An observational study in Mild Cognitive Impairment and Dementia, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Ohio State University · Observational
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.
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.
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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.
Exclusion Criteria:
Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.
Behavioral: neuropsychological testing
Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.
Behavioral: eSAGE testing
standard neuropsychological testing including brief standardized assessments
Neuropsychological testing including the eSAGE tablet and eSAGE smartphone
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.
Time frame: 3 Hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 hours
| Milestone | eSAGE Score of 2 | 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 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 20 | eSAGE Score of 21 | eSAGE Score of 22 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 4 | 1 | 2 | 4 | 6 | 2 | 2 | 3 | 4 | 5 | 5 | 8 | 6 | 3 | 4 | 3 | 3 |
| Completed | 1 | 0 | 1 | 1 | 4 | 0 | 2 | 4 | 6 | 1 | 2 | 3 | 4 | 5 | 5 | 8 | 6 | 3 | 4 | 3 | 3 |
| Not completed | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Tablet error | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| spearman rank correlation | eSAGE Score Compared to the Sum of Neuropsychological Measures |
|---|---|
| eSAGE Score Compared to the Sum of the Neuropsychological Measures. | 0.7292 |
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.
| spearman rank correlation | eSAGE Score Compared to the Paper SAGE Score |
|---|---|
| eSAGE Score Compared to the Paper SAGE Score | 0.8824 |
The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.
| spearman rank correlation | eSAGE Score Compared to the Mini-Mental State Exam Score |
|---|---|
| eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score | 0.6711 |
The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.
| spearman rank correlation | eSAGE Score Compared to the MoCA Score |
|---|---|
| eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score | 0.7577 |
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.
| spearman rank correlation | eSAGE Score Compared to the Boston Naming Test Score |
|---|---|
| eSAGE Score Compared to the Boston Naming Test Score | 0.3487 |
The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.
| spearman rank correlation | eSAGE Score Compared to the WCST Score |
|---|---|
| eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score | 0.4596 |
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.
| spearman rank correlation | eSAGE Score Compared to the HVLT Total Learning Score | eSAGE Score Compared to the HVLT Delayed Recall Score |
|---|---|---|
| eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score | 0.6045 | 0.4866 |
The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.
| spearman rank correlation | eSAGE Score Compared to the FAS Verbal Fluency Task Score |
|---|---|
| eSAGE Score Compare to the FAS Verbal Fluency Task Score | 0.3210 |
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.
| spearman rank correlation | eSAGE Score Compared to the WAIS III Letter-number Score |
|---|---|
| eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score | 0.5349 |
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.
| spearman rank correlation | eSAGE Score Compared to the WAIS III Block Design Score |
|---|---|
| eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score | 0.5774 |
Collected over Adverse event data was collected for 1 day, the day of the study visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| eSAGE Score of 2 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| eSAGE Score of 3 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| eSAGE Score of 4 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| eSAGE Score of 5 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| eSAGE Score of 6 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| eSAGE Score of 7 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| eSAGE Score of 8 | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| eSAGE Score of 9 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| eSAGE Score of 10 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| eSAGE Score of 11 | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| eSAGE Score of 12 | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| eSAGE Score of 13 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| eSAGE Score of 14 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| eSAGE Score of 15 | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| eSAGE Score of 16 | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| eSAGE Score of 17 | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| eSAGE Score of 18 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| eSAGE Score of 19 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| eSAGE Score of 20 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| eSAGE Score of 21 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| eSAGE Score of 22 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | eSAGE Score of 2 | 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 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 20 | eSAGE Score of 21 | eSAGE Score of 22 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 6 |
| >=65 years | 1 | 1 | 1 | 1 | 4 | 1 | 2 | 4 | 6 | 2 | 2 | 3 | 4 | 4 | 4 | 5 | 6 | 3 | 4 | 3 | 2 | 63 |
| Sex: Female, Male(Participants) | eSAGE Score of 2 | 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 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 20 | eSAGE Score of 21 | eSAGE Score of 22 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 3 | 4 | 1 | 2 | 2 | 2 | 4 | 2 | 7 | 3 | 2 | 3 | 2 | 3 | 44 |
| Male | 1 | 1 | 1 | 0 | 1 | 1 | 2 | 1 | 2 | 1 | 0 | 1 | 2 | 1 | 3 | 1 | 3 | 1 | 1 | 1 | 0 | 25 |
| Race (NIH/OMB)(Participants) | eSAGE Score of 2 | 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 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 20 | eSAGE Score of 21 | eSAGE Score of 22 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 5 |
| White | 1 | 1 | 1 | 1 | 3 | 1 | 2 | 3 | 6 | 2 | 2 | 3 | 4 | 2 | 4 | 7 | 6 | 2 | 3 | 3 | 3 | 60 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
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Ohio State University