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ACTIVE NOT RECRUITING
NCT05983575
PHASE3

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

Sponsor: Sound Wave Innovation CO., LTD.

View on ClinicalTrials.gov

Summary

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.

Official title: A Study to Evaluate the Efficacy and Safety of LIPUS-Brain Transcranial Low-intensity Pulsed-wave Ultrasound Device in Patients With Early Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-10-31

Completion Date

2026-07-31

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DEVICE

LIPUS-Brain

Transcranial low-power pulsed-wave ultrasound device

DEVICE

Placebo

Placebo

Locations (19)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

IUHW Narita Hospital

Narita, Chiba, Japan

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, Japan

Imon Yukari Neurology Clinic

Hiroshima, Hiroshima, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Memory Clinic Toride

Toride, Ibaragi, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

KATAYAMA medical Clinic

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

International University of Health and welfare Hospital

Nasushiobara, Tochigi, Japan

Juntendo University School of Medicine Juntendo Hospital

Bunkyō-Ku, Tokyo, Japan

Memory Clinic Ochanomizu

Bunkyō-Ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

Tokyo Metropolitan Geriatrics Hospital

Itabashi-ku, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan