PUMCH Dementia Longitudinal Cohort Study

Study Overview
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Brief Summary
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The PUMCH Dementia Cohort is a hospital-based, observational study of Chinese elderly with cognitive impairment.

Detailed Description
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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.

Official Title
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Peking Union Medical College Hospital (PUMCH) Dementia Longitudinal Cohort Study

Conditions
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Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Dementia Frontal, Dementia, Mild

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia Fixed care giver and can follow up regularly Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early onset dementia<br>Dementia patients with onset age lower than 65y/o | |
| Late onset dementia<br>Dementia patients with onset age between 65y/o and 85y/o | |
| Oldest old dementia<br>Dementia patients with onset age older than 85y/o | |
| Cognitive normal control<br>Normal Aging with normal cognitive function | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of dementia | Through follow up of cognitive normal control ,to find the incidence of dementia in PUMCH cohort | Through study completion,an average of 10-20 years | 
| The relationship between lifestyles, stress (stressful events and their degree) and dementia | 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 | Through study completion,an average of 10 years | 
| Risk factors for dementia | Collect the risk factors in normal control and analysis the relationship after diagnosis of dementia | Through study completion,an average of 10-20 years | 
| Cognitive decline | Use a systematic neuropsychological battery designed by PUMCH | Through study completion,an average of 10-20 years | 
| Functional decline | Use Activity of Daily Living Scale（ADL） | Through study completion,an average of 10-20 years | 
| Changes in the Neuropsychiatric Index (NPI) | 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. | Through study completion,an average of 10 years | 
| Changes in the Hospital Anxiety and Depression scale (HAD) | 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. | Through study completion,an average of 10 years | 
| Changes in the Cornell Scale for dementia | 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. | Through study completion,an average of 10 years | 
| Tau and Beta-amyloid biomarkers in CSF | Concentration ( pg/mL) of beta-amyloid, tau and phospho-tau in cerebrospinal fluid (CSF) of patients with dementia and controls | Through study completion,an average of 10 years | 
| Tau biomarkers in serum | Concentration ( pg/mL) of tau in serum of patients with dementia and controls | Through study completion,an average of 10 years | 
| CSF collection for assessing new dementia biomarker | Use collected CSF to assess new biomarkers. | Through study completion,an average of 10 years | 
| Serum collection for assessing new dementia biomarker | Use collected serum to assess new biomarkers. | Through study completion,an average of 10 years | 
| Urine collection for assessing new dementia biomarker | Use collected urine to assess new biomarkers. | Through study completion,an average of 10 years | 
| Skin collection for assessing new dementia biomarker | Use collected skin for finding new biomarkers. | Through study completion,an average of 10 years | 
| Biomarker differences of dementia | The differences of biomarkers in patients with different dementia. | Through study completion,an average of 10 years | 
| Incorporating age stratified biomarkers into the diagnosis of dementia | Comparing the relationships between biomarkers and clinical presentations. Incorporate biomarkers into the accurate and early diagnosis of dementia | Through study completion,an average of 10 years | 
| Dementia education and training | Observe the function of education and training in the treatment and care of dementia patients | Through study completion,an average of 10 years | 
| Dementia diagnosis system and evaluation system | Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia | Through study completion,an average of 10 years |