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Alzheimer’s Brain Stimulation Implants Completed for Trial

Andres Lozano (University of Toronto)

Andres Lozano (University of Toronto)

30 April 2014. A clinical trial testing the safety and potential benefit of deep brain stimulation to treat Alzheimer’s disease completed implanting stimulation devices in enrolled patients in the U.S. and Canada. Functional Neuromodulation Ltd, in Toronto and Charlottesville, Virginia says it expects to report the first results from the trial in the second quarter of 2015.

Alzheimer’s disease is a progressive, irreversible condition that degrades memory and cognitive skills, with first symptoms usually appearing after age 60. The trial, called ADvance by the company, recruited 42 Alzheimer’s patients, age 45 to 85, with mild cases of the disorder in Toronto, Ontario and sites in Phoenix and Sun City, Arizona, Providence, Baltimore, Philadelphia, and Gainesville, Florida. The study is led by Andres Lozano at University of Toronto and Constantine Lyketsos at Johns Hopkins University, and funded in part by a grant from National Institute on Aging, part of National Institutes of Health.

Deep brain stimulation uses an implanted device similar to a heart pacemaker with electrodes to send mild electrical pulses to specific regions of the brain. The technique is used to treat Parkinson’s disease and dystonia, or involuntary muscle contractions resulting in abnormal repetitive movements or postures. Functional Neuromodulation’s treatment stimulates the fornix, a part of the brain considered a key pathway both in and out of the memory circuit and a region believed to be affected early in the development of Alzheimer’s.

All patients in the clinical trial have a deep brain stimulation device implanted, with half of the group actually receiving stimulation of the fornix, lasting about 12 months. The remainder of the patients serve as a control group, but the company says control group participants will have the stimulation turned on after 12 months.

The study is looking primarily at the safety of the treatments, with any adverse effects from the device or therapy recorded during the 12 months. The trial is also measuring clinical benefits from the treatments. The measures include scores on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, a test to evaluate cognitive functions, and Clinical Dementia Rating scale, as well as changes in glucose metabolism in the brain, an indicator of neural transmission efficiency.

Functional Neuromodulation was founded in 2010 and is backed in part by Medtronic, a maker of deep brain stimulation devices. Andres Lozano, co-director of the ADvance trial, is a scientific founder of the company.

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