An observational study in Dementia, Dementia, Vascular and Dementia Frontal, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Peking Union Medical College Hospital · Observational
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 250 across 482 observational studies indexed under Dementia.
Browse Dementia studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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We included age stratified dementia (early onset, late onset, oldest old) , including AD, FTD,VaD, DLB and mixed dementia. Also we include cognitive normal controls.
Exclusion Criteria:
Dementia patients with onset age lower than 65y/o
Dementia patients with onset age between 65y/o and 85y/o
Dementia patients with onset age older than 85y/o
cognitive normal control
Incorporating age stratified biomarkers into the diagnosis of dementia
Comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Incorporate biomarkers into the accurate and early diagnosis of dementia
Time frame: Through study completion,an average of 5 years
Establishing dementia cohort including detailed clinical information, fluid samples and brain bank
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 after informed consent.
Time frame: Through study completion,an average of 5 years
Exploring 5-10 kinds of age stratified biomarkers, including neuropsychology, neuroimaging, fluid biomarkers and genetic biomarkers
Find out age stratified biomarkers with high sensitivity and specificity, including neuropsychology, Multi-model neuroimaging, Multi-omics fluid biomarkers and genetic biomarkers
Time frame: Through study completion,an average of 5 years
Plan to share: No
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Peking Union Medical College Hospital