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Clinical Trials/NCT04924361
NCT04924361
Recruiting
Not Applicable

Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Peking Union Medical College Hospital1 site in 1 country2,000 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Peking Union Medical College Hospital
Enrollment
2000
Locations
1
Primary Endpoint
Incorporating age stratified biomarkers into the diagnosis of dementia
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Biomarkers are important for early and precise diagnosis of dementia. However, the causes of dementia in different age are different. We designed an age stratified dementia cohort and tried to 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.

Detailed Description

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. Multi-model neuroimaging evaluation: Structure and functional brain 3T-MRI; 7T-MRI; PET-CT including FDG, Aβ(18F-AV45),tau(18F-THK5317, 18F-T807); EEG Multi-omics biomarkers research: CSF AD biomarkers (Aβ40,42, ptau181, ttau, NfL, Neurogranin), comparison of different methods, including ELISA, Electrochemical, Mass Spectroscopy. The standardization of CSF biomarkers analysis in China. Exploring new fluid biomarkers: CSF and Urine proteomics; CSF and serum glycomics and metabolomics. To explore new biomarkers in differentiation of different causes of dementia, age onset and prognosis of dementia. Genetic biomarkers evaluation: including pathogenic gene mutation panel examination and WES. Data analysis and biomarkers evaluation: Dementia patients are stratified based on age onset, cause of dementia, cognition severity, effect of therapy, prognosis. Identify multi-omics biomarkers in different groups. Comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Autopsy based accurate diagnosis help further defining biomarkers. Acquiring stratified biomarkers with high sensitivity and specificity.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
November 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

gaojing

Professor, Department of Neurology

Peking Union Medical College Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incorporating age stratified biomarkers into the diagnosis of dementia

Time Frame: Through study completion,an average of 5 years

Comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Incorporate biomarkers into the accurate and early diagnosis of dementia

Secondary Outcomes

  • Establishing dementia cohort including detailed clinical information, fluid samples and brain bank(Through study completion,an average of 5 years)
  • Exploring 5-10 kinds of age stratified biomarkers, including neuropsychology, neuroimaging, fluid biomarkers and genetic biomarkers(Through study completion,an average of 5 years)

Study Sites (1)

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