Toronto-based Functional Neuromodulation won FDA approval to expand the U.S. arm of its Alzheimer’s study from 20 to 30 patients who will receive the company’s deep brain stimulation implant.
The device maker is already halfway through initial enrollment for its ADvance trial, which was slated to enroll 20 U.S. and 20 Canadian patients with mild Alzheimer’s disease, provide them with DBS systems and compare the effects of the systems turned on versus systems turned off.
"The study investigators have been very diligent in enrolling appropriate patients with early Alzheimer’s disease," Functional Neuromodulation president & COO Todd Langevin said in prepared remarks. "We expect our progress to accelerate as we now have active teams of Alzheimer’s and neurosurgical experts in place and recruiting at 7 leading research centers in North America."
Arizona’s Banner Sun Health Research Institute and Providence’s Rhode Island Hospitals recently joined the clinical trial, marking the 6th and 7th research centers participating in the ADvance study.
Researchers are evaluating deep-brain stimulation directed at the fornix, a region of the brain associated with the flow of memory. The device is "similar to a cardiac pacemaker," in that it delivers mild electrical shocks to targeted areas inside the body. The new study is enrolling patients between the ages of 55 and 80 who have mild symptoms of Alzheimer’s disease. They are provided with DBS implants that will likely remain in their bodies for the rest of their lives. Researchers plan to follow the enrolled patients for at least 18 months, conducting regular assessments to determine how their Alzheimer’s disease has progressed.
Functional Neuromodulation has support from DBS pioneer and medtech titan Medtronic (NYSE:MDT), which as provided capital investment and hardware for use during the ADvance study. Medtronic’s DBS systems have U.S. approval for a variety of disorders, including Parkinson’s disease, essential tremor, dystonia and obsessive-compulsive disorder.
"Alzheimer’s is a growing public health concern, and with the recent disappointments in drug research, we urgently need new ideas," ADvance principal investigator Dr. Stephen Salloway said in prepared remarks. "DBS has helped transform the treatment of Parkinson’s disease and we hope that stimulation of memory circuits can have a similar benefit in treating Alzheimer’s disease."