Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)

Conditions
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Dementia, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: neuropsychological testing
* Behavioral: eSAGE testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 49 years old of either gender Vision and hearing sufficient for compliance with tests Exclusion Criteria: Diagnosis by a physician of moderate or severe dementia Intellectual disability

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eSAGE score of 10<br>Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 11<br>Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 12<br>Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 13<br>Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 14<br>Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 15<br>Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 16<br>Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 17<br>Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 18<br>Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 19<br>Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 20<br>Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 21<br>Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 22<br>Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 9<br>Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 8<br>Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 6<br>Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 7<br>Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 5<br>Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 4<br>Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 3<br>Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| eSAGE score of 2<br>Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. | Behavioral: neuropsychological testing<br>* standard neuropsychological testing including brief standardized assessments<br>|
| Smartphone eSAGE score of 13<br>Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 14<br>Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 15<br>Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 16<br>Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 17<br>Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 18<br>Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 19<br>Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 20<br>Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 21<br>Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|
| Smartphone eSAGE score of 22<br>Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing. | Behavioral: eSAGE testing<br>* Neuropsychological testing including the eSAGE tablet and eSAGE smartphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 hours |