FDA Grants Breakthrough Device Designation for Deep Brain Stimulation in Alzheimer Disease

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) granted breakthrough device designation for a deep brain stimulation (DBS) system (Vercise; Boston Scientific, Marlborough, MA) being studied for potential treatment of mild Alzheimer disease (AD). This system provides neurostimulation of the fornix, or nerve fibers exiting the hippocampus, known to be among the first structures to degenerate in AD and to play a role in memory formation and recall. The breakthrough device designation is designed to help provide individuals and health care providers have access to medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The ADvance 2 pivotal study (NCT03622905) is currently enrolling up to 210 participants in a randomized, double-blind, controlled clinical trial. The study was designed to evaluate the safety and efficacy of DBS of the fornix (DBS-f) for participants with mild AD. The breakthrough device designation for the DBS system is for potential use as unilateral or bilateral stimulation of the postcommissural fornix to treat individuals age 65 years or more with mild probable AD as an adjunctive therapy.

"There is an urgent need for new ways to treat AD. Pharmacological therapies have shown very limited benefit, and some have considerable side effects. DBS is a promising alternative with a safe and successful track record in other neurological disorders. For AD, DBS-f delivers stimulation to a critical location in the brain's memory circuit that seems to enhance activity in the circuit and drive neuronal activity in other brain regions impacted by the disease. We are encouraged to receive breakthrough device designation," said Todd Langevin, chief executive officer of Functional Neuromodulation, the sponsor of the clinical trial.