Emory
University Tests Safety and Effectiveness of Device for the Possible
Treatment of Alzheimer's Disease
Neurologists
at Emory University are studying a possible new treatment for Alzheimer's
disease using a device called the COGNIShunt, designed to drain cerebrospinal
fluid (CSF) from the skull and into the abdominal cavity. By reducing
the build-up of CSF around the brain, doctors hope this device will
help to stabilize the disease.
CSF is the fluid that fills
the empty spaces around the brain and spinal cord. The body naturally
produces, absorbs, drains and replenishes the fluid. But with age, the
replenishing process slows. "Past research shows that toxic and inflammatory
substances are found in the cerebrospinal fluid of Alzheimer's patients,
which in turn, may lead to brain cell damage," says Allan Levey, M.D.,
Ph.D., professor of neurology, Emory University School of Medicine and
principal investigator of the Emory study. "We hope the COGNIShunt will
help to drain off some of those toxins and allow the CSF to better replenish
itself."
Shunting has long been used
as treatment for hydrocephalus, a condition in which an abnormal accumulation
of CSF causes neurological problems, including dementia, problems walking
and incontinence.
In the Emory study, surgeons
will surgically implant the COGNIShunt into a normal cavity, or ventricle,
in the brain. Then they will tunnel a tube through the neck and into
the abdominal cavity for proper drainage. It is a relatively short and
common procedure that usually requires a one-to two-day hospital stay.
The duration of the study,
at Emory and 11 other sites, is 18 months. The first nine months of
the study is double-blind placebo, meaning all participants will receive
the shunt but the shunt will not be open, or working, in the placebo
group. The second nine months of the trial is open-label, meaning participants
in the placebo group can have their shunt revised to be opened, so it
will work. Eunoe, Inc., the maker of the COGNIShunt, is funding this
clinical trial to assess the effectiveness of the treatment and to test
the hypothesis that the toxic and inflammatory factors in CSF contribute
to the pathology of Alzheimer's disease.
An Alzheimer's researcher
for 15 years, Dr. Levey points out, "Treatment methods vary greatly
in other diseases, but with Alzheimer's, this is the first time more
diverse, therapeutic options are being tested. We hope this surgical
option will lead to dramatic benefits for these patients, and in the
long run, open up even more avenues for surgical treatments. Surgical
treatment options sometimes produce dramatic benefits and are rapidly
gaining acceptance for related neurodegenerative disorders such as Parkinson's
disease."
In a pilot study of the COGNIShunt,
the device was well tolerated by individuals with mild to moderate Alzheimer's
disease. As with most surgical procedures, there are some risks associated
with implanting the device. The risks include infections, bleeding or
a chance that the shunt or tube could stop working. But doctors hope
to prove the benefits of this device will outweigh the risks.
Three other Emory doctors
will serve as co-principal investigators of the study. They are Jim
Lah, M.D., Ph.D., assistant professor of neurology, Nelson Oyesiku,
M.D., associate professor of neurosurgery, and Larry Tune, M.D. professor
of psychiatry and behavioral sciences.
Participants are being recruited
for this study. Criteria include mild to moderate Alzheimer's disease
with no other causes of dementia. Participants can remain on their prescribed
medications throughout the trial. Participants must be between the ages
of 62 and 85 and be in good, general health. To find out more about
this study, call (404) 728-6453.
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