Archief Roodbont

A substantial proportion of patients with the amnestic (memory-impairment) subtype of mild cognitive impairment (MCI) eventually progresses to Alzheimer disease. In this industry-sponsored study, researchers examined the effect of donepezil — approved for use in Alzheimer disease but not MCI — in 821 patients with amnestic MCI.

Patients were randomized to 48-week courses of donepezil or placebo. The investigators specified that donepezil would not be considered superior to placebo unless it was favored in scores on both of two primary endpoints (the ADAS-cog, which evaluates cognition, and the CDR-SB, which evaluates cognition and function).

At 48 weeks, mean ADAS-cog scores were significantly improved in the donepezil group compared with the placebo group, but the difference was only 1 point on an 89-point scale. CDR-SB scores did not differ in the two groups. For eight secondary endpoints (representing various other standardized assessment tools), two favored donepezil and six did not differ between groups. Adverse events possibly or probably related to treatment were significantly more common with donepezil than with placebo (47% vs. 25%).

Comment: In this study, donepezil was not superior to placebo, according to the primary efficacy endpoint selected by the researchers. Clinicians should not prescribe donepezil for patients with mild cognitive impairment.

— Allan S. Brett, MD

Published in Journal Watch General Medicine May 14, 2009