NCT06394817

Brief Summary

This is a community-based prospective cohort study in Beijing, China. The study has been initialized in 2023 and enrolled older residents. This study aims to develop disability risk assessment standards and an early warning model for older adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
450mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress8%
Feb 2023May 2063

Study Start

First participant enrolled

February 20, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
39 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2063

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2063

Last Updated

June 20, 2024

Status Verified

April 1, 2024

Enrollment Period

40.2 years

First QC Date

April 16, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

Disability, Ageing, Cohort

Outcome Measures

Primary Outcomes (8)

  • The prevalence and incidence of functional disability using a population-based survey

    Functional disability was measured by Activities of Daily Living, cognitive function (Mini-Mental State Examination) and movement disorder(Short Physical Performance Battery) collected by questionnaires.The minimum value of the Activities of Daily Living is 0, and the maximum value is 100, the higher the score, the better the outcome.The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the outcome.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome.

    An average of 1 to 2 years

  • The prevalence and incidence of mild cognitive impairment using a population-based survey

    Mild cognitive impairment was measured using Mini-Mental State Examination collected by questionnaire.The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the outcome.

    An average of 1 to 2 years

  • The prevalence and incidence of dementia using a population-based survey

    Dementia was determined by diagnosis of hospitalization or diagnosis of death or Clinical Dementia Rating scale. The minimum value of the Clinical Dementia Rating is 0, and the maximum value is 3, the higher the score, the worse the outcome.

    An average of 1 to 2 years

  • The conversion rate of normal to mild cognitive impairment

    Percentage of enrolled population that convert from normal to mild cognitive impairment

    An average of 1 to 2 years

  • The conversion rate of mild cognitive impairment to dementia

    Percentage of enrolled population that convert from mild cognitive impairment to dementia

    An average of 1 to 2 years

  • The genetic and environmental factors for mild cognitive impairment and dementia at genomic and expression levels

    Discover risk factors including genetic susceptibility loci (APOE genes and other risk genes) using gene sequencing, cardiovascular risk factors (blood glucose, cholesterol, homocysteine) using laboratory tests, and unhealthy lifestyle using questionnaire.

    An average of 1 to 2 years

  • The biomarkers for normal, mild cognitive impairment, and dementia diagnosis

    Humoral biomarkers are included Aβ42, Aβ40, phosphated tau and total tau in plasma, cerebrospinal fluid, saliva, and urine. Imaging biomarkers are included cerebral volume, glucose metabolism, amyloid and tau deposition of whole brain or hippocampus.

    An average of 1 to 2 years

  • The prevalence and incidence of movement disorder using a population-based survey

    Movement disorder was measured using Short Physical Performance Battery collected by questionnaire.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome.

    An average of 1 to 2 years

Study Arms (1)

Total

All subjects

Other: No intervention

Interventions

No intervention

Total

Eligibility Criteria

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

Community residents aged 60 years or older in China

You may qualify if:

  • Aged 60 years or older
  • Lived in the community for more than 1 year
  • Signed the informed consent form

You may not qualify if:

  • Cannot complete the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plan to obtain blood samples from some of the participants

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yi Tang, MD., PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Tang, MD., PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 16, 2024

First Posted

May 1, 2024

Study Start

February 20, 2023

Primary Completion (Estimated)

May 1, 2063

Study Completion (Estimated)

May 1, 2063

Last Updated

June 20, 2024

Record last verified: 2024-04

Locations