A Longitudinal Study on the Aging of Health and Cognitive Impairment in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Change in Alzheimer disease biomarkers over time
研究概览
简要总结
Background: By the end of 2022, China had about 280 million people aged 60 and older, making up 19.8% of the population. This number is projected to exceed 300 million by the end of the 14th Five-Year Plan and 400 million by 2035, which would be over 30%. The 20th National Congress emphasized the need for a proactive strategy to tackle aging challenges. Approximately 6.04% of the elderly have dementia, with 3.94% having Alzheimer's disease. This totals around 15 million people with dementia. To address this, the China Cohort Consortium on Aging and Cognitive Impairment Development has been proposed to study health and cognitive changes in different age groups, aiming to support healthy aging policies. Methods: Participants from various age groups (children, youth, middle-aged, elderly) will be recruited from hospitals, schools, and communities using stratified sampling. They will undergo detailed medical examinations focusing on aging, cognitive impairments, and related diseases. A new database will track healthy aging and cognitive impairment development. Content: The study will involve comprehensive medical examinations, including physiological assessments, psychological evaluations, cognitive screenings, daily life assessments, imaging studies, and blood tests, to establish a detailed health and cognitive impairment database. The research will also investigate integrated intervention models in hospital, community, and home settings, develop remote medical management systems, and devise biomarker test kits for aging and cognitive impairments. Furthermore, it will concentrate on non-pharmacological interventions and artificial intelligence systems for the early detection, prevention, and treatment of aging-related conditions. Objectives: The China Cohort Consortium on Aging and Cognitive Impairment Development, commencing with the HAPCAD study, aims to monitor changes across various age groups, evaluate the impact of aging on health and cognitive function, and design targeted interventions. The objective is to enhance health management and services related to aging, establish effective strategies, develop therapeutic drugs, and promote healthy aging.
详细描述
Research Objectives:
Establish detailed medical examinations for population cohorts across different age groups, including physiological checks, psychological assessments, cognitive function screenings, evaluations of daily life abilities, imaging, and blood tests, to build a comprehensive health and mental impairments database. Develop artificial intelligence systems for early warnings related to aging-related diseases and create prevention and treatment strategies. Focus on advancing health management, interventions, research, and services related to healthy aging and aging-related diseases, and develop effective intervention strategies and therapeutic drugs to promote healthy aging.
Research Content:
- Screening and Tracking: Implement a long-term cohort study on healthy aging and cognitive impairment to understand changes in physiological, psychological, mental, and daily life abilities across different age groups. Analyze the effects of genetic, environmental, and lifestyle factors on healthy aging and cognitive impairments. Based on identified risk factors, develop personalized lifestyle interventions and management plans. The study will include 20,000 participants.
- Omics Approaches: Use genomics, transcriptomics, proteomics, and metabolomics to identify biomarkers associated with healthy aging, cognitive impairments, and other aging-related diseases. This will support further primary research in these areas.
Research Methods and Technical Roadmap:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to sign an informed consent form: Participants and/or their legally authorized representatives, in case of diminished decision-making capacity, are capable of reading, understanding, and providing written informed consent as per national legal requirements.
- •Capability to complete assessments independently or with assistance.
- •Willingness and ability to fulfill all study requirements, including peripheral organ function assessments, EEG, lumbar puncture, MRI, and PET imaging examinations.
- •Agreement to participate in follow-up visits.
排除标准
- •Terminal stage of significant diseases such as malignant tumors or autoimmune diseases at enrollment;
- •Substance abusers.
结局指标
主要结局
Change in Alzheimer disease biomarkers over time
时间窗: through study completion, an average of 3 year.
Aβ, t-tau and p-tau levels in pg/ml
Assessing the prevalence of cognitive impairment in China based on MMSE, MoCA and CDR.
时间窗: through study completion, an average of 5 year.
The statement involves evaluating the prevalence of cognitive impairment in China using three assessment tools: the Mini-Mental State Examination (MMSE), the Montreal Cognitive Assessment (MoCA), and the Clinical Dementia Rating (CDR). MMSE: This test has a maximum score of 30 points, with scores below 24 typically indicating cognitive impairment. MoCA: The MoCA also has a maximum score of 30 points, where a score of 26 or lower indicates cognitive impairment. CDR: The CDR uses a scale from 0 to 3, where 0 indicates no cognitive impairment, 0.5 suggests mild cognitive impairment, 1 denotes mild dementia, 2 indicates moderate dementia, and 3 reflects severe dementia.
次要结局
- Changes of brain structure at different stage of cognitive impairment in Alzheimer disease in China.(through study completion, an average of 5 year.)
- Changes of brain glucose metabolism at different stage of cognitive impairment in Alzheimer disease in China.(through study completion, an average of 3 year.)
- Changes of brain amyloid deposition at different stage of cognitive impairment in Alzheimer disease in China.(through study completion, an average of 3 year.)
- Changes of brain tau deposition at different stage of cognitive impairment in Alzheimer disease in China.(through study completion, an average of 3 year.)