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A clinical trial based on "homegrown" research
from a CWRU laboratory may mean a new direction in treatment for
Alzheimer's disease.
The University Memory and Aging Center,
which is part of CWRU and University Hospitals of Cleveland, is
seeking participants for a medication study based on Alzheimer
Research Laboratory research by Gary Landreth, CWRU professor
of neurosciences and his colleagues.
The trial will test whether people with
Alzheimer's disease can tolerate a medicine called pioglitazone
(PGZ) and whether it might be useful for slowing progression of
the disease. PGZ is already approved by the Food and Drug Administration
(FDA) for treatment of diabetes and is sold under the trade name
Actos.
"We may have a brand-new therapeutic agent
for this disease," Landreth said.
The four drugs already approved by the
FDA for the treatment of Alzheimer's disease work by adding a
chemical that is lacking in the brains of people with Alzheimer's
disease.
"This study involves a different mechanism,"
he said.
UMAC usually tests experimental medications
discovered by the pharmaceutical industry or one of the affiliated
30 Alzheimer Disease Centers in the United States.
With this discovery, David Geldmacher,
UMAC's clinical director, is delighted to report, "We have our
first case where 'homegrown' research discovered in our own labs
will be tested in one of our clinical trials," said David Geldmacher,
UMAC's clinical director and the principal investigator of the
medication trial. Results of the PGZ lab study suggest that drugs
tested so far may not be targeting the right part of an inflammatory
response that occurs in the brains of people with Alzheimer's
disease.
Results of the study were published in
the Journal of Neurosciences.
Under the microscope, Alzheimer's disease
is characterized by abnormal deposits of a protein, called amyloid.
These deposits, or plaques, provoke the brain's immune cells,
called microglia, to try to remove the clumped amyloid. As they
do, the microglia secrete inflammatory chemicals that are toxic
to the brain cells. In the test tube, pioglitazone appears to
reduce the secretion of toxins from microglia when they are exposed
to Alzheimer amyloid.
Thirty people with mild or moderate Alzheimer's
disease will be enrolled for the 18-month study. They must be
older than 50, must not have diabetes currently requiring medical
treatment and must be in generally good health. They also must
have a family member willing to be a study partner and attend
all research visits.
Participants will be able to continue with
standard Alzheimer medicines, will be able to continue taking
vitamin E (200 IU daily) and will have a 50/50 chance of taking
PGZ or a placebo (sugar pill). Participants will receive free
study medications and physical and neurological examinations.
Participation is voluntary, confidential and free of charge.
For information on this study, please contact
Lani Holland at 844-6419 or 1-800-252-5048. To join UMAC's Research
Registry, which may link participants to additional studies, please
contact Kathy Shaw at (216) 844-6326.
UMAC is partially supported by the National
Institute on Aging and is the only center of its kind in Ohio.
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