Enrollment Complete – 42 Patients Implanted in Functional
Neuromodulation’s ADvance Study of Deep Brain Stimulation for
Functional Neuromodulation, Ltd.  has completed enrollment in the ADvance Study . Forty-two North American patients with mild Alzheimer’s have had a deep brain stimulation (DBS) system implanted in this study to evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit. The ADvance Study is the only double-blind randomized and controlled trial and the largest study ever conducted of DBS for Alzheimer’s. Top-line outcomes data are expected in the second quarter of 2015.
Functional Neuromodulation, Ltd. has reached this critical enrollment milestone with remarkable speed. “Thanks to a highly productive partnership with seven leading Alzheimer’s research centers, in less than three years our expert team of professionals has propelled DBS-f for Alzheimer’s through regulatory requirements, study initiation, patient enrollment and implantation,” said Todd Langevin, President and COO of Functional Neuromodulation.
“There is an urgent and growing need for new and better options to treat Alzheimer’s. We are excited to assess a completely new circuitry-based approach that could offer hope. We are especially grateful to the patients and their families who are participating in this important study,” said Dan O’Connell, Functional Neuromodulation co-founder and CEO. “A growing base of pre-clinical and early clinical research suggests that DBS may drive physiological changes in the brain that could ultimately impact disease progression. With top-line data from ADvance expected in a little over a year, we are hopeful that DBS-f will demonstrate safety and therapeutic potential for this devastating disease.”
ADvance is a randomized double-blind controlled trial of patients age 45 to 85 with mild Alzheimer’s disease. The trial compares the effects of DBS-f 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 DBS-f off group will 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 being 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.
The study 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. The study is being supported through a grant from the National Institute on Aging, part of the National Institutes of Health, awarded to Dr. Lyketsos and Dr. Lozano. The NIA/NIH grant is expected to total more than $2 million over five years.
About Deep Brain Stimulation
Deep brain stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. Medtronic, in collaboration with leading physicians around the world, pioneered DBS therapy, which was first approved in Europe in 1995 and in the United States in 1997. The therapy is currently licensed in Canada and approved in other regions, including the European Union and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and chronic intractable primary dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE)1. In Europe, Canada, Australia and Taiwan, DBS therapy is approved for the treatment of refractory epilepsy. The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union, Australia and in the United States under an HDE2. More than 100,000 people worldwide have received Medtronic DBS therapy.
About Functional Neuromodulation, Ltd.
Founded in 2010, Functional Neuromodulation is dedicated to advancing the application of DBS therapies to help improve the lives of people with Alzheimer’s and other memory and cognitive disorders. The Company has received funding from Genesys Capital, Foundation Medical Partners and Medtronic. For more information, visit www.fxneuromod.com .
1 Humanitarian Device in the U.S.: The effectiveness of this
device for the treatment of dystonia has not been demonstrated.
2 Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.
CAUTION — Investigational device.