Integrating eSAGE With EHR Data Using Machine Learning 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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Worried Well

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nicole Vrettos

Columbus, Ohio, 43123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electronic self administered gerocognitive examination (eSAGE)

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.

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

Sponsors and collaborators

Lead sponsor

Douglas Scharre

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Aug 30, 2023
Registry last updated: Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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