Clinical Trial of Neuromodulation for Alzheimer Disease and Mild Cognitive Impairment Expanded 

Clinical trials of transcranial direct current stimulation (tDCS)(ElectraRx; Soterix Medical, New York, NY) for potential treatment of Alzheimer disease (AD), mild cognitive impairment (MCI), and age-related cognitive decline have been expanded. The study of the proprietary neurostimulation device and software are hoped to be validated as a nondrug therapy to treat diagnosed AD and MCI and to stabilize, possibly even reverse, age-related cognitive decline. 

The Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment trial (NCT02155946) is supported by the National Institutes of Health (NIH) National Institute of Aging (NIA) and sponsored by the Veterans Administration to test high definition tDCS, which can focally target specific brain regions in participants with MCI. The Neurostimulation for Cognitive Enhancement (NICE-AD; NCT04404153) trial is testing at-home tDCS in participants with mild-to-moderate AD. 

The at-home device will also be tested in cognitively healthy individuals over age 65 to evaluate potential benefits of delivering adjunctive tDCS with cognitive training to remediate the trajectory of age-related cognitive decline in the Augmenting Cognitive Training In Older Adults trial (ACT; NCT02851511). 

Mr. Jose Rodriguez, Soterix Medical's vice presidentP 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 AD 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."