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# Brain Therapy for Alzheimer’s Breakthrough Status
- URL: https://www.fdaweb.com/brain-therapy-for-alzheimers-breakthrough-status/
- Published: 2021-01-07T12:00:00.000Z
- Updated: 2026-09-14T16:41:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148401

FDA has granted Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation (DBS) System, developed and manufactured by Boston Scientific, for treating patients 65 years and older with mild probable Alzheimer’s disease. Functional Neuromodulation says a pivotal trial is underway to evaluate the safety and efficacy of DBS of the fornix (DBS-f) for patients with mild Alzheimer’s disease, and it will enroll up to 210 patients in the U.S., Canada and Germany. “For Alzheimer’s, 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,” it says. “Under the designation, the Vercise DBS Systems are indicated for unilateral or bilateral stimulation of the post-commissural fornix in the treatment of patients 65 years and older with mild probable Alzheimer’s disease as an adjunctive therapy for patients who are not adequately controlled with medications.”