NCT05385874

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

May 11, 2022

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • AUC

    the AUC of the prediciton model based on the test data

    an average of 3 years after baseline assessement

Secondary Outcomes (4)

  • sensitivity

    an average of 3 years after baseline assessement

  • specificity

    an average of 3 years after baseline assessement

  • positive predictive value

    an average of 3 years after baseline assessement

  • negative predictive value

    an average of 3 years after baseline assessement

Study Arms (2)

Training cohort

The training cohort will be used for model development.

Testing cohort

The testing cohort, a new cohort compared with the training cohort, will be used for model external validation.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Six Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Feifei Gao, Ph.D

    Peking University Six Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Researcher

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 23, 2022

Study Start

April 1, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations