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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06394817
Other study ID # 2022234
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2023
Est. completion date May 2063

Study information

Verified date April 2024
Source Xuanwu Hospital, Beijing
Contact Yi Tang, MD., PhD
Phone 00861083199456
Email tangyi@xwhosp.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This is a community-based prospective cohort study. Individuals who aged 60 years or older, lived in the communities for more than 1 year, and signed the informed consent form were enrolled in the present study. The study has been initialized in 2023 and aimed to develop an early warning model and a series of disability risk assessment methods for older adults. This work consists of three steps as following. First, we will build a community-based cohort and thus set up a database. Second, an intelligence model for disability risk assessment will be developed using the database. Third, a series of procedures will be established according to the risk assessment model.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date May 2063
Est. primary completion date May 2063
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Aged 60 years or older - Lived in the community for more than 1 year - Signed the informed consent form Exclusion Criteria: - Cannot complete the survey

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China Xuanwu Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary The biomarkers for normal, mild cognitive impairment, and dementia diagnosis Humoral biomarkers are included Aß42, Aß40, 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
Primary 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
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