First Patient Implanted in ADvance Study
Functional Neuromodulation Initiates North American Study of Deep Brain Stimulation for Alzheimer’s Disease
Functional Neuromodulation, LtdSusan KleesDirector of Communications434-466-8930
has initiated the ADvance Study in the U.S. and Canada to assess in patients with mild Alzheimer’s disease. ADvance will evaluate the safety and potential clinical benefit of , a major inflow and output pathway in the brain’s memory circuit. Research suggests this is an area affected early in the development of Alzheimer’s. The first ADvance patient enrolled has been successfully implanted.
ADvance is a randomized double-blind controlled trial 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 , 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 , Elizabeth Plank Althouse Professor, Johns Hopkins University, and Director, Johns Hopkins Memory and Alzheimer's Treatment Center. ADvance is currently recruiting patients at Toronto Western Hospital, Johns Hopkins Bayview Medical Center, the Banner Alzheimer’s Institute in Phoenix, AZ and the University of Florida Center for Movement Disorders and Neurorestoration. The study is under institutional review for participation at a few additional leading Alzheimer’s clinical research centers in the U.S.
ADvance is informed by a pilot study of DBS-f in six Alzheimer’s patients conducted at Toronto Western Hospital by Dr. Lozano and his team. A follow-up paper evaluating the relationship between brain metabolism and clinical outcomes in that study was recently published in . That publication reported increased glucose metabolism in key brain networks after stimulation, indicating an increase in neuronal activity and better functional connectivity in areas affected by Alzheimer’s. At one year, this increase in brain metabolism correlated with better outcomes in cognition, memory and quality of life.
“DBS-f delivers stimulation to a critical location in the brain’s memory circuit that seems to enhance activity in the circuit and drive neuronal activity in other brain regions impacted by Alzheimer’s. ADvance will enable us to assess further whether stimulating the brain with DBS-f can drive neural activity in a way that might lead to better clinical outcomes,” commented Dr. Lyketsos, ADvance national co-chair.
“As people are increasingly aware, there is an urgent need for new and better ways to treat Alzheimer’s. DBS is a promising new approach that has a successful track record in a number of other brain disorders,” said , Functional Neuromodulation co-founder and CEO. “We have worked closely with a stellar group of scientific, clinical and regulatory experts to design ADvance as a feasibility study to determine if DBS-f could constitute a new circuitry-based approach to treating this devastating disease. We look forward to expanding the study to more leading Alzheimer’s centers in the U.S.”
Alzheimer’s, the most common form of dementia, is a progressively debilitating disease that ultimately results in death. Today, an estimated 5.9 million North Americans suffer from Alzheimer’s, with the cost to society exceeding $200 billion in this year alone. According to The World Alzheimer Report, 36 million people worldwide are living with dementia, with numbers expected to approximately double every 20 years to 66 million by 2030 and 115 million by 2050. The worldwide costs of dementia (US$604 billion in 2010) amount to more than 1% of global GDP. Alzheimer's is the sixth-leading cause of death and the only cause of death among the top 10 causes in the United States without an identified way to prevent, cure or even slow its progression.
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). In Europe and Canada, 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 and in the United States under an HDE. More than 85,000 people worldwide have received DBS therapy.
Founded in Toronto, Ontario in 2010, is dedicated to advancing the application of deep brain stimulation (DBS) therapies to help improve the lives of people with Alzheimer’s and other memory and cognitive disorders. The Company has received funding from , and . Functional Neuromodulation has entered into a partnership with Medtronic, under which Medtronic is providing its state-of-the-art DBS devices for the ADvance Study and access to Medtronic’s related device regulatory filings. For more information, visit .
Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated. 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. Limited by Federal law to investigational use.