Personalized temporal interference brain stimulation to improve memory in preclinical Alzheimer's

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

Researchers will deliver personalized, EEG-based closed-loop temporal interference brain stimulation (TIBS) or a sham procedure over a two-week intervention guided by multimodal imaging. Participants are biomarker-defined preclinical AD (positive plasma p-tau217 or positive Aβ PET), right-handed, and will undergo baseline, end-of-intervention, and 4- and 12-week follow-up assessments. Outcomes include hippocampal–cortical functional connectivity measured by fMRI, EEG power spectra, and tests of episodic and working memory, plus safety monitoring. The trial compares active TIBS against sham to determine short- and medium-term effects on cognition and brain network activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals recruited from neurology memory clinics or communities.
* Age between 60 and 80 years old, inclusive; no gender limitation.
* Right-handed.
* Cognitive function test results within normal range after age, gender, and education-level adjustment, OR mild cognitive impairment not yet meeting diagnostic criteria for Mild Cognitive Impairment (MCI), OR only subjective cognitive decline.
* Individuals classified as preclinical AD based on the revised 2024 AD diagnostic and staging criteria (i.e., cognitively normal with positive plasma p-tau217 or positive Aβ PET).
* Full understanding of the study, voluntary participation, and provision of written informed consent approved by the Ethics Committee.

Exclusion Criteria:

* Past or present neurological diseases (e.g., stroke, epilepsy, Parkinson's disease, multiple sclerosis).
* Psychiatric disorders such as severe depression or severe anxiety.
* Systemic diseases causing cognitive decline (e.g., severe thyroid dysfunction, severe liver or kidney disease, severe nutritional deficiencies).
* Currently taking medications that may affect cognitive function (e.g., anticholinergics, benzodiazepines, antipsychotics) that cannot be discontinued or adjusted.
* Other factors leading to cognitive decline that are not AD-related.
* Contraindications for MRI scans, such as claustrophobia, implanted metallic devices (e.g., pacemakers, cochlear implants, aneurysm clips), or history of head injury with retained metal fragments.

Where it's running

• Hainan university
  Sanya, Hainan, China Recruiting
• Xuanwu Hospital of Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Ying Han, PhD — Xuanwu Hospital of Capital Medical University
• Study coordinator: Ying Han, PhD
• Email: hanying@xwh.ccmu.edu.cn
• Phone: +86 13621011941

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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.