CClinicalTrials.gg
Enrolling by invitationNCT06017505Updated Jun 15, 2026

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

An observational study in Dementia, Alzheimer Disease and Mild Cognitive Impairment, sponsored by Douglas Scharre. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Douglas Scharre · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
1,486
Ages
50 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Dementia
  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Worried Well
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In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 1,486 is above the median of 250 across 482 observational studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Douglas Scharre is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
1,486 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • Diagnostic testelectronic 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.

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What researchers measure

Primary outcomes

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

    AUC ranges in value from 0 to 1

    Time frame: 1 day visit

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Study locations

1 site
  • Nicole Vrettos
    Columbus, Ohio 43123, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06017505
Lead sponsor
Douglas Scharre
Responsible party
Douglas Scharre (Professor-Clinical, Ohio State University) — Sponsor-investigator
First posted
Aug 30, 2023
Start date
Sep 1, 2024
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Douglas Scharre
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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