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AlzRisk Paper Detail

Reference: ADAPT, 2013
Cohort: Alzheimer's Disease Anti-inflammatory Prevention Trial
Risk Factor: Non-Steroidal Anti-Inflammatory Drugs

Average Follow-up Time Detail
Among the 2528 participants who were enrolled in the ADAPT study between March 2001 to December 2004, 2257 participants were eligible for cognitive assessment in ADAPT-FS. The cognitive assessment occurred approximately three years after the close of ADAPT. The final analytical sample included 1537 participants because 720 participants did not have an ADAPT-FS cognitive assessment due to the following reasons: 172 had died between ADAPT and ADAPT-FS, 41 were too ill to participate, 297 were unavailable or refused, 20 agreed to participate but could not be reached, and 190 could not be located.

Exposure Detail
In the ADAPT study, participants were randomized to either celecoxib 200 mg BID (twice daily), naproxen sodium 220 mg BID, or placebo. The ratio of randomization was 1:1:1.5 (celecoxib: naproxen: placebo). By design, the exposure of each participant was randomly assigned and was analyzed as such (i.e., intention-to-treat analysis; see Covariates & Analysis Detail). The investigators reported results separately for celecoxib use vs. placebo and naproxen use vs. placebo. This entry pertains to results on celecoxib use vs. placebo.

The investigators compared incident AD risk in two groups: the group of participants who were randomly assigned to use celecoxib ("Celecoxib use")and the reference group of participants who were randomly assigned to use placebo ("Placebo").

"While taking the study treatments, 85.6% of participants on celecoxib reported taking drug always or almost always or most of the time, compared with 86.1% on naproxen and 87.9% on placebo. Among participants assigned to celecoxib, 10.7% reported taking proscribed doses of aspirin or NSAID medications at least once, compared with 9.9% of participants on naproxen and 13.3% on placebo."

Age Detail
The median age of participants was 74 years old. At the start of ADAPT-FS, 59% of participants were ages 70-74, 31% of participants were ages 75-79, 9% of participants were ages 80-84, and 1% of participants were at least 85 years old.

Screening and Diagnosis Detail
Screening Method:
Neuropsych Testing
TELETelephone assessment of dementia

AD Diagnosis:
DSM IV Diagnostic and Statistical Manual IV
NINCDS ADRDA National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association Criteria (McKhann 1984)

Covariates & Analysis Detail
Analysis Type:
Cox proportional hazards regression

"Analyses included all randomized ADAPT participants who had at least one cognitive assessment after enrollment. Person-time was censored after the participants’ last completed cognitive assessment; participants who did not complete an ADAPT-FS assessment were censored at their last ADAPT follow-up visit. Time to all-cause death was also compared by treatment group."

"For all analyses, participants were counted in the treatment
group to which they were randomized (intention to treat). By design, naproxen and celecoxib were compared with placebo, and not with one another."

AD Covariates:
CCcity center

TD Covariates:
CCcity center

"Hazard ratios [were] calculated using Cox proportional hazard regression, adjusting for strata (age and clinic)"