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April 4, 2003
Severe Alzheimer's disease (AD) patients treated with Aricept ® (donepezil HCl tablets) showed significant improvement in global function, cognition, behavior, and activities of daily living versus placebo, according to new data from a subset analysis of the Moderate to Severe Alzheimer's Disease Study (MSAD), previously published in Neurology in August 2001.
These data, which were presented at the American Academy of Neurology (AAN) 55th Annual Meeting, demonstrated that Aricept ® provided significant benefits versus placebo in everyday tasks, as well as in behavioral symptoms associated with AD. These findings suggest Aricept ® may provide important benefits for patients with advanced AD.
"The results of this trial indicate that the benefits of Aricept ®, which have been reported in clinical trials of mild to moderate AD, may also extend into the severe AD stage," said Howard Feldman, MD, UBC Hospital, Clinic for Alzheimer's Disease and Related Disorders, Vancouver, British Columbia. "These findings are meaningful for patients when treatment is started even in the later stage of the disease."
In this analysis, 145 patients with severe Alzheimer's disease were randomized to receive either Aricept ® (n=72), 5 mg once daily for the first 28 days and 10 mg once daily thereafter based on the clinicians' judgment, or placebo (n=73). Baseline demographics, including age and sex, were similar between the Aricept ® and placebo groups.
The study enrolled patients residing in the community or in assisted living settings. Patients requiring total nursing care were ineligible. The mean standardized Mini/Mental State Examination (sMMSE) score at baseline was 9.0 for the Aricept ® group and 8.9 for the placebo group. Patients were assessed at Weeks 4, 8, 12, 18, and 24. Consistent benefits were found for Aricept ® across the full range of measures of patient outcomes – global function, cognition, behavior, and activities of daily living .
Aricept ®-treated patients showed statistically significant improvement or remained at or near baseline throughout the study on measure of global function, while placebo-treated patients showed functional decline.
Patients showed statistically significant overall cognitive improvement versus placebo, showed statistically significantly less decline compared with placebo-treated patients on activities of daily living, and showed statistically significant overall improvement versus placebo in behavioral disturbances associated with Alzheimer's.
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