Randomized pilot study of nimesulide treatment in Alzheimer's disease.
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.


CONCLUSIONS
These findings support the feasibility of nimesulide therapy in AD; assessment of efficacy will require a larger, long-term treatment study.
Aisen
P S
PS
Department of Neurology, Georgetown University Medical Center, Washington, DC 20007, USA. psa@georgetown.edu
Schmeidler
J
J
Pasinetti
G M
GM
D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008099:Liver / Q000737:chemistry / Q000187:drug effects; D008297:Male; D010865:Pilot Projects; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013449:Sulfonamides; C012655:nimesulide