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A
new clinical trial finds that two non-steroidal, anti-inflammatory
drugs (NSAIDs) do not slow
the rate of cognitive decline
in people with mild to moderate Alzheimer's disease
(AD). The multicenter study, 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), is
the first clinical trial to prospectively test rofecoxib,
a selective cyclooxygenase-2 (COX-2) inhibitor, and
naproxen, a non-selective NSAID, in people with AD.
The investigators, led by principal investigator Paul
S. Aisen, M.D., of Georgetown University Medical Center,
Washington,
D.C, randomly assigned the study's 351 participants
to one of three treatment groups: rofecoxib, naproxen, or
placebo. Cognition was measured before and after treatment
by scores on the Alzheimer's Disease Assessment
Scale, a test evaluating memory, attention, reasoning,
language,
and orientation.
After 12 months of treatment, both
the rofecoxib and naproxen groups showed cognitive
declines similar to
those found in the placebo group. While the results
do not eliminate the possibility of a very small beneficial
effect,
analysis indicates that it is highly unlikely that
naproxen or rofecoxib treatment reduces the one-year
rate of cognitive
decline, even by as much as one-third.
Although the study failed to show a treatment benefit
in people who already have AD, NSAIDs still could 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 on-going.
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 individuals participating in this study met specific criteria
and the outcome could be different, and possibly beneficial,
in another group of people with AD or in those at risk
for the disease.
The study was conducted at 40 centers nationwide 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. The NIA, part of the
National Institutes of Health (NIH) at the U.S. Department
of Health and Human Services, was the primary funder
of the trial, with additional support provided to Georgetown
University by the National Center for Research Resources,
also part of the NIH.
The rationale for the study was based on previous findings
that inflammation is a central feature of AD. The disease
is an irreversible progressive brain disorder that
occurs gradually and results in memory loss, behavior
and personality changes, and cognitive decline.
The NIA is the lead federal agency conducting
and supporting research on AD and the aging brain.
Its Alzheimer's
Disease Education and Referral (ADEAR) Center
website offers information on age-related memory
change, including
a list of clinical trials testing possible therapies
for AD, at www.alzheimers.org. The public may also
contact ADEAR at 1-800-438-4380.
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