Viewing Study NCT04924361



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Last Modification Date: 2024-10-26 @ 2:06 PM
Study NCT ID: NCT04924361
Status: RECRUITING
Last Update Posted: 2022-09-13
First Post: 2021-05-18

Brief Title: Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort
Sponsor: Peking Union Medical College Hospital
Organization: Peking Union Medical College Hospital

Study Overview

Official Title: Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort
Status: RECRUITING
Status Verified Date: 2022-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Aβ18F-AV45tau18F-THK5317 18F-T807 EEG

Multi-omics biomarkers research

CSF AD biomarkers Aβ4042 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None