Functional Neuromodulation Initiates Pivotal Clinical Trial of Deep Brain Stimulation for Alzheimer's Disease

MINNEAPOLIS, Sept. 10, 2019 /PRNewswire/ -- Functional Neuromodulation has initiated the global ADvance II Study, a pivotal clinical trial to assess deep brain stimulation (DBS) in patients with mild Alzheimer's Disease. The study will evaluate the safety and efficacy of stimulation of the fornix (DBS-f)—a major inflow and output pathway in the brain's memory circuit.  Research suggests that this is an area affected early in the development of Alzheimer's. The ADvance II study is being conducted in the United States, Canada and Germany.

The ADvance II study is a randomized, double-blind, controlled trial involving up to 210 people 65 years or older with mild Alzheimer's disease.  The first patient was enrolled by Anna Burke, M.D., director of the Alzheimer's and Memory Disorders Division at Barrow Neurological Institute and Francisco Ponce, M.D., Director of the Center for Neuromodulation at Barrow.  The study is using the Boston Scientific Vercise^™ Directional System, which is designed to precisely stimulate the pathway in the brain's memory circuit.  

Alzheimer's disease, the most common form of dementia, is a progressively debilitating disease that ultimately results in death. Today, over 30 million people worldwide suffer from Alzheimer's disease, with the cost to society around a trillion US dollars a year. That cost is expected to double by 2030¹. Alzheimer's disease 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.

"There is an urgent need for new ways to treat Alzheimer's.  Pharmacological therapies have shown very limited benefit, and some have considerable side effects.  DBS is a promising alternative with a safe and successful track record in other neurological disorders.  Based on encouraging results from the feasibility trial, we have worked closely with a stellar group of scientific, clinical and regulatory experts to design ADvance II to determine if DBS-f could be a new circuitry-based approach to treating this devastating disease," said Todd Langevin, Functional Neuromodulation CEO. 

The ADvance II study is based on the results of the previous ADvance study that suggested beneficial effects of DBS-f in patients 65 years or older.

"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.  The ADvance II study will enable us to assess whether stimulating the brain with DBS-f can drive neural activity in a way that might lead to better clinical outcomes," commented Dr Burke.

About the ADvance II Study
The study is co-chaired by Constantine Lyketsos, M.D., chair of psychiatry at Johns Hopkins Bayview Medical center and Andres Lozano, M.D., Ph.D., chair of neurosurgery at the University of Toronto.  For more information about the ADvance II Study, visit www.fxneuromod.com or www.advancestudy4ad.com.  

The clinical trial is currently enrolling subjects at 14 study sites within the United States, Canada and Germany.  Cities include Cologne, Kiel, Würzburg, Magdeburg, Berlin and Munich in Germany, Phoenix AZ, Los Angeles CA, Gainesville and Tampa FL, Austin TX and Stanford CA, Baltimore MD in the United States, and Toronto, ON, Canada.

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.  DBS therapy has been commercially available in the United States since 1997.  The therapy is currently approved for use in the United States, Canada and the European Union for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and epilepsy. More than 150,000 people worldwide have received DBS therapy.

The data from Advance II study is intended to support U.S. regulatory application.  In Europe, Boston Scientific Vercise™ Directional System is CE marked for adjunctive treatment of patients 65 year and older with mild probable Alzheimer's disease.

About Functional Neuromodulation Ltd.
Founded in 2010, Functional Neuromodulation 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 Genesys Capital, Foundation Medical Partners and Boston Scientific.

Contact person: Robyn Moxon, [email protected], 1-866-296-4040 

¹ Alzheimer's Disease International (September 2018) World Alzheimer's Report 2018
Retrieved from https://www.alz.co.uk/research/WorldAlzheimerReport2018.pdf

CAUTION — Investigational device. Limited by Federal law to investigational use.

SOURCE Functional Neuromodulation Ltd.

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