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From Johns Hopkins Bayview and Johns Hopkins School of Medicine(G.G.L.), Baltimore; VA Puget Sound Health Care System and University of Washington (J.C.S.B.), Seattle; Boston University School of Medicine (R.C.G.), MA; Johns Hopkins Bloomberg School of Public Health (C.M.), Baltimore; Johns Hopkins School of Medicine (S.P.), Baltimore, MD; and Sun Health Research Institute (M.S.), Sun City, AZ.
Address correspondence and reprint requests to C.G. Lyketsos, Department of Psychiatry, Johns Hopkins Bayview, 5300 Alpha Commons Drive, 4th Floor, Baltimore, MD 21224 kostas{at}jhmi.edu
Objective: To evaluate the efficacy and safety of naproxen and celecoxib for the primary prevention of Alzheimer disease (AD).
Methods: Randomized, placebo-controlled, double-masked clinical trial conducted at six US dementia research clinics. Volunteers aged 70+ years, with cognitive screening scores above designated cut-offs and a family history of AD, were randomly assigned to celecoxib 200 mg BID, naproxen sodium 220 mg BID, or placebo. Enrollment began in early 2001. The main outcome measure was diagnosis of AD after randomization.
Results: On December 17, 2004, treatments were suspended. Events while on treatment yielded hazard ratios vs placebo of 1.99 (95% CI 0.80 to 4.97; p = 0.14) for celecoxib and 2.35 (0.95 to 5.77; p = 0.06) for naproxen. Imperfect screening measures led to enrollment of 7 individuals with dementia and 46 others with milder cognitive syndromes. Their (prevalent) illness was detected at enrollment and diagnosed within 6 months following randomization. Secondary analyses that excluded the 7 cases of prevalent dementia showed increased hazard ratios for AD with both treatments. Neither treatment produced a notable effect on the incidence of milder cognitive syndromes.
Conclusions: These results do not support the hypothesis that celecoxib or naproxen prevent Alzheimer dementia, at least within the early years after initiation of treatment. Masked long-term follow-up of these participants will be essential.
Received September 18, 2006. Accepted in final form January 21, 2007.
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