Mild Cognitive ImpairmenteSAGENCT02544074
Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
An observational study of Mild Cognitive Impairment and Dementia, run by Ohio State University at 1 site in United States.
Trial summary
The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- What is being tested?
- neuropsychological testing and eSAGE testing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 13 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from a wide variety of community events including senior centers, health fairs, educational talks to lay public, independent and assisted living facilities, and free memory screens as well as from ambulatory Geriatric or Memory Disorders Clinics. The SAGE cognitive screening tool will be given to all subjects willing to take the test.Participants who complete the SAGE test and meet inclusion and exclusion criteria will be divided into groups based on their initial SAGE scores. Each group will be composed of subjects with the same score. Individuals will be randomly selected from each group and asked to further participate in a one-time clinical evaluation. Addendum: Subjects will be recruited from community events and our clinic and research center.
Who may be able to join
- Adults over 49 years old of either gender
- Vision and hearing sufficient for compliance with tests
Who cannot join
- Diagnosis by a physician of moderate or severe dementia
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in almost any setting, does not require any staff time to administer and makes it practical to rapidly screen large numbers of individuals in the community or in their home.This trial is being conducted to study the validity of SAGE in a digital format (eSAGE) for cognitive screening.
The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.
Read more
Addendum:
The eSAGE was previously validated in an earlier stage of this trial. It was initially designed for tablet use and the exact same test has recently been formatted for smartphone use.
This addendum is being conducted to study the validity of the smartphone eSAGE compared to the tablet eSAGE for cognitive screening.
Read the detailed description
Participants will be recruited based on their eSAGE scores and evaluated with neuropsychological testing and medical history to determine their status as normal, mild cognitive impairment, or dementia.
The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.
Addendum:
Subjects will be scheduled for a one time visit where they will be administered both the tablet eSAGE and the smartphone eSAGE. eSAGE tablet scores will be compared to eSAGE smartphone scores to determine if the two formats are equivalent to each other.
- Conditions
- Mild Cognitive Impairment, Dementia
- Being tested
- neuropsychological testing, eSAGE testing
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testingBehavioural
standard neuropsychological testing including brief standardized assessments
eSAGE testingBehavioural
Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
| Study group | Role | What they receive |
|---|---|---|
| eSAGE score of 10 | Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 11 | Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 12 | Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 13 | Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 14 | Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 15 | Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 16 | Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 17 | Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 18 | Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 19 | Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 20 | Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 21 | Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 22 | Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 9 | Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 8 | Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 6 | Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 7 | Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 5 | Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 4 | Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 3 | Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| eSAGE score of 2 | Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: neuropsychological testing | |
| Smartphone eSAGE score of 13 | Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 14 | Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 15 | Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 16 | Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 17 | Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 18 | Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 19 | Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 20 | Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 21 | Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing | |
| Smartphone eSAGE score of 22 | Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing. Receives: Behavioral: eSAGE testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
eSAGE Score Compared to the Sum of the Neuropsychological Measures.
Analysis will consist of comparing the subject's scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include:
- Boston Naming Test
- Wisconsin Card Sort Task (WCST)
- Hopkins Verbal Learning Test (HVLT)
- FAS verbal fluency task
- Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests
Associations will be investigated using Spearman correlations.
Measured: 3 Hours
Secondary outcomes (9)
eSAGE Score Compared to the Paper SAGE Score
The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score
The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score
The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Boston Naming Test Score
The investigators will compare the eSAGE scores to the Boston Naming Test score. The Boston Naming Test consists of 60 pictures of nouns that subjects must try to name. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score
The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score
The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations. The investigators will also compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compare to the FAS Verbal Fluency Task Score
The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score
The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. The WAIS III Letter-number test asks subjects to recall a series of numbers in increasing order and letters in alphabetical order. Associations will be investigated using Spearman correlations.
Measured: 3 hours
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score
The investigators will compare the eSAGE scores to the WAIS III Block Design scores. The WAIS III Block Design requires the replication of red and white designs using three-dimensional colored blocks. Associations will be investigated using Spearman correlations.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJan 2015
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Test, Inc.
