Otawara-shi, Japan Clinical Trials

S Sound Wave Innovation CO., LTD.

A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in patients with Early Alzheimer's Disease. The primary objective of the study is to assess changes in ADAS-J-cog-14 scores from baseline to 72 weeks.