NCT07239310Recruiting
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 20 Nov 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Deepsonbio
- Diseases
- Alzheimer disease
- NCT number
- NCT07239310
What you commit to
- Study type: Interventional
- Planned participants: 138
- From 20 Nov 2025 to the primary completion date, Dec 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
Other illness
- 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 psychiatric disorders outside of the inclusion criteria.
- Patients with a history of severe diseases such as cancer or tuberculosis.
- Patients with contact dermatitis or other skin hypersensitivity conditions.
- Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
- 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.
Other
- Patients with fever ≥ 40°C as measured by tympanic temperature.
- Patients unable to undergo MRI.
- Pregnant patients.
- Patients with clinical brain calcification observed on computed tomography (CT) scans.
Who the study is looking for
- Adults aged 55 to 90 years.
- 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.
- 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.
Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soonchunhyang University Cheonan Hospital Coordinator of this site? Confirm its status | Cheonan | South Korea | Recruiting |
| Hallym University Dongtan Sacred Heart Hospital Coordinator of this site? Confirm its status | Hwaseong-si | South Korea | Recruiting |
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Ewha Womans University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.