Alzheimer's DiseaseNMSBBBOYUSH01NCT07869238
Pilot Clinical Trial to Assess the Safety of NMS-01 in Patients With Mild to Moderate Alzheimer's Disease
A study testing NMS-01 in people with Alzheimer's Disease and Blood Brain Barrier, run by Neumous Inc. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Blood Brain Barrier
- What is being tested?
- NMS-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Subjects with uncontrolled hypertension or diabetes.
- Subjects with a history of receiving anticoagulant or antiplatelet agents within 2 weeks before or after the application of the investigational medical device, or who are scheduled to receive them.
- Pregnant or lactating women.
- Women of childbearing potential who do not agree to use a clinically appropriate method of contraception for the duration of the clinical trial.
- Subjects currently participating in another clinical trial or who have participated in another clinical trial within 90 days prior to the screening date.
- Any other condition for which the investigator deems participation in the clinical trial to be inappropriate for ethical reasons or because it could influence the trial results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seodaemun, 03722
Neum
WonSeok Jang, MD(Neurosurgery)
About this study
Official title: 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
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
Read the detailed description
This clinical trial is a single-center, single-arm, open-label, prospective, exploratory study designed to evaluate the safety and efficacy of BBB opening using the NMS-01 focused ultrasound stimulation system in patients with mild-to-moderate Alzheimer's disease receiving standard treatment. The study will be conducted at a single domestic institution with 10 subjects. Safety will be evaluated during the trial by assessing the presence of microhemorrhages and edema at the irradiated site, neurological abnormalities, adverse events, laboratory test results, and electrocardiograms. The efficacy endpoints for demonstrating BBB opening will include the proportion of subjects with successful BBB opening, the BBB opening success rate, the accuracy of the BBB opening location, and BBB recovery. Each subject will undergo a safety evaluations at the end of the procedure, at approximately 24 hours post-procedure, and at 7 days after procedure.
- Conditions
- Alzheimer's Disease, Blood Brain Barrier
- Being tested
- NMS-01
- Keywords
- Alzheimer's Disease, BBB Opening
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMS-01Device
BBB opening by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| NMS-01 | Experimental | BBB opening by ultrasound Receives: Device: NMS-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with successful BBB opening (%)
Measured: Change from baseline at 1day and 7day
Proportion of successful BBB opening relative to the number of targets within the application site(%)
Measured: Change from baseline at Day 1 and Day 7
Accuracy of BBB opening location relative to the pre-targeting location(%)
Measured: Time Frame: Change from baseline at Day 1 and Day 7
BBB recovery or not at 24 hours (±6 hours) or 7 days(%)
Measured: Time Frame: Change from baseline at Day 1 and Day 7
Adverse events recording
Measured: up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start5 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Allocation N/A Single Group Assignment Masking None (Open Label)
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neumous Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869238
- Sponsor's protocol ID
- NMS-BBBO-YUSH-01
- Acronym
- NMSBBBOYUSH01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07869238
- Acronym / sponsor ID
- NMSBBBOYUSH01 / NMS-BBBO-YUSH-01
- Conditions
- Alzheimer's Disease, Blood Brain Barrier
- Keywords
- Alzheimer's Disease, BBB Opening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Neumous Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This clinical trial is a single-center, single-arm, open-label, prospective, exploratory study designed to evaluate the safety and efficacy of BBB opening using the NMS-01 focused ultrasound stimulation system in patients with mild-to-moderate Alzheimer's disease receiving standard treatment. The study will be conducted at a single domestic institution with 10 subjects. Safety will be evaluated during the trial by assessing the presence of microhemorrhages and edema at the irradiated site, neurological abnormalities, adverse events, laboratory test results, and electrocardiograms. The efficacy endpoints for demonstrating BBB opening will include the proportion of subjects with successful BBB opening, the BBB opening success rate, the accuracy of the BBB opening location, and BBB recovery. Each subject will undergo a safety evaluations at the end of the procedure, at approximately 24 hours post-procedure, and at 7 days after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Allocation N/A Single Group Assignment Masking None (Open Label)
| Arm | Type | Receives |
|---|---|---|
| NMS-01 | Experimental | Device: NMS-01BBB opening by ultrasound |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMS-01BBB opening by ultrasound | Device | NMS-01 |
Primary outcome
Proportion of subjects with successful BBB opening (%)
Time frame: Change from baseline at 1day and 7day
Proportion of successful BBB opening relative to the number of targets within the application site(%)
Time frame: Change from baseline at Day 1 and Day 7
Accuracy of BBB opening location relative to the pre-targeting location(%)
Time frame: 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: Time Frame: Change from baseline at Day 1 and Day 7
Adverse events recording
Time frame: up to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMS-01 in people with Alzheimer's Disease and Blood Brain Barrier, run by Neumous Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lim Michael Team leader (+82-70-7789-2558, info@neumous.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with successful BBB opening (%) (time frame: Change from baseline at 1day and 7day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.