Functional Neuromodulation has completed enrolment for the Advance study. Forty-two North American patients with mild Alzheimer’s have had a deep brain stimulation system implanted to evaluate the safety and potential clinical benefit of deep brain stimulation of the fornix.
The Advance study, according to a press release, is the only double-blind, randomised controlled trial and the largest study ever conducted of deep brain stimulation for Alzheimer’s. Top-line outcomes data are expected in the second quarter of 2015.
“Thanks to a highly productive partnership with seven leading Alzheimer’s research centres, in less than three years our expert team of professionals has propelled deep brain stimulation of the fornix for Alzheimer’s through regulatory requirements, study initiation, patient enrolment and implantation,” says 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,” adds Dan O’Connell, Functional Neuromodulation co-founder and CEO. “A growing base of pre-clinical and early clinical research suggests that deep brain stimulation 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 deep brain stimulation of the fornix will demonstrate safety and therapeutic potential for this devastating disease.
About the Advance study
Advance is a randomised, double-blind controlled trial of patients aged 45–85 with mild Alzheimer’s disease. The trial compares the effects of deep brain stimulation of the fornix turned on to those observed with the system turned off. The patients are expected to undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the stimulation-off group will have the system activated. Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory are also said to be assessed at multiple time points.
Advance is being conducted at seven leading research centers in North America: Banner Alzheimer’s Institute in Phoenix, USA; Banner Sun Health Research Institute in Sun City, USA; Butler Hospital and Rhode Island Hospital in Providence, USA; Johns Hopkins Bayview Medical Center in Baltimore, USA; Toronto Western Hospital in Toronto, Canada; University of Florida Center for Movement Disorders and Neurorestoration in Gainesville, USA; and the University of Pennsylvania in Philadelphia, USA.
The study is co-chaired by Andres Lozano, tasker chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto, Canada, and Scientific Founder of the company and Constantine Lyketsos, MD, Elizabeth Plank Althouse professor, Johns Hopkins University, and director, Johns Hopkins Memory and Alzheimer’s Treatment Center, USA. The study is being supported through a grant from the National Institute on Aging, part of the National Institutes of Health, awarded to Lyketsos and Lozano. The NIA/NIH grant is expected to total more than US$2 million over five years.
The device used in the study is an investigational device only and is limited by federal law to investigational use.