- Responsible party
- Principal investigator, Douglas Scharre, Ohio State University
- Investigators
- Douglas Scharre, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544074
- Sponsor's protocol ID
- 2014H0039
- Acronym
- eSAGE
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2015
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Scharre DW, Chang SI, Nagaraja HN, Vrettos NE, Bornstein RA. Digitally translated Self-Administered Gerocognitive Examination (eSAGE): relationship with its validated paper version, neuropsychological evaluations, and clinical assessments. Alzheimers Res Ther. 2017 Jun 27;9(1):44. doi: 10.1186/s13195-017-0269-3.
PubMed 28655351
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
- ClinicalTrials.gov ID
- NCT02544074
- Acronym / sponsor ID
- eSAGE / 2014H0039
- Conditions
- Mild Cognitive Impairment, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Brain Test, Inc.
- Study start
- Jan 2015 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. SAGE's self-administered feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in almost any setting, does not require any staff time to administer and makes it practical to rapidly screen large numbers of individuals in the community or in their home.This trial is being conducted to study the validity of SAGE in a digital format (eSAGE) for cognitive screening.
The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.
Addendum:
The eSAGE was previously validated in an earlier stage of this trial. It was initially designed for tablet use and the exact same test has recently been formatted for smartphone use.
This addendum is being conducted to study the validity of the smartphone eSAGE compared to the tablet eSAGE for cognitive screening.
Detailed description
Participants will be recruited based on their eSAGE scores and evaluated with neuropsychological testing and medical history to determine their status as normal, mild cognitive impairment, or dementia.
The investigators will analyze the data to learn the correlations between eSAGE and gold standard neuropsychological testing designed to differentiate normal cognition from MCI and early dementia. The investigators will also find out whether the paper (SAGE) and electronic (eSAGE) versions of SAGE could be used interchangeably or not.
Addendum:
Subjects will be scheduled for a one time visit where they will be administered both the tablet eSAGE and the smartphone eSAGE. eSAGE tablet scores will be compared to eSAGE smartphone scores to determine if the two formats are equivalent to each other.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 31
| Arm | Type | Receives |
|---|---|---|
| eSAGE score of 10 | – | Behavioral: neuropsychological testingParticipants who score a 10 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 11 | – | Behavioral: neuropsychological testingParticipants who score an 11 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 12 | – | Behavioral: neuropsychological testingParticipants who score a 12 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 13 | – | Behavioral: neuropsychological testingParticipants who score a 13 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 14 | – | Behavioral: neuropsychological testingParticipants who score a 14 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 15 | – | Behavioral: neuropsychological testingParticipants who score a 15 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 16 | – | Behavioral: neuropsychological testingParticipants who score a 16 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 17 | – | Behavioral: neuropsychological testingParticipants who score a 17 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 18 | – | Behavioral: neuropsychological testingParticipants who score a 18 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 19 | – | Behavioral: neuropsychological testingParticipants who score a 19 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 20 | – | Behavioral: neuropsychological testingParticipants who score a 20 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 21 | – | Behavioral: neuropsychological testingParticipants who score a 21 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 22 | – | Behavioral: neuropsychological testingParticipants who score a 22 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 9 | – | Behavioral: neuropsychological testingParticipants who score a 9 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 8 | – | Behavioral: neuropsychological testingParticipants who score an 8 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 6 | – | Behavioral: neuropsychological testingParticipants who score a 6 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 7 | – | Behavioral: neuropsychological testingParticipants who score a 7 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 5 | – | Behavioral: neuropsychological testingParticipants who score a 5 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 4 | – | Behavioral: neuropsychological testingParticipants who score a 4 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 3 | – | Behavioral: neuropsychological testingParticipants who score a 3 on the eSAGE. Interventions include neuropsychological testing. |
| eSAGE score of 2 | – | Behavioral: neuropsychological testingParticipants who score a 2 on the eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 13 | – | Behavioral: eSAGE testingParticipants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 14 | – | Behavioral: eSAGE testingParticipants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 15 | – | Behavioral: eSAGE testingParticipants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 16 | – | Behavioral: eSAGE testingParticipants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 17 | – | Behavioral: eSAGE testingParticipants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 18 | – | Behavioral: eSAGE testingParticipants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 19 | – | Behavioral: eSAGE testingParticipants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 20 | – | Behavioral: eSAGE testingParticipants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 21 | – | Behavioral: eSAGE testingParticipants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing. |
| Smartphone eSAGE score of 22 | – | Behavioral: eSAGE testingParticipants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from a wide variety of community events including senior centers, health fairs, educational talks to lay public, independent and assisted living facilities, and free memory screens as well as from ambulatory Geriatric or Memory Disorders Clinics. The SAGE cognitive screening tool will be given to all subjects willing to take the test.Participants who complete the SAGE test and meet inclusion and exclusion criteria will be divided into groups based on their initial SAGE scores. Each group will be composed of subjects with the same score. Individuals will be randomly selected from each group and asked to further participate in a one-time clinical evaluation. Addendum: Subjects will be recruited from community events and our clinic and research center.
