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

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: Mild Cognitive Impairment; Alzheimer's Disease(AD)
• Intervention / Treatment: Device: Participants receive Neuclare Device while continuing their cognitive medication; Device: Participants receive Sham Neuclare Device while continuing their cognitive medication

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung Kyung Lee; Phone Number: 82+10-9877-8173; Email: sklee@deepsonbio.com

Study Locations

• South Korea
  • Seoul, South Korea, 07985
    • Recruiting
    • Ewha Womans University Mokdong Hospital
    • Contact: Ji Suk Lim; Phone Number: 82+10-2810-1647; Email: jsskin@naver.com
    • Principal Investigator: Gun Ha Kim
  • Gyeonggi-do
    • Hwaseong-si, Gyeonggi-do, South Korea, 18450
      • Not yet recruiting
      • Hallym University Dongtan Sacred Heart Hospital
      • Contact: Ah Jeon Yang; Phone Number: 82+10-2983-5373; Email: hallymhaha@naver.com
      • Principal Investigator: Jae Ho Kim
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Young Sook Ahn; Phone Number: 82+10-9877-6630; Email: hyun717@nate.com
      • Principal Investigator: Sang Yun Kim

Participation Criteria

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 probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,
3. or 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	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

• Sponsor: Deepsonbio

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: BIO-Altheon; 1861 (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