Sound Wave Innovation CO., LTD. (Head Office: Chuo-ku, Tokyo; Chairman of the Board: Hiroaki Shimokawa, MD, PhD; https://sw-innovation.com/) has achieved the target number (N=220) of enrolled patients in the “LIPUS-Brain Trial to evaluate the efficacy and safety of transcranial low-intensity pulsed ultrasound therapy for patients with early Alzheimer’s disease (Clinical trial protocol number: LB1101, Clinical research protocol number: jRCT2032230125)”, which began in October 2023.

This is a multicenter study to evaluate the efficacy and safety of LB1101 in patients with early Alzheimer’s disease (AD) and mild cognitive impairment (MCI) due to AD, with a target completion date of the end of 2026.

Although various adjustments were required in conducting the clinical trial, including the fact that this is the first medical device for dementia treatment in Japan, we were able to achieve smooth case enrollment with the cooperation of related organizations, 19 participating medical institutions nationwide, and the patients and families of the subjects. We will analyze the clinical trial data collected and proceed with the application process for regulatory approval.

In September 2022, this medical device was designated as the first “pioneering medical device” by the Ministry of Health, Labour and Welfare in recognition of its novelty, efficacy, and resolution of social issues.

Contact :
Sound Wave Innovation Co., Ltd.
mail：info@sw-innovation.com