Key inclusion criteria (2 listed)
- Adults over 49 years old of either gender
- Vision and hearing sufficient for compliance with tests
Key exclusion criteria (2 listed)
- Diagnosis by a physician of moderate or severe dementia
- Intellectual disability
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 |
|---|---|---|
| neuropsychological testingstandard neuropsychological testing including brief standardized assessments | Behavioural | eSAGE score of 10, eSAGE score of 11, eSAGE score of 12, eSAGE score of 13, eSAGE score of 14, eSAGE score of 15, eSAGE score of 16, eSAGE score of 17, eSAGE score of 18, eSAGE score of 19, eSAGE score of 2, eSAGE score of 20, eSAGE score of 21, eSAGE score of 22, eSAGE score of 3, eSAGE score of 4, eSAGE score of 5, eSAGE score of 6, eSAGE score of 7, eSAGE score of 8, eSAGE score of 9 |
| eSAGE testingNeuropsychological testing including the eSAGE tablet and eSAGE smartphone | Behavioural | Smartphone eSAGE score of 13, Smartphone eSAGE score of 14, Smartphone eSAGE score of 15, Smartphone eSAGE score of 16, Smartphone eSAGE score of 17, Smartphone eSAGE score of 18, Smartphone eSAGE score of 19, Smartphone eSAGE score of 20, Smartphone eSAGE score of 21, Smartphone eSAGE score of 22 |
Primary outcome
eSAGE Score Compared to the Sum of the Neuropsychological Measures.
Time frame: 3 Hours
Analysis will consist of comparing the subject's scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include: * Boston Naming Test * Wisconsin Card Sort Task (WCST) * Hopkins Verbal Learning Test (HVLT) * FAS verbal fluency task * Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests Associations will be investigated using Spearman correlations.
9 secondary outcomes
eSAGE Score Compared to the Paper SAGE Score
Time frame: 3 hours
eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score
Time frame: 3 hours
eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score
Time frame: 3 hours
eSAGE Score Compared to the Boston Naming Test Score
Time frame: 3 hours
eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score
Time frame: 3 hours
eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score
Time frame: 3 hours
eSAGE Score Compare to the FAS Verbal Fluency Task Score
Time frame: 3 hours
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score
Time frame: 3 hours
eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score
Time frame: 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28655351Scharre DW, Chang SI, Nagaraja HN, Vrettos NE, Bornstein RA. Digitally translated Self-Administered Gerocognitive Examination (eSAGE): relationship with its validated paper version, neuropsychological evaluations, and clinical assessments. Alzheimers Res Ther. 2017 Jun 27;9(1):44. doi: 10.1186/s13195-017-0269-3.
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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. This study is not recruiting at the moment.
Douglas Scharre, M.D. 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 Mild Cognitive Impairment and Dementia, run by Ohio State University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
eSAGE Score Compared to the Sum of the Neuropsychological Measures. (time frame: 3 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02544074, which also lists 1 linked publication.
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 25 Mar 2025.