DementiaNCT06017505
Integrating eSAGE With EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals
An observational study of Dementia and Alzheimer Disease, run by Douglas Scharre at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- electronic self administered gerocognitive examination (eSAGE)
- How many people
- 1,486 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- Dementia, Alzheimer Disease, Mild Cognitive Impairment, Worried Well
- Being tested
- electronic self administered gerocognitive examination (eSAGE)
- Medical subject headings
- Dementia, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: electronic self administered gerocognitive examination (eSAGE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Scharre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Douglas Scharre, Ohio State University
- Investigators
- Douglas Scharre, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017505
- Sponsor's protocol ID
- 2023H0249
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06017505
- Acronym / sponsor ID
- 2023H0249
- Conditions
- Dementia, Alzheimer Disease, Mild Cognitive Impairment, Worried Well
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,486 participants (estimated)
- Lead sponsor
- Douglas ScharreUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject population | – | Diagnostic Test: 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Subject population |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas Scharre principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Alzheimer Disease, run by Douglas Scharre at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.