 579 patients with mild to moderate Alzheimer's disease (AD) who had previously participated in a 24-week double-blind study of 5 or 10 mg/day donepezil vs placebo. METHOD: Patients enrolled in the present study had a 6-week single-blind placebo washout period followed by treatment with donepezil 5 mg/day for 6 weeks with an optional increase in dosage to 10 mg/day between weeks 6 and 32. RESULTS: After 6 weeks of open-label treatment with donepezil 5 mg/day, mean Alzheimer's Disease Assessment Scale -- cognitive subscale scores (ADAS-cog) improved by approximately two points, while after 12 weeks of open-label treatment (with a majority of patients receiving 10 mg/day), the mean ADAS-cog score was 1 point better than the score at the end of the placebo washout period. Scores then declined gradually over the remainder of the study. Mean changes in Clinical Dementia Rating-Sum of Boxes scores showed slight improvement over the first 12 weeks of open-label treatment and then slowly declined for the remainder of the study period. Donepezil was well tolerated over the entire 162-week study period. Overall, 85% of patients experienced at least one adverse event (AE). The most common included diarrhoea (12%), nausea (11%), infection (11%) and accidental injury (10%). Some patients discontinued the study due to AEs (15%). CONCLUSIONS: These results support the conclusion that donepezil is safe and effective for the long-term treatment of patients with mild to moderate AD. |
| Authors | A Burns, S Gauthier, C Perdomo
(Affiliation: University of Manchster, Manchester, UK. alistair.burns at manchester.ac.uk)
|
| Journal | International journal of geriatric psychiatry
(Int J Geriatr Psychiatry)
Vol. 22
Issue 8
Pg. 806-12
(Aug 2007)
ISSN: 0885-6230 England |
| PMID | 17199235
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Indans
- Nootropic Agents
- Piperidines
- donepezil
|
| Topics |
- Aged
- Aged, 80 and over
- Alzheimer Disease
(diagnosis, drug therapy, psychology)
- Dose-Response Relationship, Drug
- Female
- Follow-Up Studies
- Humans
- Indans
(adverse effects, therapeutic use)
- Long-Term Care
- Male
- Middle Aged
- Neuropsychological Tests
- Nootropic Agents
(adverse effects, therapeutic use)
- Piperidines
(adverse effects, therapeutic use)
- Single-Blind Method
- Treatment Outcome
|
