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Alzheimer's Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results.

ABSTRACT: 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).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.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.

SUBMITTER: ADAPT Research Group

PROVIDER: S-EPMC2866447 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

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Alzheimer's Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results.

Meinert Curtis L CL McCaffrey Lee D LD Breitner John C S JC

Alzheimer's & dementia : the journal of the Alzheimer's Association 20090301 2

<h4>Background</h4>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).<h4>Methods</h4>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 ...[more]

PMID: 19328435

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Project description:ObjectivesThe Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) was designed to evaluate the conventional NSAID naproxen sodium and the selective COX-2 inhibitor celecoxib for primary prevention of Alzheimer's dementia (AD). On 17 December 2004, after the Adenoma Prevention with Celecoxib (APC) trial reported increased cardiovascular risks with celecoxib, the ADAPT Steering Committee suspended treatment and enrollment. This paper reports on cardiovascular and cerebrovascular events in ADAPT.DesignADAPT is a randomized, placebo-controlled, parallel chemoprevention trial with 1-46 mo of follow-up.SettingThe trial was conducted at six field sites in the United States: Baltimore, Maryland; Boston, Massachusetts; Rochester, New York; Seattle, Washington; Sun City, Arizona; and Tampa, Florida.ParticipantsThe 2,528 participants were aged 70 y and older with a family history of AD.InterventionsStudy treatments were celecoxib (200 mg b.i.d.), naproxen sodium (220 mg b.i.d.), and placebo.Outcome measuresOutcome measures were deaths, along with nonfatal myocardial infarction (MI), stroke, congestive heart failure (CHF), transient ischemic attack (TIA), and antihypertensive treatment recorded from structured interviews at scheduled intervals. Cox proportional hazards regression was used to analyze these events individually and in several composites.ResultsCounts (with 3-y incidence) of participants who experienced cardiovascular or cerebrovascular death, MI, stroke, CHF, or TIA in the celecoxib-, naproxen-, and placebo-treated groups were 28/717 (5.54%), 40/713 (8.25%), and 37/1070 (5.68%), respectively. This yielded a hazard ratio (95% confidence interval [CI]) for celecoxib of 1.10 (0.67-1.79) and for naproxen of 1.63 (1.04-2.55). Antihypertensive treatment was initiated in 160/440 (47.43%), 147/427 (45.00%), and 164/644 (34.08%). This yielded hazard ratios (CIs) of 1.56 for celecoxib (1.26-1.94) and 1.40 for naproxen (1.12-1.75).ConclusionsFor celecoxib, ADAPT data do not show the same level of risk as those of the APC trial. The data for naproxen, although not definitive, are suggestive of increased cardiovascular and cerebrovascular risk.

Dataset Information

Alzheimer's Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results.

Publications

Alzheimer's Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results.

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