The first US patient to enrol in the ADvance study was successfully implanted with a deep brain stimulation (DBS) system from Functional Neuromodulation. ADvance will 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, for patients with mild Alzheimer’s.
According to a company release, the ADvance study has had six implants conducted to date. The first US implant was done at Johns Hopkins and five patients have been implanted at the Toronto Western Hospital in Canada. The company release also said that the University of Pennsylvania has joined the study, bringing the total to five leading North American research centres participating in ADvance.
“In just two years, we have partnered with expert clinical researchers and assembled a lean team of seasoned professionals that have propelled the company through funding, regulatory requirements, study initiation and significant patient enrollment,” said Todd Langevin, president and COO of Functional Neuromodulation.
“Given the urgent need for progress and the ongoing challenges in drug research for Alzheimer’s, we are excited to assess a completely new circuitry-based approach that could offer hope,” commented David Wolk, assistant professor of Neurology and assistant director of the Penn Memory Center. “Pre-clinical testing has suggested that DBS may result in physiological changes that could alter disease progression. ADvance will help us to determine whether stimulation of the fornix can drive activity in the memory circuit to improve memory and lead to better clinical outcomes.”
ADvance is a randomised double-blind controlled trial initially involving 20 people aged 55-80 with mild Alzheimer’s disease. Patients are currently being recruited to participate in the study at the Banner Alzheimer’s Institute in Phoenix, Johns Hopkins Bayview Medical Center, Toronto Western Hospital, University of Florida Center for Movement Disorders and Neurorestoration and the University of Pennsylvania.
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, tasker chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto and scientific founder of Functional Neuromodulation; and Constantine Lyketsos, Elizabeth Plank Althouse professor, Johns Hopkins University, and director, Johns Hopkins Memory and Alzheimer’s Treatment Center.