Pilot Clinical Trial to Assess the Safety of NMS-01 in Patients With Mild to Moderate Alzheimer's Disease

NCT07869238 | Recruiting

• 1 other identifier: NMS-BBBO-YUSH-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, single-arm, prospective, open-label, pilot clinical trial to evaluate the safety and efficacy of the Focused ultrasound stimulator system (NMS-01) for transient Blood-Brain Barrier (BBB) opening in patients with mild to moderate Alzheimer's disease

Conditions

Alzheimer's Disease; Blood Brain Barrier

Keywords

Alzheimer's Disease; BBB Opening

Outcome Measures

Primary Outcomes (5)

• Proportion of subjects with successful BBB opening (%)

  Change from baseline at 1day and 7day

• Proportion of successful BBB opening relative to the number of targets within the application site(%)

  Change from baseline at Day 1 and Day 7

• Accuracy of BBB opening location relative to the pre-targeting location(%)

  Time Frame: Change from baseline at Day 1 and Day 7

• BBB recovery or not at 24 hours (±6 hours) or 7 days(%)

  Time Frame: Change from baseline at Day 1 and Day 7

• Adverse events recording

  up to Day 7

Study Arms (1)

NMS-01

EXPERIMENTAL

BBB opening by ultrasound

Device: NMS-01

Interventions

NMS-01 DEVICE

BBB opening by ultrasound

NMS-01

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 50 to 85 years, inclusive.
• Individuals previously diagnosed with probable Alzheimer's Disease (AD) by a specialist according to the National Institute on Aging and Alzheimer's Association (NIA-AA) 2011 criteria.
• Individuals with a previously confirmed positive 18F-Florbetaben (FBB) position emission tmography (PET) scan.
• Individuals with a Clinical Dementia Rating (CDR) global score between 1 and 2, inclusive.
• Individuals with a total score on the Korean version of the Mini-Mental State Examination (K-MMSE) between 12 and 26, inclusive.
• Individuals who have been on a stable dose and regimen of approved medications for the treatment of Alzheimer's disease for at least 3 months prior to screening.
• Individuals capable of expressing sensations or discomfort to the investigator during the procedure.
• Availability of a caregiver or informant who either lives with the participant or has sufficient contact (averaging at least 10 hours per week) to provide reliable information about the participant's overall functioning. This person must be able to accompany the participant to clinic visits, actively participate in clinical trial procedures, including interviews and questionnaire completion, and must voluntarily provide written informed consent for their own participation.
• Participants (or their legally authorized representatives) must provide voluntary written informed consent for participation in the clinical trial. If a participant is illiterate and unable to provide written consent, verbal consent is permissible but must be formally documented. Furthermore, as all participants are considered vulnerable subjects, consent must also be provided and signed by a legal representative.

You may not qualify if:

• A severity score greater than 2 on any one of the following items on the Caregiver Administered Neuropsychiatry Inventory (CGA-NPI): "Delusions," "Hallucinations," or "Agitation/Aggression."
• An uncontrolled psychiatric disorder/condition that could affect cognitive function or its assessment (e.g., schizophrenia, bipolar disorder, major depression). (However, subjects are permitted if they have been on a stable drug regimen without changes in dosage for at least the past 4 weeks).
• Subjects with pulmonary disease (e.g., pneumonia, pulmonary edema) confirmed by chest X-ray.
• Subjects with a known sensitivity, allergy, or contraindication to MRI contrast agents (Gadovist® injection) or ultrasound contrast agents (SonoVue®).
• Subjects with standard contraindications for MR imaging, such as the presence of MRI-incompatible metallic implants.
• Subjects with a known sensitivity, allergy, or contraindication to local anesthetics or anesthetic agents used for conscious sedation during the procedure, if required.
• Subjects meeting any of the following criteria based on MRI findings:
• More than 30% of the skull area in the intended ultrasound sonication path is covered by scar tissue, scalp disorders (e.g., eczema), or atrophied scalp.
• A history of bleeding disorders.
• Significant cardiac disease or unstable hemodynamic status (e.g., uncontrolled hypertension, arrhythmia, angina pectoris, etc.).
• Subjects with impaired renal function (Glomerular filtration rate \<30 mL/min/1.73 m²).
• Severe brain atrophy that would preclude targeting.
• Subjects who are HIV (Human Immunodeficiency Virus) positive and are at high risk of HIV encephalitis due to the influx of HIV into the brain parenchyma.
• Subjects with a potential blood-borne infection that could enter the brain parenchyma and lead to meningitis or a brain abscess.
• Subjects with clinically significant abnormal findings on an electrocardiogram (ECG).

Sponsors & Collaborators

• Neumous Inc.: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Lim Michael Team leader

CONTACT

+82-70-7789-2558; info@neumous.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation N/A Single Group Assignment Masking None (Open Label)

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: October 9, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-08

Locations

KR (1)