Functional Neuromodulation said yesterday that it has begun a pivotal clinical trial to assess deep brain stimulation (DBS) in patients with mild Alzheimer’s disease.
The Minneapolis-based company said the study will evaluate the safety and efficacy of stimulating the fornix (DBS-f) — a major inflow and output pathway in the brain’s memory circuit. Research suggests that this is an area affected early in the development of Alzheimer’s, the company said.
The ADvance II study is a randomized, double-blind, controlled trial involving up to 210 people 65 years or older with mild Alzheimer’s disease. It is being conducted in the United States, Canada and Germany. The first patient was enrolled at Barrow Neurological Institute in Phoenix, Ariz.
The trial’s investigators are using the Boston Scientific (NYSE:BSX) Vercise directional system, which is designed to precisely stimulate the pathway in the brain’s memory circuit, according to Functional Neuromodulation.
“There is an urgent need for new ways to treat Alzheimer’s. 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,” said company CEO Todd Langevin in a news release. “Based on encouraging results from the feasibility trial, we have worked closely with a stellar group of scientific, clinical and regulatory experts to design ADvance II to determine if DBS-f could be a new circuitry-based approach to treating this devastating disease.”
The ADvance II study is based on the results of the previous ADvance study, begun in 2013, which suggested beneficial effects of DBS-f in patients 65 years or older.
“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 Alzheimer’s,” added Dr. Anna Burke, director of the Alzheimer’s and memory disorders division at Barrow Neurological Institute. “The ADvance II study will enable us to assess whether stimulating the brain with DBS-f can drive neural activity in a way that might lead to better clinical outcomes.”