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Clinical Trials/NCT06017505
NCT06017505
Enrolling By Invitation
Not Applicable

Integrating the Electronic Self-administered Gerocognitive Examination (eSAGE) with Electronic Health Records (EHR) Data Using Machine Learning (ML) for the Early Detection and Monitoring of Cognitive Impairment in Individuals

Douglas Scharre1 site in 1 country1,486 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Douglas Scharre
Enrollment
1486
Locations
1
Primary Endpoint
Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects.
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

The goal of this observational trial is to leverage the electronic Self-Administered Gerocognitive Examination (eSAGE), a variety of metadata (a set of data that describes and gives information about other data) collected during eSAGE testing, electronic health records (EHR) information, and advanced machine learning (ML) techniques to develop a new tool that can aid in early-stage prediction of individuals with cognitive impairments.

Detailed Description

This is a retrospective and prospective record review trial for patients who are followed at the Center for Cognitive and Memory Disorders. eSAGE assessment data (including cognitive data, behavioral data, timing data and other metadata) as well as varying amount of electronic health records (EHR) data will be collected on all eligible subjects. Machine learning techniques with feature selection will identify important EHR variables to determine what may be useful for the prediction of cognitive impairment. Based on the EHR analysis additional questions will be added to the eSAGE to make an enhanced eSAGE version (eSAGE+). The goal of the eSAGE+ is to facilitate the identification of cognition impairment, and ultimately have a translational impact on Alzheimer's disease (AD) identification and management.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Douglas Scharre
Responsible Party
Sponsor Investigator
Principal Investigator

Douglas Scharre

Professor-Clinical

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • Males and females 50 years of age and over who complete the eSAGE as part of their office visit at the Center for Cognitive and Memory Disorders.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects.

Time Frame: 1 day visit

AUC ranges in value from 0 to 1

Study Sites (1)

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