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

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

This study will test whether wearing the Neuclare brain device three times a week for four weeks can temporarily improve planning and problem-solving in adults aged 55–90 with mild cognitive impairment or very early Alzheimer's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 55 Years to 90 Years
• Sex: All
• Sponsor: Deepsonbio (Industry-sponsored)
• Locations: 3 sites (Hwaseong-si, Gyeonggi-do and 2 other locations)
• Trial ID: NCT07239310 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 55–90 with mild cognitive impairment or very early Alzheimer's (CDR 0.5–1, MMSE-II ≥18) who are on stable cognitive medication for at least one month and can provide informed consent.

Not a fit: Patients with structural brain lesions on MRI, uncontrolled metabolic or hepatic/renal disorders, a history of seizures or major psychiatric illness, or those taking long-term anticholinergic medications are excluded and unlikely to receive benefit from this device.

Why it matters

Potential benefit: If successful, the Neuclare device could provide a non-drug option to temporarily boost executive skills such as planning and problem-solving, potentially helping with daily functioning.

How similar studies have performed: Previous small studies of noninvasive neuromodulation have shown mixed and often short-lived cognitive benefits, while large confirmatory trials remain limited.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 55 to 90 years.
2. Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,
3. or 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 this trial is running

Hwaseong-si, Gyeonggi-do and 2 other locations

• Hallym University Dongtan Sacred Heart Hospital — Hwaseong-si, Gyeonggi-do, South Korea (Not_yet_recruiting)
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
• Ewha Womans University Mokdong Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Sung Kyung Lee

Conditions Mild Cognitive Impairment; Alzheimer's Disease