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Phase 2 results indicate deep brain stimulation safe for Alzheimer's disease

Phase 2 study results indicated no neurological deficits following deep brain stimulation among individuals with Alzheimer’s disease.

“There are more than five million Americans living with Alzheimer's, and yet there are few promising pharmacologic treatment options for this progressive disease,” study researcher Francisco A. Ponce, MD, of Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, said in a press release. “Previous pilot studies researching the use of [deep brain stimulation] in Alzheimer's have indicated the potential to slow cognitive decline in some patients, and have even shown metabolic changes in the brain that may slow the progression of the disease.”

To assess safety, efficacy and tolerability of deep brain stimulation in the fornix of individuals with Alzheimer’s disease, researchers conducted the Advance Trial, a multicenter, 12-month, double-blind, randomized, controlled feasibility study. Between June 2012 and April 2014, 42 individuals with mild, probable Alzheimer’s disease received bilateral fornix deep brain stimulation. Study participants had a mean age of 68.2 years.

The mean length of hospitalization was 1.4 ± 0.8 days.

Overall, 61.9% of participants experienced 64 adverse events associated with study procedure. Of these, seven were serious adverse events experienced by five participants (11.9%).

Four participants were required to return to surgery.

Participants did not experience neurological deficits as a result of deep brain stimulation.

“The first phase of this study was designed to evaluate the 90-day postoperative safety of this particular surgical method. While the study was relatively small, we believe the data suggest that [deep brain stimulation] surgery targeting the fornix can be performed safely in this patient population. The hope is that our positive surgical experience will help pave the way for future research into [deep brain stimulation] and Alzheimer’s,” Ponce said in the release. – by Amanda Oldt

Disclosure: Please see the full study for a list of all authors’ relevant financial disclosures.