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

Alzheimer Disease, Early Onset Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983575
• Other study ID #: LB1101
• Status: Recruiting
• Phase: Phase 3
• Start date: October 31, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: Sound Wave Innovation CO., LTD.
• Contact: Sound Wave Innovation CO., LTD.
• Phone: +81-3-6661-2457
• Email: Lipus-brain-trial[@]sw-innovation.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

Device:
• LIPUS-Brain
Transcranial low-power pulsed-wave ultrasound device
• Placebo
Placebo

Locations

Country	Name	City	State
Japan	Juntendo University School of Medicine Juntendo Hospital	Bunkyo-Ku	Tokyo
Japan	Memory Clinic Ochanomizu	Bunkyo-Ku	Tokyo
Japan	The University of Tokyo Hospital	Bunkyo-Ku	Tokyo
Japan	Fukuoka Sanno Hospital	Fukuoka
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Imon Yukari Neurology Clinic	Hiroshima
Japan	Tokyo Metropolitan Geriatrics Hospital	Itabashi-ku	Tokyo
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	KATAYAMA medical Clinic	Kurashiki	Okayama
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	IUHW Narita Hospital	Narita	Chiba
Japan	International University of Health and welfare Hospital	Nasushiobara	Tochigi
Japan	National Center for Geriatrics and Gerontology	Obu	Aichi
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka
Japan	Memory Clinic Toride	Toride	Ibaragi
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
Sound Wave Innovation CO., LTD.

Country where clinical trial is conducted

Japan, 

Outcome

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