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Clinical trial

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

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Last updated:14th Nov 2023
Status: RECRUITING
Identifier: https://clinicaltrials.gov/study/NCT05983575
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

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