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