Neurology 2002;58:1050-1054
© 2002 American Academy of Neurology
Randomized pilot study of nimesulide treatment in Alzheimer’s disease
P. S. Aisen, MD,
J. Schmeidler, PhD and
G. M. Pasinetti, MD PhD
From the Department of Neurology (Dr. Aisen), Georgetown University Medical Center, Washington, DC; and the Department of Psychiatry (Drs. Aisen, Schmeidler, and Pasinetti) and the Neuroinflammation Research Laboratories (Dr. Pasinetti), Department of Psychiatry, Mount Sinai Medical Center, New York, NY.
Address correspondence and reprint requests to Dr. Paul S. Aisen, Department of Neurology, Georgetown University Medical Center, 1 Bles Building, 3800 Reservoir Road, NW, Washington, DC 20007; e-mail: psa{at}georgetown.edu
Background: Nonsteroidal anti-inflammatory drugs (NSAID) may be useful in the treatment of AD. Clinical and laboratory experience with nimesulide, an NSAID with preferential cyclooxygenase-2 inhibition, suggests that it may be a good candidate for AD therapy.
Methods: This pilot study investigated the clinical feasibility of nimesulide treatment in AD. Forty persons with probable AD, most of whom were taking cholinesterase inhibitors, were enrolled in a randomized, controlled, parallel-group trial designed to assess tolerability and short-term cognitive/behavioral effects of nimesulide. In the initial 12-week double-blind phase, participants were treated with nimesulide 100 mg by mouth twice daily or matching placebo; during the second 12-week phase all participants received active drug. Participants who tolerated the drug well and perceived benefit were invited to continue open-label nimesulide treatment.
Results: Short-term therapy with nimesulide, compared with placebo, had no significant effect on total assessment scores of measures of cognition, clinical status, activities of daily living, affect, and behavior. Long-term therapy was well tolerated for periods exceeding 2 years.
Conclusion: These findings support the feasibility of nimesulide therapy in AD; assessment of efficacy will require a larger, long-term treatment study.
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