NCT07031687 · RECRUITING
Effects and Mechanisms of Temporal Interference Brain Stimulation on Memory Function in Preclinical Alzheimer's Disease
This trial is testing a non-invasive brain stimulation technique called Temporal Interference Brain Stimulation, or TIBS, in people who have early biological signs of Alzheimer's but no symptoms yet. Researchers use MRI scans and real-time brainwave monitoring to personalize the stimulation, then deliver it daily for two weeks. They want to know whether it improves memory and changes brain connectivity. This is a Phase NA trial — meaning it is exploratory research, not yet proven or approved.
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.
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 2025-08-15