PUMCH Dementia Longitudinal Cohort Study

Recruiting

• Conditions: Dementia, Mixed; Dementia Frontal; Dementia; Dementia, Vascular; Dementia Alzheimers; Dementia With Lewy Bodies; Dementia, Mild

• Registration Number: NCT05023564
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

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:

1. Explore the relationship between lifestyles, stress and dementia.

2. Assess risk factors for dementia.

3. Evaluating behavioral and psychological symptoms of dementia.

4. Improve the long-term follow-up cohort stratified by age and dementia type and construct the high standard information and sample bank.

5. 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.

6. Establish and promote standardized and consistent biomarker detection methods.

7. Dementia education and training.

8. Use machine learning methods to establish computer-assisted dementia diagnosis system and evaluation system. Establish prediction models for the progression of dementia.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-07-31
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-10
• Last Update Posted: 2022-09-13
• Primary Completion: 2040-12-31
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive decline	Through study completion,an average of 10-20 years	Use a systematic neuropsychological battery designed by PUMCH
The incidence of dementia	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	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	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
Changes in the Cornell Scale for dementia	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	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	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	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	Through study completion,an average of 10 years	Use collected CSF to assess new biomarkers.
Skin collection for assessing new dementia biomarker	Through study completion,an average of 10 years	Use collected skin for finding new biomarkers.
The relationship between lifestyles, stress (stressful events and their degree) and dementia	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	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	Through study completion,an average of 10-20 years	Use Activity of Daily Living Scale（ADL）
Changes in the Neuropsychiatric Index (NPI)	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)	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	Through study completion,an average of 10 years	Use collected serum to assess new biomarkers.
Urine collection for assessing new dementia biomarker	Through study completion,an average of 10 years	Use collected urine to assess new biomarkers.
Dementia diagnosis system and evaluation system	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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China