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

NCT ID: NCT05983575

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-07-31

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.

Conditions

Alzheimer Disease, Early Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LIPUS-Brain

Group Type: EXPERIMENTAL

LIPUS-Brain

Intervention Type: DEVICE

Transcranial low-power pulsed-wave ultrasound device

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Placebo

Interventions

LIPUS-Brain

Transcranial low-power pulsed-wave ultrasound device

Intervention Type: DEVICE

Placebo

Placebo

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sound Wave Innovation CO., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Shimokawa

Role: STUDY_DIRECTOR

Sound Wave Innovation CO., LTD.

Locations

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

IUHW Narita Hospital

Narita, Chiba, Japan

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, Japan

Imon Yukari Neurology Clinic

Hiroshima, Hiroshima, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Memory Clinic Toride

Toride, Ibaragi, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

KATAYAMA medical Clinic

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

International University of Health and welfare Hospital

Nasushiobara, Tochigi, Japan

Juntendo University School of Medicine Juntendo Hospital

Bunkyō-Ku, Tokyo, Japan

Memory Clinic Ochanomizu

Bunkyō-Ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

Tokyo Metropolitan Geriatrics Hospital

Itabashi-ku, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan

Countries

Japan

References

Shimokawa H, Akishita M, Ihara M, Teramukai S, Ishiki A, Nagai Y, Fukushima M. Pivotal trial of low-intensity pulsed ultrasound therapy for early Alzheimer's disease: Rationale and design. J Alzheimers Dis Rep. 2025 Jan 13;9:25424823241312108. doi: 10.1177/25424823241312108. eCollection 2025 Jan-Dec.

Reference Type: DERIVED

PMID: 40034530 (View on PubMed)

Other Identifiers

LB1101

Identifier Type: -

Identifier Source: org_study_id