Promising Alzheimer’s disease treatment using brain stimulation heads to phase 3 clinical trial

LOS ANGELES, Calif. — Doctors in California are giving millions of people dealing with Alzheimer’s disease hope a treatment may finally be on the way. Researchers at the University of Southern California say a phase 3 clinical trial will work to see if electrical stimulation can fight off mild cases of the illness.

Keck Medicine of USC says they are part of the trial taking place in 20 international locations which will implant electrodes into the patients’ brains. Researchers will be testing how electrical impulses affect the fornix. This region of the brain has a connection to both 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 neurosurgeon Darrin Lee in a university release. “Based on the results of earlier phases of this clinical trial, the treatment offers a potential benefit for patients with mild Alzheimer’s.”

Alzheimer’s is the most common form of dementia. Researchers estimate over five million people in the United States are living with the disease. Alzheimer’s is a degenerative condition in which neural connections between brain cells stop working and the cells themselves die off. Eventually, this leads to memory loss, severe cognitive decline, and death.

Treatment could ‘reawaken brain activity’ in people with mild Alzheimer’s

Around 200 patients in Canada, Germany, and the U.S. will undergo this procedure and be tested for four years. Each participant will be over 65 and have been diagnosed with a mild case of Alzheimer’s.

Participants will have electrodes implanted into their brains that connect to a battery pack underneath the collarbone. (Credit: Functional Neuromodulation, Inc.)

The randomized, double-blind study will first give the seniors a standard assessment for dementia patients. This will give researchers a baseline for each person’s cognitive ability before treatment. After that, the implants will be inserted and connected to a battery pack under the collarbone much like a pacemaker for the heart.

During the first year, patients will either receive low-frequency, high-frequency, or no stimulation to the brain. They will also be taking more cognitive tests to check if their conditions are improving.

“For those with Alzheimer’s disease, certain parts of the brain become atrophied,” Lee explains. “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.”

Once researchers measure these results, they’ll determine what the best amount of electrical stimulation is. For the remaining three years, all of the participants will receive that ideal level of treatment. The team will continue to measure how their cognitive abilities react and, hopefully, resist the devastating effects of dementia.

The trial is being sponsored by Functional Neuromodulation, Inc.

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