Treatment response to Aricept® (donepezil hydrochloride) not predicted by Apolipoprotein E4 genotype or gender

WASHINGTON, D.C. 11 July, 2000 -- Aricept® (donepezil hydrochloride) demonstrated beneficial effects on cognition and global function over the course of one year in a double-blind, placebo-controlled, multinational study in patients with mild to moderate Alzheimer's disease (AD). In this study, treatment response was not predicted by Apolipoprotein E4 (ApoE4) genotype and/or gender, according to data presented today at the World Alzheimer Congress in Washington D.C.

ApoE is a lipoprotein that carries cholesterol in the blood. The exact role the ApoE4 allele plays in the pathogenesis of AD or in the memory decline of cognitively impaired elderly is unclear presently. Furthermore, much of the evidence concerning a correlation between ApoE4 copy number and the pathological features of AD (e.g. neuronal plaque density and the appearance of neurofibrillary tangles) is contradictory. It has been suggested that patients carrying an ApoE4 allele may have a more severe cholinergic deficit than those who do not.

"The reports of associations between ApoE4 genotype, gender and response to cholinesterase inhibitor therapy in AD patients are conflicting. In this recently completed study, a secondary analysis showed that the treatment response to ARICEPT®, a cholinesterase inhibitor, was not predicted by ApoE4 genotype and/or gender in patients with mild to moderate AD," says Hilkka Soininen, M.D., Ph.D., University of Kuopio, Kuopio, Finland.

This one-year multinational, double-blind, placebo-controlled study enrolled 286 patients with mild to moderate AD from 28 sites in five Northern European countries (Denmark, Finland, Norway, Sweden and The Netherlands). Patients were randomized to receive either ARICEPT® (n=142; 5 mg/day for 28 days, and then 10 mg/day) or placebo (n=144) for one year. The mean age of the patients enrolled in the study was 72.5 (range: 49-88 years).

Outcomes measures included evaluation of global function (the Gottf

Contact: Celeste Torello, Pfizer Inc.
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