By Ed Susman
CHICAGO -- July 31, 2008 -- Hispanic patients diagnosed with mild to moderate Alzheimer's disease appear to respond to donepezil therapy as well as other populations, researchers reported here at the 2008 International Conference on Alzheimer's Disease (ICAD).
"The cognitive improvement and safety results from this open-label study are consistent with those reported for donepezil in the general population," said Oscar L. Lopez, MD, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
"Increased awareness of Alzheimer's disease in the Hispanic population will help more Hispanics with Alzheimer's disease to benefit from early diagnosis and effective treatment," Dr. Lopez said at his poster presentation on July 30.
In the 4-week trial, Dr. Lopez and colleagues recruited 105 patients who were self-identified as Hispanic.
Patients were an average of 68.6 years old, about 8 to 10 years younger than most populations in Alzheimer's disease studies, Dr. Lopez said. Patients had a Mini Mental State Examination (MMSE) score between 10 and 26, and the mean score in this study was 22, Dr. Lopez said.
After 12 weeks of treatment with donepezil, the average improvement in the MMSE among patients was 2 points, a significant change (P < .0001).
Patients had a 2- to 3-point improvement in the Neuropsychiatric Inventory (NPI) test, an assessment tool that measures behavioural disturbances commonly occurring in patients with dementia. Those increases from baseline were also significant at both the 6- and 12-week assessments, Dr. Lopez said.
Two cases (1.9%) of serious adverse events were considered to be possibly associated with the treatment. There were no deaths, reported Dr. Lopez.
"A significant number of Hispanics with Alzheimer's disease remain undiagnosed and untreated," he said, "and Hispanic participation in Alzheimer's disease clinical trials is historically low."
"The present study, Evaluating Aricept Treatment in Hispanics (EARTH), is the first sponsor-initiated donepezil clinical trial conducted solely in the Hispanic Alzheimer's disease population," Dr. Lopez added.
Funding for this study was provided by Eisai Inc. and Pfizer Inc.
[Presentation title: Effectiveness and Safety of Donepezil in Hispanic Patients With Mild to Moderate Alzheimer's Disease: A 12-Week Open-Label Study. Abstract P4-382]
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