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Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04924361
Enrollment
2000
Registered
2021-06-14
Start date
2020-12-01
Completion date
2025-11-30
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Biomarkers, Diagnosis

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incorporating age stratified biomarkers into the diagnosis of dementiaThrough study completion,an average of 5 yearsComparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Incorporate biomarkers into the accurate and early diagnosis of dementia

Secondary

MeasureTime frameDescription
Establishing dementia cohort including detailed clinical information, fluid samples and brain bankThrough study completion,an average of 5 yearsDetailed 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.
Exploring 5-10 kinds of age stratified biomarkers, including neuropsychology, neuroimaging, fluid biomarkers and genetic biomarkersThrough study completion,an average of 5 yearsFind out age stratified biomarkers with high sensitivity and specificity, including neuropsychology, Multi-model neuroimaging, Multi-omics fluid biomarkers and genetic biomarkers

Countries

China

Contacts

Primary ContactChenhui Mao, Doctor
maochenhui@pumch.cn+86018611895308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026