-- HealthDay staff
THURSDAY, March 14 (HealthDay News) -- In an effort to quickly
develop drugs that could prevent or slow Alzheimer's, the U.S. Food
and Drug Administration said it plans to relax the approval process
for experimental medications for the memory-robbing disease.
In a proposal published online in the March 14 issue of the
New England Journal of Medicine, the FDA said clinical
trials of people in the early stages of Alzheimer's would only need
to show improvement in tests of thinking and memory. Among these
patients, who are only starting to show subtle mental declines,
improvements in daily functioning would not have to be seen,
The New York Timesreported.
The FDA's goal is to speed development of drugs to treat a
disease that has no cure, so that the millions of aging baby
boomers at risk for Alzheimer's might be able to prevent or slow
the degenerative disease. The FDA is taking comments on the
proposal, and will possibly make revisions, but the plan is going
forward, agency officials said.
Drug companies would still be required to do post-marketing
studies on any approved drugs, to confirm their benefits and
safeguard against any potential harms from long-term use of these
More than 5 million Americans are living with Alzheimer's,
according to the Alzheimer's Association, which translates into one
in eight seniors.
And those numbers are expected to swell in the next 20 years,
according to the U.S. National Institute on Aging (NIA). The
65-and-older population is expected to double to about 72 million
in two decades, and the number of people with Alzheimer's doubles
for every five-year interval past age 65, studies have shown. The
number of the very elderly, age 85 and older, is estimated to
triple by 2050, the NIA added.
For more on Alzheimer's disease, go to the
U.S. National Library of Medicine.
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