Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease

August 5, 2026 updated by: Deepsonbio

A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Confirmatory Clinical Trial to Verify the Efficacy and Safety of the Cognitive Improvement Effect on Executive Function in Medication-Treated Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease Using the Neuclare Physical Device for Medical Use

This study is a multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's disease.

Participants will continue their current medication and be randomly assigned to receive either the Neuclare device (treatment group) or a sham device (control group). The device will be applied to the brain three times per week for four weeks. Both participants and study staff are blinded to the group assignment. Safety and adverse events will be closely monitored throughout the study.

During the trial, assessments will include attention, cognitive function, daily living activities, brain imaging (Amyloid PET-CT), blood biomarkers, and quality of life (EQ-5D-5L).

The goal of this study is to determine whether the Neuclare device, in combination with standard medication, can safely provide temporary improvements in executive function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

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

  • South Korea
      • Seoul, South Korea, 07985
        • Recruiting
        • Ewha Womans University MokDong Hospital
        • Contact:
        • Principal Investigator:
          • Gun Ha Kim
      • Seoul, South Korea, 07804
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
        • Principal Investigator:
          • Ji Hyang Jeong
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, South Korea, 31151
        • Recruiting
        • Soonchunhyang University Cheonan Hospital
        • Contact:
        • Principal Investigator:
          • Young Soon Yang
    • Gyeonggi-do
      • Hwaseong-si, Gyeonggi-do, South Korea, 18450
        • Recruiting
        • Hallym University Dongtan Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Jae Ho Kim
      • Incheon, Gyeonggi-do, South Korea, 22332
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Sung Hye Choi
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Jung Min Pyun
      • Suwon, Gyeonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
        • Contact:
        • Principal Investigator:
          • Yong Soo Shim

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:

  1. Adults aged 55 to 90 years.
  2. Diagnosed with mild cognitive impairment (MCI) or early Alzheimer's disease according to the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
  3. mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
  4. On stable cognitive therapy medications for at least 1 month.
  5. Voluntary participation with signed informed consent.

Exclusion Criteria:

  1. Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).
  2. Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs).
  3. Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
  4. Patients with psychiatric disorders outside of the inclusion criteria.
  5. Patients with a history of severe diseases such as cancer or tuberculosis.
  6. Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
  7. Patients with contact dermatitis or other skin hypersensitivity conditions.
  8. Patients with fever ≥ 40°C as measured by tympanic temperature.
  9. Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
  10. Patients unable to undergo MRI.
  11. Pregnant patients.
  12. Patients with clinical brain calcification observed on computed tomography (CT) scans.
  13. Patients with known allergies to contrast agents such as Definity or Gadovist.
  14. Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.

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
Experimental: Neuclare Device
Participants receive standard medication plus Neuclare device therapy three times per week for 4 weeks.
Device: Participants receive Neuclare Device while continuing their cognitive medication

Participants in this arm receive the Neuclare physical device applied to the cerebral cortex, receiving low-intensity ultrasound stimulation less than 30 minutes per session, three times per week for 4 weeks.

This intervention is intended to temporarily improve executive function in patients with mild cognitive impairment and prodromal Alzheimer's disease.
Placebo Comparator: Sham Device
Participants receive standard medication plus sham Neuclare device therapy.
Device: Participants receive Sham Neuclare Device while continuing their cognitive medication

Participants in this arm receive a sham version of the Neuclare device, which mimics the appearance and procedure of the active device but does not deliver therapeutic ultrasound.

The sham device is applied less than 30 minutes per session, three times per week for 4 weeks, while participants continue their cognitive medication.

This arm serves as a control for comparison with the active intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Trail Making Test-A Completion Time from Baseline to Week 5
Time Frame: 5 weeks
The primary efficacy outcome is the change in Trail Making Test-A (TMT-A) completion time from baseline to Week 5 after application of the investigational device. Descriptive statistics will be presented for each treatment arm. Between-group comparisons of the change from baseline will be analyzed using ANCOVA with baseline scores as a covariate.
5 weeks

Collaborators and Investigators

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

Sponsor

Deepsonbio

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)

November 20, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-Altheon
  • 1861 (Other Identifier: Ministry of Food and Drug Safety (MFDS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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