BACKGROUND:African Americans have a higher incidence and prevalence of Alzheimer's disease (AD) than whites but have been underrepresented in clinical trials, including studies of cholinesterase inhibitors. PURPOSE: The purpose of this 12-week, open-label study was to evaluate the efficacy and safety of donepezil in African Americans with mild-to-moderate AD. METHODS:Efficacy was assessed via the Mini-Mental State Examination (MMSE), Clinician's Interview-Based Impression of Change-Plus interview with the patient and caregiver (CIBIC-Plus) and Fuld Object Memory Evaluation (FOME), a measure that has been validated for use with elderly African Americans. RESULTS: Significant improvements were observed in cognition (MMSE), global function (CIBIC-Plus) and memory (all four subscales of the FOME). Donepezil was well tolerated; 51% of patients experienced adverse events, most commonly diarrhea (5.6%), hypertension (5.6%) and urinary tract infection (4.8%). CONCLUSIONS: These results suggest that donepezil is effective and safe in treating African Americans with mild-to-moderate AD, and support the value of FOME in assessing efficacy in AD trials in diverse populations.
RCT Entities:
BACKGROUND: African Americans have a higher incidence and prevalence of Alzheimer's disease (AD) than whites but have been underrepresented in clinical trials, including studies of cholinesterase inhibitors. PURPOSE: The purpose of this 12-week, open-label study was to evaluate the efficacy and safety of donepezil in African Americans with mild-to-moderate AD. METHODS: Efficacy was assessed via the Mini-Mental State Examination (MMSE), Clinician's Interview-Based Impression of Change-Plus interview with the patient and caregiver (CIBIC-Plus) and Fuld Object Memory Evaluation (FOME), a measure that has been validated for use with elderly African Americans. RESULTS: Significant improvements were observed in cognition (MMSE), global function (CIBIC-Plus) and memory (all four subscales of the FOME). Donepezil was well tolerated; 51% of patients experienced adverse events, most commonly diarrhea (5.6%), hypertension (5.6%) and urinary tract infection (4.8%). CONCLUSIONS: These results suggest that donepezil is effective and safe in treating African Americans with mild-to-moderate AD, and support the value of FOME in assessing efficacy in AD trials in diverse populations.
Authors: J T Olin; L S Schneider; R S Doody; C M Clark; S H Ferris; J C Morris; B Reisberg; F A Schmitt Journal: J Geriatr Psychiatry Neurol Date: 1996-10 Impact factor: 2.680
Authors: Oscar L Lopez; Joan A Mackell; Yijun Sun; Laurent M Kassalow; Yikang Xu; Thomas McRae; Honglan Li Journal: J Natl Med Assoc Date: 2008-11 Impact factor: 1.798
Authors: Luis Felipe José Ravic de Miranda; Marilourdes do Amaral Barbosa; Patrícia Regina Henrique Peles; Patrícia Hilar Pôças; Pedro Augusto Lopes Tito; Rafael de Oliveira Matoso; Thiago Oliveira Lemos de Lima; Edgar Nunes de Moraes; Paulo Caramelli Journal: Dement Neuropsychol Date: 2013 Apr-Jun