TY - JOUR
T1 - Cognitive function over time in the Alzheimer's disease anti-inflammatory prevention trial (ADAPT)
T2 - Results of a randomized, controlled trial of naproxen and celecoxib
AU - Martin, Barbara K.
AU - Szekely, Christine
AU - Brandt, Jason
AU - Piantadosi, Steven
AU - Breitner, John C.S.
AU - Craft, Suzanne
AU - Evans, Denis
AU - Green, Robert
AU - Mullan, Michael
PY - 2008/7
Y1 - 2008/7
N2 - 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 (200mgtwice 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.
AB - 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 (200mgtwice 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.
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U2 - 10.1001/archneur.2008.65.7.nct70006
DO - 10.1001/archneur.2008.65.7.nct70006
M3 - Article
C2 - 18474729
AN - SCOPUS:47549107705
VL - 65
SP - 896
EP - 905
JO - Archives of Neurology
JF - Archives of Neurology
SN - 0003-9942
IS - 7
ER -