Actively Recruiting
Neuclare Device to Improve Executive Function in Adults With Mild Cognitive Impairment and Early Alzheimer's Disease: A Multicenter, Randomized, Double-Blind Clinical Trial
Led by Deepsonbio · Updated on 2025-12-10
138
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the Neuclare medical device to see if it can temporarily improve executive functions like planning and problem-solving in adults with mild cognitive impairment or very early Alzheimer's disease. This confirmatory clinical trial is conducted at multiple centers and is randomized, double-blind, and parallel-group in design. Participants continue their usual cognitive medications during the study. Participants are randomly assigned to receive either the Neuclare device or a sham device as a control. Both groups continue their standard medication. The device is applied to the brain three times a week for four weeks, with each session lasting less than 30 minutes. The study staff and participants do not know which treatment is given to ensure unbiased results. Throughout the trial, participants undergo assessments including attention, cognitive function, daily living activities, brain imaging with Amyloid PET-CT, blood biomarker testing, and quality of life questionnaires. Safety and any adverse events are carefully monitored. The primary measure is the change in time to complete the Trail Making Test-A from baseline to five weeks. The study ends in July 2026.
CONDITIONS
Brief Title
Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 90 years
- Diagnosed with probable Alzheimer's disease or mild cognitive impairment 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 will not qualify if you...
- Structural brain lesions detected on MRI (e.g., edema, hemorrhage, infarction, tumor)
- Uncontrolled metabolic disorders or long-term medications causing cognitive impairment
- History of epileptic seizures, depression, psychiatric disorders, visual hallucinations, or fluctuating cognitive decline
- Severe diseases such as cancer or tuberculosis
- Use of psychoactive drugs affecting the nervous system
- Contact dermatitis or skin hypersensitivity
- Fever ≥ 40°C by tympanic measurement
- Recent bleeding within past 3 months from procedures or surgeries
- Unable to undergo MRI
- Pregnancy
- Brain calcification seen on CT
- Known allergies to contrast agents like Definity or Gadovist
- Any condition deemed inappropriate by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive the Neuclare device or a sham device applied to the cerebral cortex with low-intensity ultrasound stimulation less than 30 minutes per session, three times per week for 4 weeks while continuing their cognitive medication.
Up to 12 visits (3 visits per week for 4 weeks, in-person)
Trial Site Locations
Total: 3 locations
1
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea, 18450
Not Yet Recruiting
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
3
Ewha Womans University Mokdong Hospital
Seoul, South Korea, 07985
Actively Recruiting
Research Team
S
Sung Kyung Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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