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• W2058372238 abstract "Rates of Alzheimer's disease (AD) are markedly higher among African Americans than among Caucasians. Additionally, African Americans tend to be diagnosed and institutionalized during the later stages of AD. Culturally sensitive evaluations, such as the Fuld Object Memory Evaluation (FOME), may improve accuracy in identifying patients at earlier stages of the disease. While donepezil has consistently demonstrated safety and efficacy in clinical studies, it has not been specifically evaluated in African American patients. To evaluate the efficacy and safety of donepezil in African Americans with mild to moderate Alzheimer's disease (AD). African American patients aged at least 50 years with a clinical diagnosis of AD and a Mini-Mental State Examination (MMSE) score of 10 to 26 inclusive received 12 weeks of open-label donepezil treatment. Efficacy was assessed via FOME, MMSE, and Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus). The FOME was chosen because it is insensitive to education and hearing ability and has been validated in elderly African Americans. (Wall JR, et al. Clin Gerontol. 1998;19:39-49. Mast BT, et al. Clin Neuropsychol. 2001;15:196-202. Summers JD, et al. Clin Gerontol. 1995;15:21-34.) Scores were analyzed for the intent-to-treat population at Weeks 4, 8, and 12, and at end point with the last observation carried forward (LOCF). Safety was assessed by adverse events, reasons for discontinuation, and laboratory results. A total of 125 patients met inclusion criteria and received treatment; 119 patients were included in the intent-to-treat population. Mean FOME storage, FOME retrieval, and MMSE scores were significantly improved from baseline at each evaluation (P<0.05) and in the LOCF analysis (FOME retrieval and MMSE, P<0.0001). Mean CIBIC-Plus scores were significantly improved at end point compared with baseline (P<0.0001). The most common adverse events were diarrhea and hypertension. Five patients (4.0%) discontinued due to adverse events. Laboratory results were unremarkable. Donepezil demonstrated significant improvements in measures of memory, cognition, and global function in African Americans with AD. These results indicate that donepezil is safe and effective for AD treatment in the African American population." @default.
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• W2058372238 date "2005-07-01" @default.
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• W2058372238 title "[P-205]: Safety and efficacy of donepezil in a 12-week, open-label trial in African Americans with mild to moderate Alzheimer's disease" @default.
• W2058372238 doi "https://doi.org/10.1016/j.jalz.2005.06.263" @default.
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