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Vascular DementiaApril 30, 2003
The leading Alzheimer treatment, Aricept (donepezil HCl tablets), may also benefit patients with vascular dementia (VaD), according to a study analysis presented at the American Academy of Neurology (AAN) 55th Annual Meeting.
There are no medications approved to treat VaD, which affects approximately 1.3 million Americans. VaD is caused by a single, localized stroke or series of strokes. A supplemental New Drug Application (sNDA) is under review by the U.S. Food and Drug Administration for the treatment of VaD with Aricept. Aricept is indicated for the treatment of mild to moderate AD.
This study analysis presented at AAN compared treated and untreated Alzheimer disease (AD) and VaD patients. In these distinct populations, patients treated with Aricept demonstrated significant improvements in cognition, behavior, and activities of daily living, compared to those receiving placebo. There were important differences in the treatment response between AD and VaD patients. This study suggests that for VaD patients an important measure of treatment success is the improvement of symptoms. Treatment success for AD patients includes improvement, stabilization or a less-than-expected decline.
"Currently, more than 60% of VaD patients are undiagnosed," said Dr. Stephen Sanlloway, director of neurology and the memory disorders program and associate professor of clinical eurosciences at Brown Medical School, Providence, Rhode Island. "This analysis supports the need for physicians to diagnose, as well as treat, their VaD patients. As the population ages and more people are at risk for VaD, treatment will become more critical than ever to address this growing health care issue."
The research is a post-hoc analysis of 12 prospective studies, including two 24-week, double-blind, randomized, placebo-controlled studies of 1219 patients with probable or possible VaD and 10 studies of 2376 patients with probable AD. VaD patients were eligible for enrollment based upon research criteria developed NINDS-AIREN (National Institute of Neurological Disorders and Stroke-Associate Internationale pour la Recherche et l'Enseignment en Neurosciences).
Patients were randomized to receive Aricept 5 mg/day (VaD patients n= 406; AD patients n=821), Aricept 10 mg/day (VaD patients n=421; AD patients n=662), or placebo (VaD patients n=392; AD patients n=893). Patients in this study were evaluated using the Clinician's Interview-based Impression of Change-Plus version (CIBIC-plus). These analyses are based on observed cases of patients who had a final evaluation at week 24.
A greater proportion of Aricept-treated patients showed improvement in cognition, behavior, and activities of daily living compared to those taking placebo, both in VaD (placebo, 29%; Aricept 5 mg/day, 41%, p=0.003; Aricept 10 mg/day, 33%, p=0.072; overall treatment, p=0.001), and in AD (placebo, 16%; Aricept 5 mg/day, 31%, p<0.0001; Aricept 10 mg/day, 27%, p<0.0001; overall treatment, p<0.0001).
Fewer Aricept-treated patients compared to those on placebo showed decline, both in VaD (placebo, 30%; Aricept 5 mg/day, 21%; Aricept 10 mg/day, 27%), and in AD (placebo, 49%; Aricept 5 mg/day, 37%; Aricept 10 mg/day, 35%). This article was prepared by Pain & Central Nervous System Week editors from staff and other reports.
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