NCT04924361

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

4.9 years

First QC Date

May 18, 2021

Last Update Submit

September 10, 2022

Conditions

Keywords

BiomarkersDiagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Establishing dementia cohort including detailed clinical information, fluid samples and brain bank

    Through study completion,an average of 5 years

  • Exploring 5-10 kinds of age stratified biomarkers, including neuropsychology, neuroimaging, fluid biomarkers and genetic biomarkers

    Through study completion,an average of 5 years

Study Arms (4)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia
  • Fixed care giver and can follow up regularly

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24234358BACKGROUND
  • Rabinovici GD. Late-onset Alzheimer Disease. Continuum (Minneap Minn). 2019 Feb;25(1):14-33. doi: 10.1212/CON.0000000000000700.

    PMID: 30707185BACKGROUND
  • 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.

    PMID: 23732531BACKGROUND
  • 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.

    PMID: 29653606BACKGROUND

MeSH Terms

Conditions

DementiaDementia, VascularMixed DementiasAlzheimer DiseaseLewy Body DiseaseDisease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jing Gao, Doctor

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhui Mao, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Neurology

Study Record Dates

First Submitted

May 18, 2021

First Posted

June 14, 2021

Study Start

December 1, 2020

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations