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June 3, 2003 — Use of the nonsteroidal anti-inflammatory drugs (NSAIDs) rofecoxib or naproxen does not slow the cognitive decline of patients with mild-to-moderate Alzheimer's Disease (AD), according to a study in the June 4 issue of The Journal of the American Medical Association (JAMA).
Laboratory evidence that inflammatory mechanisms contribute to neural injury in AD, along with evidence from epidemiological studies, suggest that NSAIDs may favorably influence the clinical course of the disease, according to background information in the article. Alzheimer's disease is among the most important health problems of elderly persons, affecting more than four million people in the United States.
Paul S. Aisen, M.D., of the Department of Neurology, Georgetown University Medical Center, Washington, D.C., and colleagues tested the hypothesis that NSAID treatment would slow the rate of cognitive decline in individuals with mild to moderate AD. The study was a multicenter, randomized, double-blind, placebo-controlled trial with one-year exposure to study medications, conducted at 40 ambulatory treatment centers affiliated with the Alzheimer's Disease Cooperative Study consortium. The study included 351 participants, recruited from December 1999 to November 2000, with mild to moderate AD.
Participants were randomized to take rofecoxib (n=122) once-daily, 25 mg, or twice-daily naproxen sodium (n=118), 220 mg, or placebo (n=111). The researchers found that the one year average change in Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-Cog, an instrument that evaluates memory, attention, reasoning, language, orientation and established practice, with a range of scores from zero to seventy) scores in participants treated with naproxen (5.8) or rofecoxib (7.6 ) was not significantly different from the change in participants treated with placebo (5.7 ). Results of secondary analyses showed no consistent benefit with either treatment.
Fatigue, dizziness and hypertension were more commonly reported in the active drug groups, and more serious adverse events were found in the active treatment group than in the placebo group, although that difference was not significant.
"The results of the current study do not support the hypothesis that rofecoxib or naproxen can slow the progression of AD. Considering the risk of serious toxicity, such treatment should not be recommended," the authors write.
In an accompanying editorial, Lenore J. Launer, Ph.D., of the National Institute on Aging, Bethesda, Md., writes that AD is a devastating disease and drugs that might slow disease progression before and after the clinical threshold has been reached are urgently needed.
"In addition to critically evaluating the existing literature, new studies with focused questions about a particular drug will be needed. A wide range of pathology underlies the dementia of older persons. While the (Aisen et al) study clearly indicates that these NSAIDs are not effective in slowing cognitive decline as measured by the change in ADAS-Cog score in this group of patients, these agents may still be effective in another population. An at-risk population with a family history of AD is currently under study as a part of the ADAPT (Alzheimer's Disease Anti-inflammatory Prevention Trial). Additional rigorous trials and observational studies of NSAIDs will also help determine whether NSAIDs might be candidate drugs for other populations at risk for AD," she concludes.