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."