Personalized Brain Stimulation for Cognitive Impairment in Older Adults (NCT07208734) | Clinical Trial Compass
By InvitationNot Applicable
Personalized Brain Stimulation for Cognitive Impairment in Older Adults
China460 participantsStarted 2024-05-01
Plain-language summary
This study aims to develop and test new personalized treatments for older adults with cognitive impairment.
Project 1: Create a personalized cognitive training program using computer algorithms to match training tasks to individual needs. About 300 participants will join a randomized trial at hospitals and community health centers.
Project 2: Develop a personalized brain stimulation program (tACS) based on brain imaging and artificial intelligence. About 160 participants will be enrolled to test safety and effectiveness.
Project 3: Build a framework for ethical data management by reviewing international practices and consulting experts.
Together, these projects will provide evidence for safe, effective, and personalized care, while ensuring responsible use of research data.
Who can participate
Age range50 Years – 90 Years
SexALL
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Inclusion criteria
✓. Inpatients or outpatients aged 50-90 years;
✓. Patients diagnosed with amnestic mild cognitive impairment (aMCI) due to AD or mild dementia due to AD, based on the 2018 NIA-AA clinical diagnostic criteria established by the National Institute on Aging and the Alzheimer's Association;
✓. Neuropsychological assessment showing MMSE scores between 18 and 26, and a CDR score of 0.5 or 1;
✓. Able to communicate fluently in Chinese (non-illiterate);
✓. For those currently receiving cholinesterase inhibitor therapy (e.g., donepezil or rivastigmine), the treatment dose must be stable, defined as a fixed dosage administered continuously for at least six weeks, with no adjustment of the medication regimen during the study period;
✓. Provision of written informed consent.
Exclusion criteria
✕. Documented history of cerebrovascular stroke, with clear neurological deficits at onset and corresponding responsible lesions on neuroimaging;
✕. Moderate to severe white matter lesions (Fazekas score 3-6);
What they're measuring
1
Moca score
Timeframe: Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.
✕. Presence of any cause of consciousness disorder;
✕. Severe aphasia or motor disability that prevents completion of neuropsychological assessments;
✕. Current psychiatric disorders;
✕. History of alcohol dependence, drug addiction, traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus, or other neurological disorders that may cause cognitive impairment;
✕. Systemic diseases that may contribute to mild cognitive impairment (e.g., hepatic or renal insufficiency, endocrine disorders, vitamin deficiencies);
✕. Considered unsuitable for participation by the investigators.