FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Deep Brain Stimulation Trial Shows Benefit in Patients With Mild Alzheimer’s

Nov. 9, 2015

Functional Neuromodulation’s Phase 2 trial using deep brain stimulation of the fornix for mild Alzheimer's disease suggested clinical benefit at 12 months in patients aged 65 and older.

DBS uses a surgically implanted device to deliver mild electrical pulses to precisely targeted areas of the brain.

Glucose metabolism, a biomarker for neuronal degeneration and disease progression, increased by 22 percent on average at 12 months in patients treated with DBSf,  while the placebo group declined by 1.2 percent on average. 

The surgery and brain stimulation also demonstrated acceptable safety, according to the Boston, Mass.-based company. — Michael Cipriano