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

NCT07239310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-12-10

No results posted yet for this 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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Deepsonbio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239310 on ClinicalTrials.gov