Developmental Biology - Alzheimer's|
Alzheimer's Phase 3 Clinical Trial
Treating mild Alzheimer's disease using deep brain stimulation...
An estimated 5.5 million people in the United States live with Alzheimer's disease —/ the most common form of dementia.
Keck Medicine of the University of Southern California (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. Based on the results of earlier phases of this clinical trial, the treatment offers a potential benefit for patients with mild Alzheimer's."
Darrin Lee MD PhD, Neurosurgeon, Keck Medicine, USC and principal investigator of the study.
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. 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."
Darrin Lee MD PhD.
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 this trial, patients must be 65 or older, have been diagnosed with mild Alzheimer's, 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.
• Those interested in enrolling in the clinical trial with Keck Medicine can contact Amanda Romano at firstname.lastname@example.org or 213-393-5640. This trial is sponsored by Functional Neuromodulation, Inc.
This trial is sponsored by Functional Neuromodulation, Inc. Deep brain stimulation has been approved by the U.S. Food and Drug Administration since 1997 and has proven to be safe. You can learn more about this particular clinical trial here. For more information about Keck Medicine of USC, please visit news.KeckMedicine.org.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03622905
Recruitment Status: Recruiting
First Posted: August 9, 2018
Last Update Posted: October 19, 2020
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622905
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Keck Medicine of USC is enrolling individuals in a clinical trial to examine the safety and effectiveness of deep brain stimulation to treat mild Alzheimer's disease. CREDIT Functional Neuromodulation, Inc.