NCT05983575 — A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
Key Information
| Field | Value | |-------|-------| | Phase | Phase 3 | | Status | Active, not recruiting | | Enrollment | 220 participants (estimated) | | Sponsor | Sound Wave Innovation CO., LTD. | | Study Type | Interventional | | Design | Randomized, double-blind, placebo-controlled | | Start Date | October 31, 2023 | | Primary Completion | January 31, 2026 (estimated) | | Completion | July 31, 2026 (estimated) |
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Trial Overview
Mermaid diagram (expand to render)
NCT05983575 — A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
Key Information
| Field | Value | |-------|-------| | Phase | Phase 3 | | Status | Active, not recruiting | | Enrollment | 220 participants (estimated) | | Sponsor | Sound Wave Innovation CO., LTD. | | Study Type | Interventional | | Design | Randomized, double-blind, placebo-controlled | | Start Date | October 31, 2023 | | Primary Completion | January 31, 2026 (estimated) | | Completion | July 31, 2026 (estimated) |
Study Description
This 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 is to assess changes in ADAS-J-cog-14 scores from baseline to 72 weeks.
Mechanism of Action
LIPUS-Brain delivers transcranial low-intensity pulsed-wave ultrasound to the brain. The mechanism is believed to involve:
J-ZBI (Japanese version of Zarit Burden Interview)
WMS-R (Wechsler Memory Scale-Revised)
MMSE-J (Japanese MMSE)
FAQ (Functional Activities Questionnaire)
EQ-5D-5L quality of life
ABC Dementia scale
Response rate (% with no deterioration or improvement in ADAS-J-cog-14)
Transition rate from MCI due to AD to AD
Study Sites (Japan)
Nagoya University Hospital (Nagoya)
National Center for Geriatrics and Gerontology (Obu)
IUHW Narita Hospital (Narita)
Fukuoka Sanno Hospital (Fukuoka)
Sapporo Medical University Hospital (Sapporo)
Kanazawa University Hospital (Kanazawa)
Tohoku University Hospital (Sendai)
Niigata University Medical and Dental Hospital (Niigata)
Kansai Medical University Hospital (Hirakata)
National Cerebral and Cardiovascular Center (Suita)
Juntendo University Hospital (Tokyo)
The University of Tokyo Hospital (Tokyo)
Tokyo Metropolitan Geriatrics Hospital (Tokyo)
Rationale and Design
The trial rationale and design were published by Shimokawa et al. in [J Alzheimers Dis Rep 2025](https://pubmed.ncbi.nlm.nih.gov/40034530/). The baseline characteristics of enrolled patients were subsequently reported in [J Alzheimers Dis Rep 2025](https://pubmed.ncbi.nlm.nih.gov/41477670/).
Related Pages
[Focused Ultrasound](/therapeutics/focused-ultrasound) — Overview of focused ultrasound therapeutic applications
[Alzheimer's Disease Clinical Trials](/clinical-trials/alzheimers-disease) — Index of AD trials
[Non-Pharmacological Therapies](/therapeutics/non-pharmacological-therapies-alzheimer) — Other non-pharmacological approaches
References
[Shimokawa et al., Baseline characteristics of patients with early Alzheimer's disease enrolled in the pivotal trial of low-intensity pulsed ultrasound (LIPUS-AD). J Alzheimers Dis Rep (2025)](https://pubmed.ncbi.nlm.nih.gov/41477670/)
[Shimokawa et al., Pivotal trial of low-intensity pulsed ultrasound therapy for early Alzheimer's disease: Rationale and design. J Alzheimers Dis Rep (2025)](https://pubmed.ncbi.nlm.nih.gov/40034530/)