Source: DGNews  |  Posted 3 years ago

By Rachel Parratt

HONG KONG -- March 2, 2008 -- Donepezil (Aricept) showed small but significant improvements in cognition for patients with amnestic mild cognitive impairment (MCI), a condition in which up to 80% of patients progress to Alzheimer's Disease (AD) within 6 years of diagnosis.

Donepezil, a cholinesterase inhibitor, is a treatment for mild, moderate, and severe AD.

A statistically significant difference, measured by the Modified Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) score, was observed between patients treated with donepezil and those given placebo (mean -0.90, standard deviation [SD] 0.37; P = .01) at study endpoint (1 year).

Rachelle Doody, MD, PhD, Professor of Neurology, Department of Neurology, Baylor College of Medicine, Houston, Texas, presented these findings here at the 10th International Hong Kong/Springfield Pan-Asian Symposium on Advances in Alzheimer Therapy (AAT).

Significant differences were also observed for certain patient subjective measures. Scores for Patient Global Assessment favoured donepezil at all time points (P < .03), except for week 4, and scores for the Perceived Deficits Questionnaire (PDQ) favoured donepezil at study endpoint (P = .02).

There were no differences between groups for Clinical Dementia Rating - Sum of Boxes, Symbol Digit Modalities Test, Mini-Mental State Examination score, Digit Span Backward test, Neuropsychiatric Inventory, PDQ for Relatives, and Alzheimer's Disease Cooperative Study Clinical Global Impression of Change - MCI.

This multicentre, double-blind, placebo-controlled, parallel-group study was conducted in 821 patients (aged 45 to 90 years) who were randomised to either donepezil (n = 409) or placebo (n = 412). Patients were exposed to study treatment for a mean of 248 days (SD 120) in the donepezil group and 282 days (SD 100) in the placebo group.

Of the 165 discontinuations in the donepezil group, 72 were due to adverse events. The most frequent treatment-emergent adverse events were diarrhoea (16.4% vs 3.4%, respectively), muscle spasms (13.3% vs 1.8%, respectively), and nausea (9.7% vs 4.4%, respectively).

"Donepezil treatment was associated with a small but significant improvement in cognition, and subjective endpoints suggest that patients with MCI perceived more benefits with donepezil treatment," the authors concluded.

Funding for this study was provided by Eisai Inc. and Pfizer Inc.

[Presentation title: A 1-Year Randomized Controlled Trial of Donepezil in Patients With Mild Cognitive Impairment. Poster 12F]