Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early onset dementia

Dementia patients with onset age lower than 65y/o

No interventions assigned to this group

Late onset dementia

Dementia patients with onset age between 65y/o and 85y/o

No interventions assigned to this group

Oldest old dementia

Dementia patients with onset age older than 85y/o

No interventions assigned to this group

Cognitive normal control

cognitive normal control

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes