This Article  • Full text  • PDF  • CME Course for This Article  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Contact me when this article is cited  Related Content  • Related article  • Similar articles in this journal  Topic Collections  • Drug Therapy, Other  • Alzheimer Disease  • Cognitive Disorders  • Randomized Controlled Trial  • Prognosis/ Outcomes  • Drug Therapy  • Alert me on articles by topic

Results of a Randomized, Controlled Trial of Naproxen and Celecoxib

ADAPT Research Group^*

Arch Neurol. 2008;65(7):896-905. Published online May 12, 2008 (doi:10.1001/archneur.2008.65.7.nct70006).

Background  Observational studies have shown reduced risk of Alzheimer dementia in users of nonsteroidal anti-inflammatory drugs.

Objective  To evaluate the effects of naproxen sodium and celecoxib on cognitive function in older adults.

Design  Randomized, double-masked chemoprevention trial.

Setting  Six US memory clinics.

Participants  Men and women aged 70 years and older with a family history of Alzheimer disease; 2117 of 2528 enrolled had follow-up cognitive assessment.

Interventions  Celecoxib (200 mg twice daily), naproxen sodium (220 mg twice daily), or placebo, randomly allocated in a ratio of 1:1:1.5, respectively.

Main Outcome Measures  Seven tests of cognitive function and a global summary score measured annually.

Results  Longitudinal analyses showed lower global summary scores over time for naproxen compared with placebo (– 0.05 SDs; P = .02) and lower scores on the Modified Mini-Mental State Examination over time for both treatment groups compared with placebo (– 0.33 points for celecoxib [P = .04] and – 0.36 points for naproxen [P = .02]). Restriction of analyses to measures collected from persons without dementia attenuated the treatment group differences. Analyses limited to measures obtained while participants were being issued study drugs produced results similar to the intention-to-treat analyses.

Conclusions  Use of naproxen or celecoxib did not improve cognitive function. There was weak evidence for a detrimental effect of naproxen.

Trial Registration  clinicaltrials.gov identifier: NCT00007189

*Authors/Writing Committee: The following members of the ADAPT Group take authorship responsibility: Barbara K. Martin, PhD (primary author), and Christine Szekely, PhD , Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Jason Brandt, PhD (writing committee chair), and Steven Piantadosi, MD, PhD , Johns Hopkins School of Medicine, Baltimore; John C. S. Breitner, MD, MPH , and Suzanne Craft, PhD , Veterans Affairs Puget Sound Health Care System and University of Washington, Seattle; Denis Evans, MD , Rush University Medical Center, Chicago, Illinois; Robert Green, MD , Boston University School of Medicine, Boston, Massachusetts; and Michael Mullan, MD , The Roskamp Institute Memory Clinic, Tampa, Florida.

RELATED ARTICLE

This Month in Archives of Neurology
Arch Neurol. 2008;65(7):871-872.
FULL TEXT