Trials / Active Not Recruiting
Active Not RecruitingNCT05983575
A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- Sponsor
- Sound Wave Innovation CO., LTD. · Industry
- Sex
- All
- Age
- 50 Years – 89 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LIPUS-Brain | Transcranial low-power pulsed-wave ultrasound device |
| DEVICE | Placebo | Placebo |
Timeline
- Start date
- 2023-10-31
- Primary completion
- 2026-01-31
- Completion
- 2026-07-31
- First posted
- 2023-08-09
- Last updated
- 2025-05-15
Locations
19 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05983575. Inclusion in this directory is not an endorsement.