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Donepezil HCl (E2020) Maintains Functional Brain Activity in Patients With Alzheimer Disease

Results of a 24-Week, Double-Blind, Placebo-Controlled Study

Received October 2, 2001; revised May 28, October 28, 2002; accepted October 28, 2002. From the Wesley Woods Center at Emory University, Atlanta, GA (LT); Eisai Inc, Teaneck, NJ, U.S.A. (JI,CP,RDP); Pfizer, Inc., New York, NY (PJT); and Emory University School of Medicine, Atlanta, GA (JRV,RDJ,JMH). Address correspondence to Dr. Tune, Wesley Woods Center at Emory University, Atlanta, GA. e-mail: ltune{at}emory.edu

OBJECTIVE: The authors evaluated the effects of donepezil (10 mg/day) versus placebo on brain glucose metabolism. METHODS: This was a randomized, double-blind, parallel-group, 24-week pilot study in 28 patients with mild-to-moderate Alzheimer disease (AD). Functional brain activity was quantified by measuring average glucose metabolism in an axial brain slice and regional brain glucose metabolism using positron emission tomography. RESULTS: At Week 24, relative to the pons metabolic rate, mean brain glucose metabolism in an axial slice at the level of the striatum was maintained within 0.5% of mean baseline levels for donepezil-treated patients, whereas it declined by an average of 10.4% in placebo-treated patients. This observation was confirmed by an analysis of differences in the mean slopes of glucose metabolism in the striatal slice in donepezil- and placebo-treated patients during the 24-week period. Significant treatment differences at Week 24 favoring donepezil for the mean percentage change from baseline in regional brain glucose metabolism were observed in four predefined regions of interest: the right parietal lobe 1, left temporal lobe 2, right frontal lobe 2, and left frontal lobe 2. CONCLUSION: Placebo-treated patients with AD show a decline in functional brain activity, relative to the pons, in several regions, and treatment with donepezil may slow this decline.

Key Words: Alzheimer's Disease • PET • Donepezil • Cholinesterase Inhibitors

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