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

• Conditions: Dementia; Alzheimer Disease; Worried Well; Mild Cognitive Impairment
• Interventions: Diagnostic Test: electronic self administered gerocognitive examination (eSAGE)

• Registration Number: NCT06017505
• Lead Sponsor: Douglas Scharre

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.

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Study Start: 2024-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1486

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject population	electronic self administered gerocognitive examination (eSAGE)	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects.	1 day visit	AUC ranges in value from 0 to 1

Trial Locations

Locations (1)

Nicole Vrettos; 🇺🇸 Columbus, Ohio, United States