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Results of a follow-up study to the randomized Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT)


Breitner, J, Baker, L, Drye, L, Alzheimer's Disease Anti-inflammatory Prevention Trial Research Group,


Alzheimer's & Dementia: The Journal Of The Alzheimer's Association, Volume: 9, No.: 6, Pages.: 714-723

Year of Publication



Objectives: The Alzheimer’s Disease Anti-inflammatory Prevention Trial Follow-up Study (ADAPT-FS) was designed to evaluate the efficacy of naproxen and celecoxib for the primary prevention of Alzheimer’s disease (AD) several years after cessation of treatment in ADAPT.; Methods: ADAPT was a randomized, double-masked, multicenter clinical trial of naproxen or celecoxib vs placebo (1:1:1.5 assignment ratio) at six U.S.-based clinics. The trial enrolled 2528 people between 2001 and 2004. Treatments were discontinued in December 2004 and participants were monitored regularly until 2007. In 2010 and 2011, ADAPT-FS screened 1537 participants by telephone and, if indicated, examined them in person using standardized clinical assessments. The primary outcome was time to diagnosis of AD. Death index searches were performed for participants not located.; Results: Eighty-nine additional AD events were identified (24 celecoxib, 25 naproxen, and 40 placebo) yielding a total of 161 events (48 [6.6% of randomized participants] celecoxib, 43 [6.0%] naproxen, and 70 [6.5%] placebo) across ADAPT and ADAPT-FS. Adjusted hazard ratios (HRs) comparing each treatment with placebo showed no overall reduction in risk of AD: HR celecoxib vs placebo, 1.03 (95% confidence interval [CI], 0.72-1.50; P = .86); HR naproxen vs placebo, 0.92 (95% CI, 0.62-1.35; P = .66). There were 349 deaths (110 [15.2%] celecoxib, 96 [13.4%] naproxen, and 143 [13.2%] placebo). Risk of death was similar for the naproxen- and placebo-assigned groups (HR, 0.99; 95% CI, 0.76-1.28; P = .93) and slightly higher for celecoxib compared with the placebo-assigned group (HR, 1.15; 95% CI, 0.90-1.48; P = .27).; Conclusions: These results acquired during a follow-up of approximately 7 years (which included a median of less than 1.5 years of treatment) do not support the hypothesis that celecoxib or naproxen prevent AD in adults with a family history of dementia.; Copyright © 2013 The Alzheimer’s Association. Published by Elsevier Inc. All rights reserved.

Bibtex Citation

@article{2013, doi = {10.1016/j.jalz.2012.11.012}, url = {}, year = 2013, month = {nov}, publisher = {Elsevier {BV}}, volume = {9}, number = {6}, pages = {714--723}, title = {Results of a follow-up study to the randomized Alzheimer{textquotesingle}s Disease Anti-inflammatory Prevention Trial ({ADAPT})}, journal = {Alzheimer{textquotesingle}s {&} Dementia} }


adults, age factors, aged, aged, 80 and over, alzheimer disease, alzheimer’s disease, celecoxib, clinical trial, cognition disorders, complications, dementia, double-blind method, drug therapy, etiology, family, female, history, humans, inflammation, longitudinal studies, male, naproxen, nonsteroidal antiinflammatory drug, of, physical examination, prevention, prevention & control, pyrazoles, sulfonamides, therapeutic use, treatment outcome, with

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Cohort Study

Type of Outcomes



Hospital Outpatient Care

Type of Interventions

Risk Factor Modification

Risk Factor Modifications

At risk population