NCT03672448

Brief Summary

Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. Based on the above understanding, the study carry out the population cohort study based on accurate diagnosis and construct the high standard information and sample bank. The study will establish the standard and quality system of geriatric cognitive disorders cohort study (unified standards and norms). The study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of elderly cognitive disorders, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. The study will apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study will evaluate whether peripheral nerve degeneration can predict central nervous system degeneration based on the large cohort of elderly study. In addition, The study will make an effective supplement the sample bank construction of Shanghai Mental Health Center.

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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

5.2 years

First QC Date

January 26, 2018

Last Update Submit

January 8, 2020

Conditions

Keywords

dementiadepressioncohort studysample bankprecision diagnosisbrain imaging

Outcome Measures

Primary Outcomes (1)

  • Prevalence, incidence of neurocognitive disorder

    Prevalence, incidence of neurocognitive disorder such as AD, MCI and other types of dementia

    5 years

Secondary Outcomes (2)

  • Prevalence, incidence of mood disorder

    5 years

  • conversion rate

    5 years

Study Arms (2)

Neurocognitive disorder

Dementias

Other: Naturalistic observation

Normal Aging

Normal Aging with normal cognitive function

Other: Naturalistic observation

Interventions

Naturalistic observation

Also known as: Normal Aging
Neurocognitive disorderNormal Aging

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10,000 adult Chinese aged 60 and up who have been living Shanghai will be recruited.

You may qualify if:

  • registered residents in the community;
  • ≥ 60 years;
  • without schizophrenia or mental retardation;
  • be able to communicate and accept physical and cognitive examinations

You may not qualify if:

  • blind
  • deaf mute

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Centre

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

  • Wang T, He H, Shi Y, Su N, Zhu M, Yan F, Liu Y, Li J, Tang M, Chen W, Bao F, Wang H, Wang Y, Liu Y, Yuan Y, Zuo X, Zhang X, Cui L, Wu W, Zhang C, Lu Y, Fang Y, Xiao S. Prevalence, incidence and modifiable factors for subtypes of mild cognitive impairment: results from the Longitudinal Ageing Study in China. Gen Psychiatr. 2025 Mar 7;38(2):e101736. doi: 10.1136/gpsych-2024-101736. eCollection 2025.

Biospecimen

Retention: SAMPLES WITH DNA

DNA and mRNA

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseDementia, VascularLewy Body DiseaseDepressionAnxiety DisordersDementia

Interventions

Observational Studies as Topic

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Huafang Li, M.D., Ph.D.

    Shanghai Mental Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shifu Xiao, M.D., Ph.D.

CONTACT

Tao Wang, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

September 14, 2018

Study Start

September 1, 2018

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations