BCI with 40Hz Stimulation for Alzheimer’s Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, sham-controlled trial enrolling 90 participants with amyloid-positive Alzheimer’s disease to compare 40Hz fixed stimulation, closed-loop BCI-stimulated EEG-tuned stimulation, and sham stimulation over six months. Participants receive 60 minutes of daily stimulation and are evaluated for cognitive changes using MoCA-B and other tests, along with multimodal brain imaging and EEG measures. The trial aims to determine safety and whether the BCI approaches can drive cognitive improvements beyond placebo. Eligibility requires a confirmed AD diagnosis, amyloid positivity, age 50–80, stable medical status, and a reliable caregiver to assist with the intervention. All procedures are conducted at Ruijin Hospital in Shanghai, with a lead sponsor and no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. History of epilepsy or seizure disorder.
2. Inability to undergo MRI or presence of significant abnormalities on MRI screening.
3. Geriatric Depression Scale (GDS) score \> 6.
4. Current suicidal ideation or suicide attempt within the past 6 months.
5. 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.).
6. Psychiatric disorders.
7. Severe cardiac disease, chronic liver/kidney/respiratory disease, or uncontrolled diabetes mellitus or thyroid disease.
8. History of drug or alcohol abuse within the past 12 months.
9. Current exposure to anti-Aβ antibody immunotherapies.
10. Current use of memantine within 30 days prior to intervention.
11. Life expectancy \< 24 months.

Where it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chao Gao
• Email: anshangaochao@163.com
• Phone: +8618217590273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.