Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study
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
- Changes in the Cornell Scale for dementia
研究概览
简要总结
The PUMCH Dementia Cohort is a hospital-based, observational study of Chinese elderly with cognitive impairment.
详细描述
In China, the burden of dementia is increasing, which has a major impact on medical care, society, and the economy. In order to solve this important public health problem, a cohort study of cognitive impairment in the elderly should be carried out. We designed an age stratified dementia cohort and tried to to clarify the risk and prognostic factors, disease characteristics, cognitive evaluation, biomarkers, diagnosis, treatment of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive dementia database, improve the level of clinical diagnosis and treatment of cognitive impairment, and formulate prevention and treatment strategies for dementia.
Baseline data collection and cohort establishing: Detailed clinical information including demographic data, clinical history, past history and physical examination are collected. Formatted neuropsychological battery is used in all patients, including screening tests (MMSE, MoCA-PUMCH, ADL, HAD) and domain specific evaluation (Memory, executive function, visual spatial, calculation, language). Samples including serum, CSF, urine, skin, saliva are stored. Every patient is followed up every 6 months. Autopsy brain tissue will be collected if patients died.
The main contents of this study are following:
- Explore the relationship between lifestyles, stress and dementia.
- Assess risk factors for dementia.
- Evaluating behavioral and psychological symptoms of dementia.
- Improve the long-term follow-up cohort stratified by age and dementia type and construct the high standard information and sample bank.
- Explore biomarkers of different groups of dementia, incorporating neuropsychology, multi-model neuroimaging, metabolics and proteomics based fluid biomarkers as well as genetic biomarkers. Autopsy after clinical follow up help to verify the biomarkers.
- Establish and promote standardized and consistent biomarker detection methods.
- Dementia education and training.
- Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia
- •Fixed care giver and can follow up regularly
排除标准
- •Not demented, including MCI
- •Systemic severe diseases and severe vision or hearing problem effecting follow up and neuropsychological evaluation
- •Without fixed care giver
- •Reject informed consent
- •Expected life shorter than 2 years
结局指标
主要结局
Changes in the Cornell Scale for dementia
时间窗: Through study completion,an average of 10 years
In dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.
Dementia education and training
时间窗: Through study completion,an average of 10 years
Observe the function of education and training in the treatment and care of dementia patients
Tau and Beta-amyloid biomarkers in CSF
时间窗: Through study completion,an average of 10 years
Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) of patients with dementia and controls
Tau biomarkers in serum
时间窗: Through study completion,an average of 10 years
Concentration ( pg/mL) of tau in serum of patients with dementia and controls
CSF collection for assessing new dementia biomarker
时间窗: Through study completion,an average of 10 years
Use collected CSF to assess new biomarkers.
Skin collection for assessing new dementia biomarker
时间窗: Through study completion,an average of 10 years
Use collected skin for finding new biomarkers.
Cognitive decline
时间窗: Through study completion,an average of 10-20 years
Use a systematic neuropsychological battery designed by PUMCH
The relationship between lifestyles, stress (stressful events and their degree) and dementia
时间窗: Through study completion,an average of 10 years
Analysis of the relationship between lifestyles, stress and progression of dementia. Discover lifestyle factors (such as diet, residential environment, physical activity, hobbies, and sleep) and stress (stressful events and their degree) by using a questionnaire designed by PUMCH
Risk factors for dementia
时间窗: Through study completion,an average of 10-20 years
Collect the risk factors in normal control and analysis the relationship after diagnosis of dementia
Functional decline
时间窗: Through study completion,an average of 10-20 years
Use Activity of Daily Living Scale（ADL）
Changes in the Neuropsychiatric Index (NPI)
时间窗: Through study completion,an average of 10 years
In dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.
Changes in the Hospital Anxiety and Depression scale (HAD)
时间窗: Through study completion,an average of 10 years
In dementia patients, analysis their behavioral and psychological symptoms and the related factor. Discover the relationship between behavioral and psychological symptoms and biomarkers for dementia.
Serum collection for assessing new dementia biomarker
时间窗: Through study completion,an average of 10 years
Use collected serum to assess new biomarkers.
Urine collection for assessing new dementia biomarker
时间窗: Through study completion,an average of 10 years
Use collected urine to assess new biomarkers.
Dementia diagnosis system and evaluation system
时间窗: Through study completion,an average of 10 years
Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia
The incidence of dementia
时间窗: Through study completion,an average of 10-20 years
Through follow up of cognitive normal control ,to find the incidence of dementia in PUMCH cohort
Biomarker differences of dementia
时间窗: Through study completion,an average of 10 years
The differences of biomarkers in patients with different dementia.
Incorporating age stratified biomarkers into the diagnosis of dementia
时间窗: Through study completion,an average of 10 years
Comparing the relationships between biomarkers and clinical presentations. Incorporate biomarkers into the accurate and early diagnosis of dementia
次要结局
未报告次要终点