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The BU ADC is one of six sites nationwide for one of the
largest Alzheimer’s prevention studies ever: the Alzheimer’s
Disease Anti-inflammatory Prevention Trial (ADAPT), funded
by the National Institute on Aging. The study began in April
2001, with over 2,500 participants now enrolled study-wide,
including 424 at the BU site!
“Frequently Asked Questions” about this new phase of ADAPT.
1. How will the role of study participants change?
Although participants will no longer take the study medications, there will be no other changes in study procedures. We will still ask participants to attend regular visits and will check in by phone on a regular basis.
2. How long will the study continue?
The new observational period is scheduled to last at least two more years, during which time we will continue to assess the effectiveness and safety of ADAPT treatments.
3. Can participants resume taking NSAIDs (e.g., Advil, ibuprofen, aspirin) or other medications and supplements that were limited before the study medications were stopped?
There are no longer restrictions on medications or supplements for ADAPT participants. Of course, participants should consult first with their own physicians before beginning or changing any medication(s), and should be careful to take medications only as prescribed.
4. Can participants find out what medication they were taking for ADAPT?
ADAPT will continue to be a “doubleblind” study. That is, in each individual case neither the participant nor the study staff knows what medication was administered. This is important because we are still assessing whether the study medicines taken to date are effective in reducing the risk of AD, and results could be biased if the study became “unblinded.” Participants will be able to learn their ADAPT medication at study’s end.
For more information, contact ADAPT study coordinator Mary-Tara Roth at 617-638-5430. |
ADAPT is based on the theory that certain medications, known
as non-steroidal anti-inflammatory medications (NSAIDs), can
prevent AD. This theory is supported by observational studies
that show fewer cases of AD among people who regularly take
NSAIDs. Specifically, ADAPT is a randomized clinical trial testing
two different types of NSAIDs—naproxen sodium (Aleve)
and celecoxib (Celebrex)—in preventing AD. Celebrex is a
“selective COX-2 inhibitor” and has fewer gastrointestinal side
effects than traditional COX inhibitors such as Aleve. Recently,
however, safety concerns about COX-2-type medications have
been raised. Last December,
a National Cancer Institute sponsored
trial was stopped
because an increased risk
of cardiovascular side effects
was found in people
taking Celebrex compared
with those taking placebo.
Prior to this announcement,
another COX-2 inhibitor
called Vioxx had been
taken off the market for
similar reasons.
Although we did not see similar effects of Celebrex in ADAPT,
we decided to suspend the treatments temporarily while we
gathered more safety information. All BU participants were
informed by telephone and by a mailed letter from site directors
Drs. Robert C. Green and Sanford Auerbach. Since the suspension
of study medicines in December, many agencies, including
the Food and Drug Administration and the National Institutes
of Health, have considered the safety and practical issues of continuing
research with Celebrex and Aleve in prevention trials.
Recently, after a series of discussions, the ADAPT Steering Committee
decided that study medications should be permanently
stopped for all ADAPT participants.
The decision to stop the study medications does not, however,
mean that the study is ending. We will continue to follow all
participants. Continued participation in ADAPT is just as
important as ever! This follow-up period will help answer key
questions of whether short-term treatments with NSAIDs can
prevent AD or slow cognitive decline with aging.
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