NCT07230158 · NOT YET RECRUITING
Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II)
This trial is testing whether transcranial alternating current stimulation (tACS) — a non-invasive device that delivers mild electrical pulses to the scalp — can help cognition in people with early Alzheimer's or amyloid-confirmed mild cognitive impairment. Half the participants receive real tACS; half receive a sham (inactive) version. It is a Phase NA trial focused on efficacy and safety, meaning the approach is still being evaluated and is not proven or approved.
You may qualify if
- Patients aged 50-90 years, either inpatients or outpatients;
- Meeting the NIA-AA clinical diagnostic criteria established by the 2018 National Institute on Aging and Alzheimer's Association (NIA-AA) group for AD-related amnestic mild cognitive impairment (a-MCI) or AD-related mild dementia;
- Neuropsychological evaluation with MMSE score of 18-26 and CDR score of 0.5 or 1;
- Positive amyloid PET, or decreased amyloid levels in cerebrospinal fluid, or elevated serum phosphorylated Tau217 protein;
- Able to communicate proficiently in Chinese (non-illiterate);
- If currently receiving cholinesterase inhibitor treatment (such as donepezil or rivastigmine), the current treatment dose must be stable (i.e., fixed dose for at least 6 consecutive weeks), with no planned dose adjustments during the study observation period;
- Signed informed consent form.
You're excluded if
- Sudden onset;
- Early focal neurological manifestations or extrapyramidal manifestations;
- Systemic diseases that may cause cognitive impairment (such as liver or kidney insufficiency, endocrine diseases, or vitamin deficiency), or neurological diseases such as brain trauma, epilepsy, encephalitis, or normal pressure hydrocephalus;
- Meeting DSM-IV criteria for depression or schizophrenia;
- Ongoing drug treatments that may affect baseline or follow-up assessments;
- Contraindications for MRI or neurophysiological examinations, such as cardiac pacemakers, cardiac defibrillators, implanted electronic systems, vascular clips, mechanical heart valves, or cochlear implants;
- Cranial MRI showing ischemic lesions meeting NINCDS-AIREN criteria.
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 2025-11-17