- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05385874
Risk Prediction and Its Intelligent Assessment for Cognitive Impairment Among Community-dwelling Older Adults
April 2, 2024 updated by: Xiaozhen LV, Peking University Sixth Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
13228
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100191
- Peking University Six Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population of this project was those community-dwelling older adults with normal cognitive function at baseline and completed cognitive function assessment three years later.
Description
Inclusion Criteria:
- Aged 65 or over at baseline;
- With normal cognitive function at baseline (score ≥ 18 on the Chinese version of Mini-Mental State Examination, MMSE);
- Completed MMSE assessment three years later;
- Provided informed consent voluntarily.
Exclusion Criteria:
- Aged <65;
- had a history of dementia or MMSE score < 18 at baseline;
- lost to follow-up or without cognitive function assessment three years later;
- Refused to participate the survey.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Training cohort
The training cohort will be used for model development.
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Testing cohort
The testing cohort, a new cohort compared with the training cohort, will be used for model external validation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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AUC
Time Frame: an average of 3 years after baseline assessement
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the AUC of the prediciton model based on the test data
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an average of 3 years after baseline assessement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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sensitivity
Time Frame: an average of 3 years after baseline assessement
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the sensitivity of the prediciton model based on the test data
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an average of 3 years after baseline assessement
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specificity
Time Frame: an average of 3 years after baseline assessement
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the specificity of the prediciton model based on the test data
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an average of 3 years after baseline assessement
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positive predictive value
Time Frame: an average of 3 years after baseline assessement
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the positive predictive value of the prediciton model based on the test data
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an average of 3 years after baseline assessement
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negative predictive value
Time Frame: an average of 3 years after baseline assessement
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the negative predictive value of the prediciton model based on the test data
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an average of 3 years after baseline assessement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Feifei Gao, Ph.D, Peking University Six Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
May 17, 2022
First Posted (Actual)
May 23, 2022
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHOUFA2020-3-4114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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