Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Douglas Scharre
- Study ID
- NCT06017505
- Status
- Enrolling By Invitation
Conditions
- Alzheimer Disease
- Dementia
- Mild Cognitive Impairment
- Worried Well
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- electronic self administered gerocognitive examination (eSAGE) — DIAGNOSTIC_TESTA 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.
Study Details
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.
Key Dates
- Start date
- Sep 1, 2024
- Status verified
- Mar 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 1,486 participants (estimated)
Arms
- Arm: Subject populationMales 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 Measure
Area Under the Curve (AUC) for the ROC analysis in predicting subjects with cognitive impairment from cognitively normal subjects. [ Time Frame: 1 day visit ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nicole Vrettos | Columbus | Ohio | 43123 | - |
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