Alzheimer’s guide
February 12, 2013
THE US Food and Drug
Administration has urged
researchers to focus on the early
stages of Alzheimer’s disease, with
a formal proposal on developing
drugs to treat the condition.
“The scientific committee and the
FDA believe that it is critical to
identify and study patients with
very early Alzheimer’s disease
before there is too much
irreversible injury to the brain,” said
Russell Katz, director of the Division
of Neurology Products in the FDA’s
Center for Drug Evaluation and
Research.
A new document released
yesterday explains the FDA’s
current thinking, and the way
researchers can identify and select
suitable patients for participation in
clinical trials.
“This draft guidance is intended
to serve as a focus for continued
discussions between the FDA and
pharmaceutical sponsors, the
academic community, advocacy
groups and the public” Katz said.
He said the FDA is committed to
vigorously addressing the
condition, “and will work with
industry to develop new treatments
i this early population as
expeditiously as possible”.
A key difficulty is that patients
with early-stage Alzheimer’s have
little impairment of global
functioning so it’s very difficult to
assess changes in these people.
The FDA is seeking public
comment on the draft guidance for
60 days, with the proposal part of
US Department of Health efforts
under the government’s National
Plan to Address Alzheimer’s Disease.
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