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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05385874
Other study ID # SHOUFA2020-3-4114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 30, 2023

Study information

Verified date April 2024
Source Peking University Sixth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cognitive impairment is one of the core early signs of dementia, and it is also a key stage for community-based dementia prevention. Accurate and convenient prediction of cognitive impairment can help the community to identify and manage the high-risk population of dementia. Previous studies had developed several dementia predicting models, but such models may be not suitable for cognitive impairment prediction. Based on the national representative follow-up data of Chinese Longitudinal Healthy Longevity Survey (CLHLS), this project aims to develop and validate a brief cognitive impairment prediction algorithm among the community-dwelling elderly, using machine learning methods (such as Logistic regression, Naïve Bayes model, Extreme Gradient Boosting Tree and so on). Finally, based on the constructed model, an easy-to-use online intelligent assessment tool for predicting cognitive impairment risk will be developed. The general practitioners, social workers and the elderly would be invited to use the tool and we will revise the tool according to their suggestions and comments. This project is expected to provide scientific basis and technical support for community-based dementia prevention, and will also be useful for the elderly to easily understand their cognitive health.


Recruitment information / eligibility

Status Completed
Enrollment 13228
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Aged 65 or over at baseline; 2. With normal cognitive function at baseline (score = 18 on the Chinese version of Mini-Mental State Examination, MMSE); 3. Completed MMSE assessment three years later; 4. Provided informed consent voluntarily. Exclusion Criteria: 1. Aged <65; 2. had a history of dementia or MMSE score < 18 at baseline; 3. lost to follow-up or without cognitive function assessment three years later; 4. Refused to participate the survey.

Study Design


Locations

Country Name City State
China Peking University Six Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC the AUC of the prediciton model based on the test data an average of 3 years after baseline assessement
Secondary sensitivity the sensitivity of the prediciton model based on the test data an average of 3 years after baseline assessement
Secondary specificity the specificity of the prediciton model based on the test data an average of 3 years after baseline assessement
Secondary positive predictive value the positive predictive value of the prediciton model based on the test data an average of 3 years after baseline assessement
Secondary negative predictive value the negative predictive value of the prediciton model based on the test data an average of 3 years after baseline assessement
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