A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

Phase 2/3 Completed National Institute on Aging (NIA) Alzheimer's Disease Cooperative Study (ADCS) · collab

RandomizedDouble-blindTreatment

Summary

The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.

Timeline

Start: —
Primary completion: 2001-12
Completion: 2001-12

Outcome

Missed primary endpoint

paper change in ADAS-Cog scores in participants treated with naproxen (5.8 [8.0]) or rofecoxib (7.6 [7.7]) was not significantly different PMID 12783912 ↗

Publications

Results Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ; Alzheimer's Disease Cooperative Study. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003 Jun 4;289(21):2819-26. doi: 10.1001/jama.289.21.2819.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naproxen	Small molecule	220 mg	—
Subject	rofecoxib	Small molecule	25 mg	—