Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04924361
Collaborator
(none)
2,000
1
59
33.9

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Early onset dementia

Dementia patients with onset age lower than 65y/o

Late onset dementia

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

Oldest old dementia

Dementia patients with onset age older than 85y/o

Cognitive normal control

cognitive normal control

Outcome Measures

Primary Outcome Measures

  1. Incorporating age stratified biomarkers into the diagnosis of dementia [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 Outcome Measures

  1. Establishing dementia cohort including detailed clinical information, fluid samples and brain bank [Through study completion,an average of 5 years]

    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.

  2. Exploring 5-10 kinds of age stratified biomarkers, including neuropsychology, neuroimaging, fluid biomarkers and genetic biomarkers [Through study completion,an average of 5 years]

    Find out age stratified biomarkers with high sensitivity and specificity, including neuropsychology, Multi-model neuroimaging, Multi-omics fluid biomarkers and genetic biomarkers

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Jing Gao, Doctor, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
gaojing, Professor, Department of Neurology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04924361
Other Study ID Numbers:
  • PUMCH Dementia Cohort Research
First Posted:
Jun 14, 2021
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by gaojing, Professor, Department of Neurology, Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2021