Neuclare device to temporarily improve planning and problem-solving in people with mild cognitive impairment or early Alzheimer's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double‑blind, sham‑controlled multicenter trial enrolls adults aged 55–90 with mild cognitive impairment or very early Alzheimer's who remain on stable cognitive medications. Participants are randomly assigned to receive either the active Neuclare device or a sham device applied to the head three times per week for four weeks, with both participants and study staff blinded to assignment. Outcome measures include tests of attention and executive function, activities of daily living, amyloid PET‑CT imaging, blood biomarkers, and quality-of-life (EQ-5D-5L), and safety and adverse events are closely monitored. The trial aims to determine whether the Neuclare device, added to standard care, produces a temporary improvement in executive function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 55 to 90 years.
2. 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.
3. mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
4. On stable cognitive therapy medications for at least 1 month.
5. Voluntary participation with signed informed consent.

Exclusion Criteria:

1. Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).
2. 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).
3. Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
4. Patients with psychiatric disorders outside of the inclusion criteria.
5. Patients with a history of severe diseases such as cancer or tuberculosis.
6. Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
7. Patients with contact dermatitis or other skin hypersensitivity conditions.
8. Patients with fever ≥ 40°C as measured by tympanic temperature.
9. Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
10. Patients unable to undergo MRI.
11. Pregnant patients.
12. Patients with clinical brain calcification observed on computed tomography (CT) scans.
13. Patients with known allergies to contrast agents such as Definity or Gadovist.
14. Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.

Where it's running

• Soonchunhyang University Cheonan Hospital
  Cheonan, Chungcheongnam-do, South Korea Recruiting
• Hallym University Dongtan Sacred Heart Hospital
  Hwaseong-si, Gyeonggi-do, South Korea Recruiting
• Inha University Hospital
  Incheon, Gyeonggi-do, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• The Catholic University of Korea, St. Vincent's Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Ewha Womans University Seoul Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Sung Kyung Lee
• Email: sklee@deepsonbio.com
• Phone: 82+10-9877-8173

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.