Development and Multicenter Validation of a Personalized Transcranial Alternating Current Stimulation Protocol for Cognitive Impairment in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Moca score
研究概览
简要总结
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.
详细描述
This study is designed to improve the treatment and care of older adults with cognitive impairment through three related projects.
Project 1: Development of a personalized cognitive training program. Using advanced computer algorithms, we will match training tasks to each patient's needs across multiple cognitive domains. About 300 participants will be enrolled from hospitals and community health centers in two provinces to test the effectiveness of this program in a randomized controlled trial.
Project 2: Development of a personalized brain stimulation program. Based on brain imaging data and artificial intelligence models, we will create individualized transcranial alternating current stimulation (tACS) plans to deliver precise, safe, and effective stimulation. About 160 participants will be recruited from the same sites to evaluate safety and effectiveness in a randomized controlled trial.
Project 3: Development of a data governance and ethics framework. Building on the first two projects, we will review international literature and consult experts in ethics, geriatrics, neuroscience, and data governance to create a framework for managing multimodal data and ethical issues in cognitive impairment research.
Together, these projects aim to provide personalized, scientifically validated treatment strategies and ensure that research data are managed safely and ethically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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);
- •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.
研究组 & 干预措施
Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training
干预措施: Transcranial Alternating Current Stimulation (tACS) (Device)
Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training
干预措施: AI-based Cognitive Training (Other)
Sham intervention
干预措施: Sham intervention (Other)
结局指标
主要结局
Moca score
时间窗: 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.
次要结局
- Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).(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.)