Phase 3 clinical trial to treat mild Alzheimer's disease using deep
brain stimulation
While FDA-approved technique is used to treat other medical conditions,
this study examines its effects on cognitive function

Date:
October 21, 2020
Source:
University of Southern California - Health Sciences
Summary:
Medical researchers are enrolling individuals in an international
phase 3 clinical trial to examine the safety and effectiveness
of deep brain stimulation to treat Alzheimer's. The study uses
electrical impulses to stimulate the region of the brain known as
the fornix, which is associated with memory and learning.



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An estimated 5.5 million people in the United States live with Alzheimer's disease, which is the most common form of dementia.


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Keck Medicine of USC is enrolling individuals in an international phase
3 clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer's. The study uses electrical impulses to stimulate the region of the brain known as the fornix, which is associated
with memory and learning.

"Deep brain stimulation has successfully treated conditions such
as Parkinson's disease by improving motor skills, and we are now
investigating if this therapy can stabilize or improve cognitive
function," says Darrin Lee, MD, PhD, a neurosurgeon with Keck Medicine
of USC and the site's principal investigator of the study. "Based on the results of earlier phases of this clinical trial, the treatment offers a potential benefit for patients with mild Alzheimer's." This randomized, double-blind study will last four years. Subjects will first take a standardized assessment test for Alzheimer's to be used as a baseline
measure of cognitive ability throughout the study.

Next, researchers will implant electrodes into subjects' brains that
connect to a battery pack, similar to a heart pacemaker, placed underneath
the collarbone.

For the first year of the study, subjects will be given either
low-frequency stimulation to the brain, high-frequency stimulation or
a placebo -- no stimulation.

"For those with Alzheimer's disease, certain parts of the brain become atrophied," Lee says. "We are testing to see if stimulating the brain's
fornix can reawaken brain activity in this area and stop the progression
of the disease." During the first year, subjects will be given subsequent cognitive tests to check if their memory or learning skills have held
steady or improved. At the end of the year, study researchers will
examine data to determine which level of stimulation had the most impact
on these skills.

For the next three years of the trial, all subjects in the study will
receive what researchers have determined is the optimal frequency of deep
brain stimulation, even those originally receiving the placebo. Patients
will continue to be given cognitive assessments throughout the four-year period.

To qualify for the trial, patients must be 65 or older, have been
diagnosed with mild Alzheimer's and take Alzheimer's medication, and
have a caregiver or family member who can accompany them to doctor visits.

The clinical trial involves approximately 200 patients at some 20 sites
in the United States, Canada and Germany. Keck Medicine plans to enroll
8-15 patients.

The trial is sponsored by Functional Neuromodulation, Inc.


========================================================================== Story Source: Materials provided by University_of_Southern_California_-_Health_Sciences.

Note: Content may be edited for style and length.


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Link to news story: https://www.sciencedaily.com/releases/2020/10/201021085100.htm

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