Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease

Inclusion criteria

• Adults aged 55 to 90 years.
• Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,
• or 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.

Exclusion criteria

• 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.