Advance Study

ADvance StudyFunctional Neuromodulation initiated the ADvance Study in the U.S. and Canada to assess the safety and potential clinical benefit of deep brain stimulation of the fornix (DBS-f) in patients with mild Alzheimer’s disease. Enrollment of ADvance was completed in April 2014 with 42 patients having a DBS system implanted. Top-line outcomes data were reported in 2015. See news article

ADvance was a randomized trial of patients aged 45-85 with mild Alzheimer’s disease.  The trial compared the effects of DBS turned on to those observed with the system turned off.  The patients underwent regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group were eligible to have the system activated.  Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory were assessed at multiple time points. 

ADvance was conducted at seven leading research centers in North America: Banner Alzheimer's Institute in Phoenix, Ariz.; Banner Sun Health Research Institute in Sun City, Ariz.; Butler Hospital and Rhode Island Hospital in Providence, R.I.; Johns Hopkins Bayview Medical Center in Baltimore, Md.; Toronto Western Hospital in Toronto, Ont.; University of Florida Center for Movement Disorders and Neurorestoration in Gainesville, Fla; and the University of Pennsylvania in Philadelphia, Pa.

ADvance was co-chaired by Andres Lozano, MD, PhD, R.R. Tasker Chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto and Scientific Founder of the company; and Constantine Lyketsos, MD, MHS, Elizabeth Plank Althouse Professor, Johns Hopkins University, and Director, Johns Hopkins Memory and Alzheimer's Treatment Center.

CAUTION — Investigational device. Limited by Federal law to investigational use.

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