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

NCT05983575 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-05-15

No results posted yet for this study

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

  • Alzheimer Disease, Early Onset

Interventions

DEVICE

LIPUS-Brain

Transcranial low-power pulsed-wave ultrasound device

DEVICE

Placebo

Placebo

Sponsors & Collaborators

  • Sound Wave Innovation CO., LTD.

    lead INDUSTRY

Principal Investigators

  • Hiroaki Shimokawa · Sound Wave Innovation CO., LTD.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2026-01-31
Completion
2026-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983575 on ClinicalTrials.gov