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- Title
Effects of Rofecoxib or Naproxen vs Placebo on Alzheimer Disease Progression: A Randomized Controlled Trial.
- Authors
Aisen, Paul S.; Schafer, Kimberly A.; Grundman, Michael; Pfeiffer, Eric; Sano, Mary; Davis, Kenneth L.; Farlow, Martin R.; Jin, Shelia; Thomas, Ronald G.; Thal, Leon J.
- Abstract
Context: Laboratory evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer disease (AD), along with epidemiological evidence, suggests that nonsteroidal anti-inflammatory drugs (NSAIDs) may favorably influence the course of the disease. Objective: To determine whether treatment with a selective cyclooxygenase (COX) -2 inhibitor (rofecoxib) or a traditional nonselective NSAID (naproxen) slows cognitive decline in patients with mild-to-moderate AD. Design: Multicenter, randomized, double-blind, placebo-controlled, parallel group trial, with 1-year exposure to study medications. Setting: Forty ambulatory treatment centers affiliated with the Alzheimer's Disease Cooperative Study consortium. Participants: Participants with mild-to-moderate AD (Mini-Mental State Examination score of 13-26) were recruited from December 1999 to November 2000 using clinic populations, referrals from community physicians, and local advertising. Stable use of cholinesterase inhibitors, estrogen, low-dose aspirin, and vitamin E was allowed. Participants with inflammatory diseases that might respond to the study medications were excluded. Of 474 participants screened, 351 were enrolled. Interventions: Once-daily rofecoxib, 25 mg, or twice-daily naproxen sodium, 220 mg, or placebo. Main Outcome Measures: The primary outcome measure was the 1-year change in the Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) subscale score. Secondary outcome measures included the Clinical Dementia Rating scale sum-of-boxes, the Neuropsychiatric Inventory, the Quality of Life-AD, and the time to attainment of significant end points (4-point decline from baseline ADAS-Cog score, 1-step worsening on the global Clinical Dementia Rating scale, 15-point decline on the ADCS activities of daily living inventory, institutionalization, or death). Results: The 1-year mean (SD) change in ADAS-Cog scores in participants treated with naproxen (5.8 [8.0]) or rofecoxib (7.6 [7.7]) was not...
- Subjects
ALZHEIMER'S disease; DEMENTIA prevention; NAPROXEN; CYCLOOXYGENASE 2 inhibitors; HEALTH outcome assessment
- Publication
JAMA: Journal of the American Medical Association, 2003, Vol 289, Issue 21, p2819
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.289.21.2819