Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals

NCT ID: NCT06017505

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1486 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-09-30

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.

Conditions

Dementia; Alzheimer Disease; Mild Cognitive Impairment; Worried Well

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Subject population

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.

electronic self administered gerocognitive examination (eSAGE)

Intervention Type: DIAGNOSTIC_TEST

A self-administered digital assessment that evaluates multiple cognitive domains: orientation, language, memory, executive function, calculations, abstraction, and visuospatial abilities, through multiple questions. Additionally, it includes the collection of six clinical variables: education, gender, race, family history of dementia, stroke, and emotion.

Interventions

electronic self administered gerocognitive examination (eSAGE)

A self-administered digital assessment that evaluates multiple cognitive domains: orientation, language, memory, executive function, calculations, abstraction, and visuospatial abilities, through multiple questions. Additionally, it includes the collection of six clinical variables: education, gender, race, family history of dementia, stroke, and emotion.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 1. 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

• None

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Douglas Scharre

OTHER

Sponsor Role: lead

Responsible Party

Douglas Scharre

Professor-Clinical

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Douglas Scharre

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Nicole Vrettos

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2023H0249

Identifier Type: -

Identifier Source: org_study_id