Pilot Clinical Trial to Assess the Safety of NMS-01 in Patients With Mild to Moderate Alzheimer's Disease

This clinical trial is a single-center, single-arm, open-label, prospective, exploratory study designed to evaluate the safety and efficacy of BBB opening using the NMS-01 focused ultrasound stimulation system in patients with mild-to-moderate Alzheimer's disease receiving standard treatment. The study will be conducted at a single domestic institution with 10 subjects. Safety will be evaluated during the trial by assessing the presence of microhemorrhages and edema at the irradiated site, neurological abnormalities, adverse events, laboratory test results, and electrocardiograms. The efficacy endpoints for demonstrating BBB opening will include the proportion of subjects with successful BBB opening, the BBB opening success rate, the accuracy of the BBB opening location, and BBB recovery. Each subject will undergo a safety evaluations at the end of the procedure, at approximately 24 hours post-procedure, and at 7 days after procedure.