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MUSC researcher makes major finding
in Alzheimer’s trial
by Tim
Gehret
Public
Relations
An MUSC researcher has made major headway in the battle against
Alzheimer’s disease through a drug trial that significantly reduces the
psychological effects brought on by the disease.
Jacobo Mintzer, M.D., professor in the departments of Neurosciences,
Psychiatry and in the MUSC Center on Aging, announced the landmark
progress this week at the 10th International Conference on Alzheimer’s
Disease and Related Dementias in Madrid, Spain. The announcement
focused on the results of a Phase 2 trial of an investigational drug
for the treatment of Alzheimer’s disease, known as Flurizan. The
presentation described the measure of time to psychiatric events (TPE)
in patients with Alzheimer’s disease and an analysis of the
overall clinical trial of the safety and efficacy of Flurizan.
TPE monitors patients for the occurrence of psychiatric problems such
as agitation, aggression, confusional state and depression. During the
course of the 12-month study conducted at more than 50 sites
nationwide, Mintzer’s study found that approximately 35 percent of
participants taking a placebo experienced cognitive and behavioral
impairment. However, patients with mild Alzheimer’s disease who took
800 mg of Flurizan twice daily had significantly fewer negative events
(14 percent). In addition, the time that elapsed prior to the
occurrence of such an event was significantly longer in patients on
Flurizan than those on a placebo (333 days for Flurizan versus 106 days
for a placebo), suggesting that Alzheimer’s disease patients on
Flurizan more slowly than those on a placebo.
“The decrease in number of psychiatric events and the dramatic
lengthening in time before patients experienced such events while on
Flurizan is an important feature for spouses and caregivers of
Alzheimer’s patients, as well as for the patients themselves,” said
Mintzer. “These events can be as troubling as the more widely
recognized memory loss and decline in cognition to those involved in
the devastating deterioration caused by Alzheimer’s disease.”
An estimated 4.5 million Americans have Alzheimer’s disease, a number
that is expected to grow to 16 million by 2050. Flurizan, developed by
Salt Lake City-based Myriad Genetics Inc., is the first in a new class
of compounds that lowers levels of beta-amyloid, believed to be the
prime factor in buildup of a memory-robbing plaque in the brains of
Alzheimer’s sufferers. Flurizan differs from other Alzheimer’s drugs
already approved by the Food and Drug Administration by preventing
formation of the amyloid plaque (sticky substance on the nerve endings
in the brain) that contributes to the senile characteristic of the
disease.
Based on the positive Phase 2 results, Myriad is enrolling patients
with mild Alzheimer’s disease in a Phase 3 trial at 130 centers across
the United States. The Phase 3 trial is a double blind,
placebo-controlled trial. Patients will be randomized into one of two
arms, receiving either 800 mg of Flurizan or a placebo twice daily for
the duration of the 18-month trial period. The study is designed to
determine Flurizan’s ability to reduce the rate of cognitive decline
and activities of daily living in patients with mild Alzheimer’s
disease, as measured by the ADAS-cog test and the change in ADCS-ADL,
respectively.
More information can be obtained by calling (888) 459-4888.
Friday, July 21, 2006
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