Naproxen and celecoxib do not prevent AD in early results from a randomized controlled trial

Constantine G Lyketsos, John C.S. Breitner, R. C. Green, B. K. Martin, Curtis L Meinert, S. Piantadosi, M. Sabbagh

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1800-1808
Number of pages9
JournalNeurology
Volume68
Issue number21
DOIs
StatePublished - May 2007

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Celecoxib
Naproxen
Alzheimer Disease
Randomized Controlled Trials
Dementia
Placebos
Random Allocation
Therapeutics
Primary Prevention
Volunteers
Outcome Assessment (Health Care)
Clinical Trials
Safety

ASJC Scopus subject areas

  • Neuroscience(all)

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Naproxen and celecoxib do not prevent AD in early results from a randomized controlled trial. / Lyketsos, Constantine G; Breitner, John C.S.; Green, R. C.; Martin, B. K.; Meinert, Curtis L; Piantadosi, S.; Sabbagh, M.

In: Neurology, Vol. 68, No. 21, 05.2007, p. 1800-1808.

Research output: Contribution to journalArticle

Lyketsos, Constantine G ; Breitner, John C.S. ; Green, R. C. ; Martin, B. K. ; Meinert, Curtis L ; Piantadosi, S. ; Sabbagh, M. / Naproxen and celecoxib do not prevent AD in early results from a randomized controlled trial. In: Neurology. 2007 ; Vol. 68, No. 21. pp. 1800-1808.
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AB - 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.

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