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

NCT07239310 | Recruiting

• 2 other identifiers: BIO-Altheon1861
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease(AD)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Neuclare Device

EXPERIMENTAL

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

Sham Device

PLACEBO COMPARATOR

Participants receive standard medication plus sham Neuclare device therapy.

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

Interventions

Participants receive Neuclare Device while continuing their cognitive medication DEVICE

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.

Neuclare Device

Participants receive Sham Neuclare Device while continuing their cognitive medication DEVICE

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.

Sham Device

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 55 to 90 years.
• Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,
• or mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
• On stable cognitive therapy medications for at least 1 month.
• Voluntary participation with signed informed consent.

You may not qualify if:

• Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).
• 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).
• Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
• Patients with a history of severe diseases such as cancer or tuberculosis.
• Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
• Patients with contact dermatitis or other skin hypersensitivity conditions.
• Patients with fever ≥ 40°C as measured by tympanic temperature.
• Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
• Patients unable to undergo MRI.
• Pregnant patients.
• Patients with clinical brain calcification observed on computed tomography (CT) scans.
• Patients with known allergies to contrast agents such as Definity or Gadovist.
• Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.

Sponsors & Collaborators

• Deepsonbio: lead

Study Sites (3)

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sung Kyung Lee

CONTACT

82+10-9877-8173; sklee@deepsonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)