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A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
Sponsor: Sound Wave Innovation CO., LTD.
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
Conditions
Interventions
LIPUS-Brain
Transcranial low-power pulsed-wave ultrasound 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