SAN DIEGO – Donepezil is safe and effective in African Americans with mild to moderate Alzheimer's disease, a 12-week open-label study demonstrated.
The finding is important because African Americans are underrepresented in clinical trials even though they have a higher risk of developing Alzheimer's disease, compared with whites, Patrick Griffith, M.D., said during a poster session at the annual meeting of the American Association for Geriatric Psychiatry.
In addition, this is the first Alzheimer's trial to use the Fuld Object Memory Evaluation (FOME), which is thought to provide a culturally unbiased evaluation of memory. “The test has been validated in African Americans, and it operates independent of educational level or [social background],” Dr. Griffith, chief of the division of neurology at Morehouse School of Medicine, Atlanta, said in an interview. “It relies on touch and vision. We may have a measuring tool for future clinical trials that will avoid previous reports of educational or cultural bias.”
He added that the FOME was designed for elders who may have problems with hearing or attention.
Dr. Griffith and his associates enrolled 125 community-dwelling African Americans aged 51–98 from 30 sites in the United States with a clinical diagnosis of mild to moderate Alzheimer's disease and Mini-Mental State Examination (MMSE) scores of 10–26. The patients received donepezil (Aricept) 5 mg/day at the conclusion of their baseline visit; the dose was increased to 10 mg/day after 4 weeks–according to clinician judgment.
At weeks 4, 8, and 12, the investigators administered the FOME, the MMSE, and the Clinician Interview-Based Impression of Change with Caregiver Input (CIBIC-plus).
From baseline to week 12, patients demonstrated significant improvement on the FOME storage and retrieval scores, the MMSE scores, and the CIBIC-plus scores.
The most common treatment-emergent adverse events were diarrhea, hypertension, and urinary tract infection, and the incidences were similar to those reported previously in patients with mild to moderate Alzheimer's. Lab results were unremarkable.
Pfizer Inc., which manufactures donepezil, supported the study.