Functional Neuromodulation for Alzheimer’s Begins Trial

Functional Neuromodulation for Alzheimer’s Begins Trial

Functional Neuromodulation, a medical technology company, develops neuromodulation technologies for cognitive and memory disorders. It offers deep brain stimulation therapies for Alzheimer’s disease and mild cognitive impairment. The company was founded in 2010 and is based in Toronto, Canada.

Description

Functional Neuromodulation Inc. is advancing the application of deep brain stimulation (DBS) therapies to improve the lives of people with Alzheimer’s and other memory and cognitive disorders. DBS uses a surgically implanted medical device to deliver mild electrical pulses to precisely targeted areas of the brain. Functional Neuromodulation has completed a $10.4M round of financing and has partnered with Medtronic, the pioneer of DBS technology; although DBS has been an effective treatment for movement disorders for over 15 years, it has only recently been applied to Alzheimer’s. Functional Neurotechnology is investigating the usage of DBS of the fornix (DBS-f) to drive neural activity and modulate the brain’s memory circuit. The fornix is a major inflow and output pathway in the brain’s memory circuit, and is one of the first areas of the brain affected by Alzheimer’s; thus, DBS of this structure may drive critical neural activity and modulate the memory circuit in patients with early Alzheimer’s. This earlier-stage medical device company expects to begin a Phase II multi-center clinical trial of DBS-f in patients with mild probable Alzheimer’s in 2012.

Company Overview

Functional Neuromodulation, Ltd. engages in the application of deep brain stimulation therapies for people with Alzheimer’s, and various other memory and cognitive disorders. The company focuses on assessing the safety and clinical benefits of deep brain stimulation of the fornix in patients with mild Alzheimer’s disease in the United States and Canada. Functional Neuromodulation, Ltd. was founded in 2010 and is based in Toronto, Canada.

Two Devices Treat Alzheimer’s

Pharmaceutical companies developing Alzheimer’s drugs have faced one hurdle after another. The most effective treatments are difficult to get into the brain, while those that show success in animals have yet to benefit humans.

Two startup companies aim to solve these problems by targeting the brain electrically rather than chemically. They’re both using technologies that have proven successful for other brain disorders. One company plans to use deep brain stimulation, which has been used to treat tens of thousands of Parkinson’s patients. The other hopes to find success with transcranial magnetic stimulation, a noninvasive approach used to treat depression and as a research tool to stimulate or inhibit specific parts of the brain.

In deep brain stimulation, electrical pulses are delivered to a dysfunctional part of the brain via a surgically implanted electrode, stimulating neural activity. The technology is being used or tested for a growing number of disorders, including medication resistant epilepsy, depression, and obsessive compulsive disorder. Neurosurgeon Andres Lozano, at the University of Toronto, became interested in its potential for treating Alzheimer’s thanks to an unexpected finding published in 2008. Researchers were testing to see if they could help a morbidly obese patient lose weight by stimulating a part of the brain that governs satiety. Follow-up tests revealed that the patient showed a significant improvement in memory.

Brain imaging revealed that the obesity treatment activated various brain structures involved in memory. Such structures have typically deteriorated in Alzheimer’s patients, and Lozano’s idea is to use deep brain stimulation to boost activity in the memory circuits that patients have left. Late last year, Lozano formed startup Functional Neuromodulation with Daniel O’Connell, founder of Neuroventures and now its CEO, to commercialize the technology.

It’s still unclear how well the approach will work in people with the neurodegenerative disorder. A small study published last fall showed mixed results. The treatment appeared to slow cognitive decline in a few patients, but had no effect in others. However, researchers did find that deep brain stimulation reversed one of the markers of Alzheimer’s: impaired glucose metabolism in the brain. Preliminary evidence suggests that it is more effective when used at earlier stages of the disease.

About Alzheimer’s Disease

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 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.

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 deep brain stimulation therapy, which was first approved in Europe in 1995 and the United States in 1997. More than 80,000 people worldwide have received Medtronic DBS Therapy.

Since this initial finding, Dr. Lozano and colleagues at Toronto Western Hospital completed a Phase I pilot study to test the safety and potential cognitive benefit of DBS in the fornix (DBS-f) in mild Alzheimer’s patients. The DBS target in Alzheimer’s, the fornix, is a large arch-like bundle of 1.2 million axons that connects the hippocampus to other parts of the limbic system, a group of interconnected structures in the brain that mediate emotions, learning and memory. The fornix is a major inflow and output pathway in the brain’s memory circuit and is one of the first areas of the brain affected by Alzheimer’s. With the fornix critical to memory function, DBS of this structure may drive critical neural activity.

The results from the pilot study in six patients indicate that DBS-f may drive neural activity and modulate the memory circuit in patients with early Alzheimer’s. While patients in this pilot study remained on medication during DBS treatment, based on the results of this trial, researchers hypothesize DBS-f may slow the rate of cognitive decline over 12 months relative to the expected rate of change in mildly impaired patients. Study data also show that DBS-f may produce improvement in glucose metabolism in brain areas associated with Alzheimer’s, possibly indicating an increase in energy utilization and function of these areas. The researchers conclude that memory circuits can be safely accessed with DBS. The study was published in the Annals of Neurology in 2010.

A follow-up paper evaluating the relationship between brain metabolism and clinical outcomes in that study was recently published in Archives of Neurology. 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.

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