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. Copyright © 2007 John Wiley & Sons, Ltd.