NCT07618481 · RECRUITING

BCI With 40Hz Stimulation in Alzheimer's Disease

This trial is testing whether a non-invasive brain stimulation device using 40Hz audio-visual pulses can support cognitive function in people already diagnosed with Alzheimer's disease. One group gets fixed 40Hz stimulation, one gets a personalized version adjusted by real-time brainwave feedback, and one gets a sham (inactive) device. Everyone uses it 60 minutes a day for 6 months. This is a Phase NA trial — meaning it is evaluating a device technique, not a drug, and results are not yet established.

You may qualify if

  • Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.
  • Age between 50 and 80 years, inclusive.
  • Positive Aβ-PET scan result.
  • Has a stable caregiver who can assist with daily stimulation intervention.
  • Chronic medical conditions stable for at least 30 days.
  • Adequate vision and hearing to perform testing (at minimum, ability to perceive light and communicate in daily conversation).
  • Good mobility (able to walk independently or with assistive devices).
  • Willing and able to provide voluntary signed informed consent.

You're excluded if

  • History of epilepsy or seizure disorder.
  • Inability to undergo MRI or presence of significant abnormalities on MRI screening.
  • Geriatric Depression Scale (GDS) score > 6.
  • Current suicidal ideation or suicide attempt within the past 6 months.
  • Other major neurological disorders, including but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis/encephalitis) or multiple concussions; metabolic/systemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).
  • Psychiatric disorders.
  • Severe cardiac disease, chronic liver/kidney/respiratory disease, or uncontrolled diabetes mellitus or thyroid disease.
  • History of drug or alcohol abuse within the past 12 months.
  • Current exposure to anti-Aβ antibody immunotherapies.
  • Current use of memantine within 30 days prior to intervention.
  • Life expectancy \< 24 months.

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 2026-06-01

View full record on ClinicalTrials.gov

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