Long-term efficacy and safety of celecoxib in Alzheimer's disease.
OBJECTIVE
Cyclooxygenase-2 (COX-2) may play an important role in the neuropathology of Alzheimer's disease (AD). The efficacy and safety of celecoxib (200 mg bid), a COX-2 selective inhibitor, were assessed in patients > or =50 years with established mild-to-moderate AD to determine whether treatment was effective in retarding deterioration of cognitive function.


METHODS
This was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The primary efficacy end points were the change from baseline to week 52 in the Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-cog) composite score and the week 52 Clinician's Interview-Based Impression of Change Plus (CIBIC+).


RESULTS
At 52 weeks, change in ADAS-cog scores from baseline was similar for placebo and celecoxib 200 mg bid groups (5.00 and 4.39, respectively). CIBIC+ scores were also similar (4.83 and 4.92). Two extension studies were conducted but were terminated early based on these efficacy results. Safety data from all 3 studies indicated that celecoxib was generally well-tolerated.


CONCLUSIONS
Celecoxib 200 mg bid did not slow the progression of AD in this study, and the occurrence of adverse events was as expected for an elderly population with a complex chronic medical condition.
Soininen
Hilkka
H
Department of Neurology, Kuopio University Hospital and Department of Neurology, Brain Research Unit, Clinical Research Center, Mediteknia, University of Kuopio, Kuopio, Finland. hilkka.soininen@uku.fi
West
Christine
C
Robbins
Jeffery
J
Niculescu
Liviu
L
D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000068579:Celecoxib; D003072:Cognition Disorders / Q000175:diagnosis / Q000453:epidemiology; D003710:Demography; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000453:epidemiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib