NCT07239310 · RECRUITING
Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
This trial tests whether a brain-applied device called Neuclare can temporarily improve executive function, meaning planning and problem-solving, in people with mild cognitive impairment or very early Alzheimer's. Some people get the real device and others get a sham version, three times a week for four weeks. It is not a phase-rated drug study, so it is a device test, not yet proven.
You may qualify if
- 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.
You're excluded if
- 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 a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
- Patients with contact dermatitis or other skin hypersensitivity conditions.
- Patients with fever ≥ 40°C as measured by tympanic temperature.
- Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
- Patients unable to undergo MRI.
- Pregnant patients.
- Patients with clinical brain calcification observed on computed tomography (CT) scans.
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-07