Functional Neuromodulation has 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.
ADvance is a randomized double-blind controlled feasibility study initially involving 20 people aged 55-80 with mild Alzheimer’s disease. The trial will compare the effects of DBS turned on to those observed with the system turned off. The patients will undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group will be eligible to have the system activated. Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory will also be assessed at multiple time points.
ADvance is 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.
ADvance is currently recruiting patients at the Banner Alzheimer's Institute in Phoenix, AZ, Johns Hopkins Bayview Medical Center, Toronto Western Hospital, University of Florida Center for Movement Disorders and Neurorestoration and the University of Pennsylvania.
CAUTION — Investigational device. Limited by Federal law to investigational use.
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