Drugs Fail to Slow Alzheimer Progression


A new clinical trial has found that two nonsteroidal, anti-inflammatory drugs (NSAIDs) do not slow the rate of cognitive decline in patients with mild to moderate Alzheimer's disease (AD). The multicenter study was supported by the National Institute on Aging (NIA) and reported in the June 4, 2003, issue of the Journal of the American Medical Association (JAMA). This is the first clinical trial to prospectively test rofecoxib (Vioxx®), a selective cyclooxygenase-2 (COX-2) inhibitor, and naproxen (Naprosyn®), a nonselective NSAID, in patients with AD.

The researchers, led by principal investigator Paul S. Aisen, M.D., of Georgetown University Medical Center in Washington, D.C, randomly assigned 351 participants to one of three treatment groups: rofecoxib, naproxen, or placebo. The investigators measured cognition before and after treatment by scores on the Alzheimer's Disease Assessment Scale, a test that evaluated memory, attention, reasoning, language, and orientation.

After 12 months of treatment, both the rofecoxib and naproxen groups showed cognitive declines similar to those of the placebo group. Although the results do not eliminate the possibility of a small beneficial effect, it appears unlikely that naproxen or rofecoxib treatment reduces the one-year rate of cognitive decline, even by as much as one third.

Although the study did not show a benefit in patients who already had AD, NSAIDs might still prove to be effective in preventing the disease, says Neil Buckholtz, Ph.D., chief of the NIA's Dementias of Aging Branch. An NIA-supported prevention trial of NSAIDs is ongoing.

In an editorial in the same issue of JAMA, neuroepidemiologist Lenore Launer, Ph.D., of the NIA's Laboratory of Epidemiology, Demography, and Biometry, points out that the study participants met specific criteria and that the outcome might be different, and possibly beneficial, in other patients with AD or in those at risk for the disease.

The trial was conducted at 40 centers nationwide and was organized under the Alzheimer's Disease Cooperative Study (ADCS), a consortium of academic and other research centers supported by the NIA to coordinate and facilitate the clinical testing of compounds to prevent AD or delay the onset of its symptoms.

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