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

March 18, 2025 updated by: Douglas Scharre

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1486

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43123
        • Nicole Vrettos

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will include 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.

Description

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

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
Intervention / Treatment
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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Douglas Scharre

Investigators

  • Principal Investigator: Douglas Scharre, Ohio State University

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)

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023H0249

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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