Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANS… (NCT07230158) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II)
China160 participantsStarted 2025-11-30
Plain-language summary
The goal of this study is to explore the efficacy and safety of transcranial alternating current stimulation (tACS) in patients with amnestic mild cognitive impairment due to Alzheimer's disease (AD-aMCI) and patients with mild Alzheimer's disease dementia (AD-MD). The study will recruit 160 individuals with mild cognitive impairment with evidence of amyloid plaques in the brain through Positron Emission Tomography (PET) imaging. Participants will undergo baseline cognitive assessment, structural and functional MRI characterization, PiB-PET, and EEG measurement. The participants will be randomized to either a tACS group or a sham stimulation group. At the end of the intervention, all subjects will repeat the baseline assessments.
Who can participate
Age range50 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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;
. 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;