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From the Department of Neurology at the State University of New York at Stony Brook. L.E.E. is currently affiliated with Ortho-McNeil Pharmaceutical.
Address correspondence and reprint requests to Dr. Lauren Krupp, Department of Neurology, State University of New York at Stony Brook, HSC T12-020, Stony Brook, NY 11794-8121; e-mail: lauren.krupp{at}stonybrook.edu
Objective: To determine the effect of donepezil in treating memory and cognitive dysfunction in multiple sclerosis (MS).
Methods: This single-center double-blind placebo-controlled clinical trial evaluated 69 MS patients with cognitive impairment who were randomly assigned to receive a 24-week treatment course of either donepezil (10 mg daily) or placebo. Patients underwent neuropsychological assessment at baseline and after 24 weeks of treatment. The primary outcome was change in verbal learning and memory on the Selective Reminding Test (SRT). Secondary outcomes included other tests of cognitive function, patient-reported change in memory, and clinician-reported impression of cognitive change.
Results: Donepezil-treated patients showed significant improvement in memory performance on the SRT compared to placebo (p = 0.043). The benefit of donepezil remained significant after controlling for various covariates including age, Expanded Disability Status Scale, baseline SRT score, reading ability, MS subtype, and sex. Donepezil-treated patients did not show significant improvements on other cognitive tests, but were more than twice as likely to report memory improvement than those in the placebo group (p = 0.006). The clinician also reported cognitive improvement in almost twice as many donepezil vs placebo patients (p = 0.036). No serious adverse events related to study medication occurred, although more donepezil (34.3%) than placebo (8.8%) subjects reported unusual/abnormal dreams (p = 0.010).
Conclusions: Donepezil improved memory in MS patients with initial cognitive impairment in a single center clinical trial. A larger multicenter investigation of donepezil in MS is warranted in order to more definitively assess the efficacy of this intervention.
Received February 18, 2004. Accepted in final form July 1, 2004.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the November 9 issue to find the title link for this article.
See also page 1552
Presented in part at the 2003 and 2004 annual meetings of the American Academy of Neurology.
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