RecruitingNot ApplicableNCT07239310

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

Sponsor

Deepsonbio

Enrollment

138 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment Alzheimer's Disease(AD)

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

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device called Neuclare that delivers gentle electrical stimulation to the brain to temporarily improve thinking and mental sharpness in people with mild cognitive impairment or early-stage Alzheimer's disease. **You may be eligible if...** - You are 55 to 90 years old - You have been diagnosed with probable Alzheimer's disease, mild cognitive impairment (MCI), or very mild Alzheimer's (CDR score 0.5–1) with a memory test score of 18 or above - You have been on stable medications for memory or cognition for at least 1 month - You agree to voluntarily participate and sign the consent form **You may NOT be eligible if...** - Brain imaging shows lesions such as bleeding, stroke, tumors, or vascular abnormalities - You have uncontrolled thyroid problems, low blood sugar, or serious liver/kidney disease - You are taking medications known to impair thinking (such as anticholinergics) - You have a history of seizures, severe psychiatric illness, or other conditions that could interfere with participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEParticipants 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.

DEVICEParticipants 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.