Safety and efficacy of donepezil in African Americans with mild-to-moderate Alzheimer's disease.
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.


OBJECTIVE
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.
Griffith
Patrick
P
Section of Neurology, Morehouse School of Medicine, Atlanta, GA, USA. pgriffith@mmc.edu
Lichtenberg
Peter
P
Goldman
Robert
R
Payne-Parrish
Jennifer
J
D001741:Black or African American; D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000208:ethnology*; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D000077265:Donepezil; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D010880:Piperidines / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil