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

April 23, 2024 updated by: Sound Wave Innovation CO., LTD.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukuoka, Japan, 814-0001
      • Hiroshima, Japan, 732-0066
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
      • Ōbu, Aichi, Japan, 474-8511
    • Chiba
      • Narita, Chiba, Japan, 286-8520
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
    • Ibaragi
      • Toride, Ibaragi, Japan, 302-0004
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Okayama
      • Kurashiki, Okayama, Japan, 710-0813
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
      • Suita, Osaka, Japan, 564-8565
    • Tochigi
      • Nasushiobara, Tochigi, Japan, 329-2763
        • Recruiting
        • International University of Health and Welfare Hospital
        • Contact:
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan, 113-8655
      • Bunkyō-Ku, Tokyo, Japan, 113-0034
      • Bunkyō-Ku, Tokyo, Japan, 113-0033
        • Recruiting
        • Juntendo University School of Medicine Juntendo Hospital
        • Contact:
      • Itabashi-ku, Tokyo, Japan, 173-0015
    • Tottori
      • Yonago, Tottori, Japan, 683-8504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provide written informed consent to participate in the clinical trial from the patient and their legal representative.
  • Mild AD or MCI due to AD patient aged greater than or equal to (>=) 50 and less than (<) 90 years, at the time of informed consent.

  • Patients with the same partner/informant who meet all of the following conditions during the study period

    • Living with or in contact with the patient
    • It is possible to observe the patient's activities of daily living and physical condition.
    • Being able to be present at all times during the efficacy evaluation specified in this clinical trial
    • Person judged by an investigator to be able to manage administration of concomitant medications
  • Patients who met the diagnostic criteria of Mild AD or MCI due to AD according to the NIA/AA 2018 diagnostic criteria at the time of informed consent and were diagnosed as positive by the amyloid PET imaging evaluation committee.
  • Have a CDR global score of 0.5 (MCI due to AD) to 1.0 (Mild AD) at screening.
  • Patients with her MMSE-J score >=20 at screening.
  • No organic diseases such as symptomatic cerebral hemorrhage, symptomatic cerebral infarction, acute cerebral infarction, brain tumor, etc. within 48 weeks before obtaining informed consent or in head MRI images at screening, and in head MRA images, Patients evaluated by the imaging evaluation committee as not having severe stenosis/occlusion from the internal carotid artery to the middle cerebral artery.
  • Patients who are receiving existing drug therapy for Mild AD or MCI due to AD and are not scheduled to change their medication within the past 4 weeks from obtaining consent and after obtaining consent.

Exclusion Criteria:

  • Patients judged by the investigator that it is difficult to continue the study treatment for 20 minutes.
  • Patients judged by the investigator to be difficult to perform an MRI examination.
  • Patients with impaired consciousness with a GCS score of 12 or less at the time of enrollment.
  • Patients who have had symptomatic cerebral infarction or cerebral hemorrhage within 12 weeks prior to enrollment.
  • Patients with a modified Hachinski Ischemic Scale score of 5 or more at enrollment.
  • Patients with Lewy body dementia and frontotemporal dementia.
  • Patients judged by the investigator to be difficult to participate in the clinical trial due to severe mental illness
  • Poorly controlled serious systemic disease (heart failure, liver failure, renal failure, vitamin B12 deficiency, hypothyroidism, etc.) that makes it difficult for the investigator to participate in the study judged patient.
  • Patients with uncontrolled diabetic retinopathy (with active fundus hemorrhage).
  • Patients who have malignant tumor as a complication or who have been treated for malignant tumor within 5 years from the time of enrollment (excluding cured resected carcinoma in situ).
  • Patients who are or have a history of drug addiction or alcohol addiction.
  • Patients with or with a history of epilepsy.
  • Patients with implants such as coils, electrodes and stents in the skull.
  • Patients within 5 years after brain surgery (including endovascular treatment).
  • Patients who are pregnant or wish to become pregnant.
  • Patients participating in other clinical studies (excluding non-interventional observational studies) or clinical trials.
  • Patients who are otherwise judged to be ineligible by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Device: Placebo
Placebo
Experimental: LIPUS-Brain
Device: LIPUS-Brain
Transcranial low-power pulsed-wave ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in ADAS-J-cog-14 scores from baseline to Week 72
Time Frame: Performed at Week 72
Performed at Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ADAS-J-cog-14 scores from baseline to Week 24 and 48
Time Frame: Performed at Week 24 and 48
Performed at Week 24 and 48
Changes in CDR-SB from baseline to Week 48 and 72
Time Frame: Performed at Week 48 and 72
Performed at Week 48 and 72
Changes in NPIQ-J scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in J-ZBI scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in WMS-R scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in MMSE-J scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in FAQ scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in EQ-5D-5L scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in ABC Dementia scale scores from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Changes in each 14 item of ADAS-J-cog-14 score from baseline to Week 24, 48 and 72
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Prevalence of responders at Week 24, 48, and 72 defined as those with no deterioration or even improvement in ADAS-J-cog-14 scores
Time Frame: Performed at Week 24, 48 and 72
Performed at Week 24, 48 and 72
Transition rate from MCI due to AD to AD at Week 72
Time Frame: Performed at Week 72
Performed at Week 72
Termination due to aggravation of dementia symptoms
Time Frame: Performed up to 96 weeks
If medication needs to be started or changed, dementia is considered worsening.
Performed up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Wave Innovation CO., LTD.

Investigators

  • Study Director: Hiroaki Shimokawa, Sound Wave Innovation CO., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB1101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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