Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Dementia Clinical Trial

Official title:

Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924361
• Other study ID #: PUMCH Dementia Cohort Research
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: November 2025

Study information

• Verified date: September 2022
• Source: Peking Union Medical College Hospital
• Contact: Chenhui Mao, Doctor
• Phone: +86018611895308
• Email: maochenhui[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Alzheimers
• Dementia Frontal
• Dementia With Lewy Bodies
• Dementia, Mixed
• Dementia, Vascular
• Lewy Body Disease

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018. Review. — View Citation

Kuruppu DK, Matthews BR. Young-onset dementia. Semin Neurol. 2013 Sep;33(4):365-85. doi: 10.1055/s-0033-1359320. Epub 2013 Nov 14. Review. — View Citation

Rabinovici GD. Late-onset Alzheimer Disease. Continuum (Minneap Minn). 2019 Feb;25(1):14-33. doi: 10.1212/CON.0000000000000700. Review. — View Citation

Yang Z, Slavin MJ, Sachdev PS. Dementia in the oldest old. Nat Rev Neurol. 2013 Jul;9(7):382-93. doi: 10.1038/nrneurol.2013.105. Epub 2013 Jun 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion,an average of 5 years
Secondary	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.	Through study completion,an average of 5 years
Secondary	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	Through study completion,an average of 5 years