NEW YORK, Dec. 24, 2020 /PRNewswire/ -- Soterix Medical Inc. , the global leader in non-invasive stimulation and synergistic brain imaging technologies, is pleased to report expanded clinical trials of its proprietary neuromodulation technologies for Alzheimer's disease and Mild Cognitive Impairment. Adults over age 65 represent the fastest growing population in the US. Decline in cognitive abilities is a hallmark of advanced age and is associated with loss of independence and dementia risk. Over 50 million adults worldwide are diagnosed with Alzheimer's disease or other dementia, which puts an enormous burden on individuals, their families and caretakers, and the healthcare system. Soterix Medical technologies are at the forefront of validation of non-invasive non-drug therapies not simply to both treat diagnosed Alzheimer's disease and Mild Cognitive Impairment but also stabilize, and even reverse, age-related cognitive decline.
With $6.2 million of support from the National Institutes of Health (NIH) National Institute of Aging (NIA), the Albert Einstein College of Medicine, Montefiore Health System, and the MJHS Health System will evaluate the effectiveness of tDCS to alleviate symptoms of Alzheimer's disease and improve brain function. This new trial will leverage Soterix Medical's unique at-home tDCS platform, the mini-CT stimulator and ElectraRx™ remote control software. The randomized, double-blind study will evaluate the effects of six months of at-home tDCS on improving cognitive performance and selected symptoms in 100 patients with mild-to-moderate Alzheimer's disease.
Since 2016, the NIH NIA has provided $5.7 million University of Florida Health and the University of Arizona, to test the efficacy of Soterix Medical's tDCS platform in slowing the process of age-associated memory loss and potentially prevent onset of dementia. The 360 participant Augmenting Cognitive Training in Older Adults (ACT Study) is a Phase III definitive multi-site randomized clinical trial to establish the benefit of delivering adjunctive tDCS with cognitive training in older adults to remediate the trajectory of age-related cognitive decline.
The Veteran's Administration and NIH are supporting two double-blind, randomized controlled trials in patients with mild cognitive impairment (146 subjects) or Alzheimer's disease (100 subjects) using Soterix Medical's proprietary High-Definition tDCS, a form of tDCS that can focally target brain regions.
Mr. Jose Rodriguez, Soterix Medical's VP Regulatory Affairs, explains "Soterix Medical is enthusiastic to support our medical partners around the world in conducting the most rigorous clinical trials for non-invasive neuromodulation in Alzheimer's disease and Mild Cognitive Impairment. We feel the funding support for these trials from government agencies such as the NIH and VA further supports their rigor and importance. And with the inclusion of state-of-the-art biomarkers testing, these trials can not only demonstrate efficacy, but prove target engagement."
Dr. Abhishek Datta, CTO of Soterix Medical adds, "The application of unique Soterix Medical technology to develop treatments for age-related cognitive decline demonstrates the versatile capabilities of our platforms. These include Soterix Medical SNAPpad™ and HD electrodes, by far the most successful and trusted tDCS electrodes, our capabilities to support the most controlled double-bind trials, and to provide unique delivery platforms both at medical centers and at-home."
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
Media Contact: Mariana Shuster
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SOURCE Soterix Medical Inc.