Alzheimer's Disease Anti-Inflammatory Prevention Trial: Design, methods, and baseline results

Abstract

Background The Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) was designed to address whether non-steroidal anti-inflammatory drugs (NSAIDs) can prevent or delay the onset of Alzheimer's disease (AD). Methods ADAPT was a randomized, double-placebo-controlled, multicenter chemoprevention trial conducted at six U.S. dementia research clinics. At entry, participants were required to test “normal” on a battery of cognitive tests and to be age 70+ with a family history of Alzheimer-like dementia. Persons were randomly assigned to 200 mg b.i.d. celecoxib (Celebrex, Pfizer), 220 mg b.i.d. naproxen sodium (Aleve, Bayer), or placebo. The primary outcome measure was AD. Secondary outcome measures were cognitive decline and measures related to safety of the treatments when used long term. ADAPT was designed to detect a 30% reduction in AD incidence with 80% power. The estimated sample size requirement was 2,625. Results Enrollment began in March 2001 and ended in December 2004 when treatments were suspended because of concerns regarding cardiovascular safety of the treatments. Followup ranged from 1 to 46 months. The achieved enrollment was 2,528. Recruitment was achieved primarily via mailings to people aged 70+ living in the catchment areas of the six field sites.