Nexalin Advances Non-Invasive Alzheimer's Therapy Toward FDA Clinical Trials

Reuters2025-12-03
Nexalin Advances Non-Invasive Alzheimer's Therapy Toward FDA Clinical Trials

Nexalin Technology Inc. has announced progress in its research and development efforts for the treatment of Alzheimer's disease. The company recently held a Q-Sub meeting with the FDA, during which they discussed Nexalin's existing clinical data and plans for new U.S.-based pilot studies, followed by a large pivotal study to assess the safety and efficacy of the Gen-2 SYNC console in patients with mild to moderate Alzheimer's disease. Key aspects such as patient population, dosing paradigm, and statistical analysis were aligned upon, and appropriate clinical endpoints were reviewed. The results of these studies have not yet been presented, as Nexalin is currently incorporating FDA feedback into its final pilot study protocol and will provide updates on clinical milestones as appropriate.

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