A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT05983575
Sponsor: Sound Wave Innovation CO., LTD.
Information provided by: Sound Wave Innovation CO., LTD. (Responsible Party)
Last Update Posted: 2023-11-15
Brief 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
Intervention / Treatment:
- Device: LIPUS-Brain
- Device: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-10-31 |
| Primary Completion (Estimated) | 2026-01-31 |
| Study Completion (Estimated) | 2026-07-31 |
| Enrollment (Estimated) | 220 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
LB1101
|