| Use of Non-Steroidal Anti-Inflammatory Drugs
Suspended in Large Alzheimer's Disease Prevention Trial
The National Institutes of Health (NIH) announced today that research
investigators suspended, until further notice, the use of two drugs,
naproxen (220 mg twice a day) and celecoxib (200 mg twice a day),
in a large, three-arm, national Alzheimer’s disease prevention
trial sponsored by the National Institute on Aging (NIA), a part
of the NIH. The trial, called the Alzheimer’s Disease Anti-Inflammatory
Prevention Trial (or ADAPT) was designed to assess the potential
benefit of long-term use of non-steroidal anti-inflammatory drugs
(NSAIDs) naproxen (Aleve™) and the COX-2 inhibitor
celecoxib (Celebrex™ ) in decreasing the risk of developing
Alzheimer’s Disease in people 70 years of age or older who
were considered to be at increased risk because of family history,
but did not have symptoms of the disease.
Approximately 2400 volunteer participants were randomly assigned
to receive naproxen, celecoxib, or placebo for periods of time up
to three years. Although no significant increase in risk for celecoxib
was found in this trial, the use of these drugs in the study was
suspended in part because of findings reported last week from a
National Cancer Institute (NCI) trial to test the effectiveness
of celecoxib in preventing colon cancer. In addition, however, data
from the ADAPT trial indicated an apparent increase in cardiovascular
and cerebrovascular events among the participants taking naproxen
when compared with those on placebo.
“This step is being taken as a precautionary measure to ensure
the safety of the study’s participants,” said NIH Director,
Elias A. Zerhouni, M.D. “The investigators made their decision
based on the risk/benefit analysis specific to this trial,”
added Dr. Zerhouni.
The ADAPT trial began in 2001 and was conducted at six sites across
the U.S. Tampa, FL; Rochester, NY; Baltimore, MD; Sun City,
AZ; Seattle, WA; and, Boston, MA. The principal investigator for
the study is John Breitner, M.D., of the Veterans Affairs Medical
Center Puget Sound and the University of Washington.
Investigators and NIH scientists will continue to review this and
other NSAIDs studies sponsored by NIH in the light of these findings.
It should be pointed that the cancer prevention trials and the ADAPT
study are among the first long-term, clinical trials to test these
classes of drugs. These studies are examining these compounds for
uses very different from the uses for which these medications are
currently approved. NIH and FDA will work together to provide the
public with information they need to make informed health decisions.
Information for the public and health professionals will be posted
at www.nih.gov as soon as additional
data become available.
The NIH comprises the Office of the Director and 27 Institutes
and Centers. The Office of the Director is the central office at
NIH, and is responsible for setting policy for NIH and for planning,
managing, and coordinating the programs and activities of all the
NIH components. The NIH, the Nation's medical research agency, is
a component of the U.S. Department of Health and Human Services.
The NIA is one of 27 Institutes and Centers at the NIH. It leads
the Federal Government effort conducting and supporting research
on the biomedical and social and behavioral aspects of aging and
the problems of older people. For more information on aging-related
research and the NIA, please visit the NIA website at www.nia.nih.gov.
The public may also call for publications describing these efforts
and offering health information for older people and their families
at 1-800-222-2225, the toll free number for the National Institute
on Aging Information Center.