THURSDAY, Oct. 4 (HealthDay News) -- In treating agitation in patients with Alzheimer disease, donepezil is no more effective than placebo, according to a report published in the Oct. 4 issue of the New England Journal of Medicine.
Robert J. Howard, of King's College London in the U.K., and colleagues randomly assigned 272 patients who failed to respond to a brief psychosocial treatment program to receive either donepezil or placebo for 12 weeks.
The researchers found no significant group differences in scores on the Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory, the Neuropsychiatric Inventory Caregiver Distress Scale or the Clinician's Global Impression of Change. Only 19.5 percent of the donepezil group and 20.4 percent of the placebo group had a reduction of more than 30 percent on the CMAI score.
"The results of the
trial reduce the cumulative evidence that cholinesterase inhibitors are an efficacious treatment for neuropsychiatric symptoms, or at least for agitation," states the author of an accompanying editorial. "Some trials suggest that other neuropsychiatric symptoms may be more responsive to treatment with cholinesterase inhibitors. As Howard and colleagues indicate, agitation may not represent a homogenous clinical phenomenon, and this is a potential limitation of the trial."
Janssen provided the risperidone and Eisai UK provided the donepezil for this study.
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