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Clinical Trials in South Korea / NCT07239310
Recruiting Not applicable

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

NCT07239310 · tracked via the Priya Life Science South Korea tracker
Sponsor
Deepsonbio
Phase
Not applicable
Started
2025-11-20
Last updated
2026-08-07

Condition(s) studied

Mild Cognitive ImpairmentAlzheimer's Disease(AD)

Investigational drug(s) / intervention(s)

Participants receive Neuclare Device while continuing their cognitive medicationParticipants receive Sham Neuclare Device while continuing their cognitive medication

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Trail Making Test-A Completion Time from Baseline to Week 5 — 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.

Trial sites (7)

FacilityCityRegionStatus
Soonchunhyang University Cheonan Hospital Cheonan Chungcheongnam-do Recruiting
Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Gyeonggi-do Recruiting
Inha University Hospital Incheon Gyeonggi-do Recruiting
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Recruiting
The Catholic University of Korea, St. Vincent's Hospital Suwon Gyeonggi-do Recruiting
Ewha Womans University Seoul Hospital Seoul South Korea Recruiting
Ewha Womans University Mokdong Hospital Seoul South Korea Recruiting

Other trials for the same condition

Evaluation of Cerogrin for Auricular Vagus Nerve Stimulation in Vascular Dementia or Vascular Mild Cognitive Impairment Active, not recruiting
Development of Pressure Sensor Based Dementia and Fall Prevention Program for Older Adults Recruiting
Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ) Recruiting
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2 (KBASE2) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07239310 on ClinicalTrials.gov ↗ ← All trials in South Korea