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

• Sponsor: Ohio State University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02544074
• Collaborator: Brain Test, Inc. (Industry)
• Enrollment: 69
• Location: 1
• Duration (Months): 95.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment; Dementia	Behavioral: neuropsychological testing; Behavioral: eSAGE testing

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

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 12, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. eSAGE Score Compared to the Sum of the Neuropsychological Measures. [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.

Secondary Outcome Measures

1. eSAGE Score Compared to the Paper SAGE Score [3 hours]

   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.

2. eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score [3 hours]

   The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.

3. eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score [3 hours]

   The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.

4. eSAGE Score Compared to the Boston Naming Test Score [3 hours]

   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.

5. eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score [3 hours]

   The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.

6. eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score [3 hours]

   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.

7. eSAGE Score Compare to the FAS Verbal Fluency Task Score [3 hours]

   The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.

8. eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score [3 hours]

   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.

9. eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score [3 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43221

Sponsors and Collaborators

• Ohio State University
• Brain Test, Inc.

Investigators

• Principal Investigator: Douglas Scharre, M.D., Ohio State University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2017

More Information

Publications

None provided.

• Responsible Party: Douglas Scharre, Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT02544074
• Other Study ID Numbers: 2014H0039
• First Posted: Sep 9, 2015
• Last Update Posted: May 26, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

Participant Flow

Pre-assignment Detail	The eSAGE test is scored from 0-22 with 22 indicating a perfect score.

Arm/Group Title	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
Arm/Group Description	Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments
Period Title: Overall Study
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

Baseline Characteristics

Arm/Group Title	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
Arm/Group Description	Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	Total of all reporting groups
Overall Participants	1	1	1	1	4	1	2	4	6	2	2	3	4	5	5	8	6	3	4	3	3	69
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	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 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	1 20%	3 37.5%	0 0%	0 0%	0 0%	0 0%	1 33.3%	6 8.7%
>=65 years	1 100%	1 100%	1 100%	1 100%	4 100%	1 100%	2 100%	4 100%	6 100%	2 100%	2 100%	3 100%	4 100%	4 80%	4 80%	5 62.5%	6 100%	3 100%	4 100%	3 100%	2 66.7%	63 91.3%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	1 100%	3 75%	0 0%	0 0%	3 75%	4 66.7%	1 50%	2 100%	2 66.7%	2 50%	4 80%	2 40%	7 87.5%	3 50%	2 66.7%	3 75%	2 66.7%	3 100%	44 63.8%
Male	1 100%	1 100%	1 100%	0 0%	1 25%	1 100%	2 100%	1 25%	2 33.3%	1 50%	0 0%	1 33.3%	2 50%	1 20%	3 60%	1 12.5%	3 50%	1 33.3%	1 25%	1 33.3%	0 0%	25 36.2%
Race (NIH/OMB) (Count of Participants)
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%	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 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	2 2.9%
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%	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%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 40%	1 20%	1 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%	5 7.2%
White	1 100%	1 100%	1 100%	1 100%	3 75%	1 100%	2 100%	3 75%	6 100%	2 100%	2 100%	3 100%	4 100%	2 40%	4 80%	7 87.5%	6 100%	2 66.7%	3 75%	3 100%	3 100%	60 87%
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%	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 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	2 2.9%

Outcome Measures

1. Primary Outcome

Title	eSAGE Score Compared to the Sum of the Neuropsychological Measures.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the Sum of Neuropsychological Measures
Arm/Group Description	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.
Measure Participants	66
Number [spearman rank correlation]	0.7292

2. Secondary Outcome

Title	eSAGE Score Compared to the Paper SAGE Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the Paper SAGE Score
Arm/Group Description	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.
Measure Participants	66
Number [spearman rank correlation]	0.8824

3. Secondary Outcome

Title	eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the Mini-Mental State Exam Score
Arm/Group Description	The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.6711

4. Secondary Outcome

Title	eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the MoCA Score
Arm/Group Description	The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.7577

5. Secondary Outcome

Title	eSAGE Score Compared to the Boston Naming Test Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the Boston Naming Test Score
Arm/Group Description	The investigators will compare the eSAGE scores to the Boston Naming Test scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.3487

6. Secondary Outcome

Title	eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the WCST Score
Arm/Group Description	The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.4596

7. Secondary Outcome

Title	eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the HVLT Total Learning Score	eSAGE Score Compared to the HVLT Delayed Recall Score
Arm/Group Description	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 compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.
Measure Participants	66	66
Number [spearman rank correlation]	0.6045	0.4866

8. Secondary Outcome

Title	eSAGE Score Compare to the FAS Verbal Fluency Task Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the FAS Verbal Fluency Task Score
Arm/Group Description	The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.3210

9. Secondary Outcome

Title	eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the WAIS III Letter-number Score
Arm/Group Description	The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.5349

10. Secondary Outcome

Title	eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSAGE Score Compared to the WAIS III Block Design Score
Arm/Group Description	The investigators will compare the eSAGE scores to the WAIS III Block Design scores. Associations will be investigated using Spearman correlations.
Measure Participants	66
Number [spearman rank correlation]	0.5774

Adverse Events

Time Frame	Adverse event data was collected for 1 day, the day of the study visit.
Arm/Group Title	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
Arm/Group Description	Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments		Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments
All Cause Mortality
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/2 (0%)		0/4 (0%)		0/6 (0%)		0/2 (0%)		0/2 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/5 (0%)		0/8 (0%)		0/6 (0%)		0/3 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)
Serious Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/2 (0%)		0/4 (0%)		0/6 (0%)		0/2 (0%)		0/2 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/5 (0%)		0/8 (0%)		0/6 (0%)		0/3 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)		0/1 (0%)		0/1 (0%)		0/4 (0%)		0/1 (0%)		0/2 (0%)		0/4 (0%)		0/6 (0%)		0/2 (0%)		0/2 (0%)		0/3 (0%)		0/4 (0%)		0/5 (0%)		0/5 (0%)		0/8 (0%)		0/6 (0%)		0/3 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)

Limitations/Caveats

The majority of the subjects were Caucasian and highly educated. Results may be limited based on where the patients were recruited and their range of cognitive abilities. The ADCS-ADL scale was used as self-report in subjects without a study partner.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.