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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02544074

Acronym

eSAGE

Enrollment

Registered

2015-09-09

Start date

2015-01-31

Completion date

2024-11-13

Last updated

2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Mild Cognitive Impairment

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.

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.

Interventions

BEHAVIORALneuropsychological testing

standard neuropsychological testing including brief standardized assessments

BEHAVIORALeSAGE testing

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
eSAGE Score of 2 Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	1
eSAGE Score of 3 Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	1
eSAGE Score of 4 Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	1
eSAGE Score of 5 Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	1
eSAGE Score of 6 Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	4
eSAGE Score of 7 Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	1
eSAGE Score of 8 Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	2
eSAGE Score of 9 Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	4
eSAGE Score of 10 Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	6
eSAGE Score of 11 Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	2
eSAGE Score of 12 Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	2
eSAGE Score of 13 Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	3
eSAGE Score of 14 Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	4
eSAGE Score of 15 Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	5
eSAGE Score of 16 Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	5
eSAGE Score of 17 Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	8
eSAGE Score of 18 Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	6
eSAGE Score of 19 Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	3
eSAGE Score of 20 Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	4
eSAGE Score of 21 Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	3
eSAGE Score of 22 Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing. neuropsychological testing: standard neuropsychological testing including brief standardized assessments	3
Total	69

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012	FG013	FG014	FG015	FG016	FG017	FG018	FG019	FG020
Overall Study	Tablet error	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Overall Study	Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline characteristics

Characteristic	Total	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 2	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
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	63 Participants	1 Participants	1 Participants	1 Participants	4 Participants	1 Participants	2 Participants	4 Participants	6 Participants	2 Participants	2 Participants	1 Participants	3 Participants	4 Participants	4 Participants	4 Participants	5 Participants	6 Participants	3 Participants	4 Participants	3 Participants	2 Participants
Age, Categorical Between 18 and 65 years	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	5 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	60 Participants	1 Participants	1 Participants	1 Participants	3 Participants	1 Participants	2 Participants	3 Participants	6 Participants	2 Participants	2 Participants	1 Participants	3 Participants	4 Participants	2 Participants	4 Participants	7 Participants	6 Participants	2 Participants	3 Participants	3 Participants	3 Participants
Sex: Female, Male Female	44 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	3 Participants	4 Participants	1 Participants	2 Participants	0 Participants	2 Participants	2 Participants	4 Participants	2 Participants	7 Participants	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants
Sex: Female, Male Male	25 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants	1 Participants	3 Participants	1 Participants	1 Participants	1 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk	EG018 affected / at risk	EG019 affected / at risk	EG020 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 1	0 / 1	0 / 1	0 / 4	0 / 1	0 / 2	0 / 4	0 / 6	0 / 2	0 / 2	0 / 3	0 / 4	0 / 5	0 / 5	0 / 8	0 / 6	0 / 3	0 / 4	0 / 3	0 / 3
other Total, other adverse events	0 / 1	0 / 1	0 / 1	0 / 1	0 / 4	0 / 1	0 / 2	0 / 4	0 / 6	0 / 2	0 / 2	0 / 3	0 / 4	0 / 5	0 / 5	0 / 8	0 / 6	0 / 3	0 / 4	0 / 3	0 / 3
serious Total, serious adverse events	0 / 1	0 / 1	0 / 1	0 / 1	0 / 4	0 / 1	0 / 2	0 / 4	0 / 6	0 / 2	0 / 2	0 / 3	0 / 4	0 / 5	0 / 5	0 / 8	0 / 6	0 / 3	0 / 4	0 / 3	0 / 3

Outcome results

Primary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Sum of the Neuropsychological Measures.	0.7292 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Boston Naming Test Score	0.3487 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score	0.6045 spearman rank correlation
eSAGE Score Compared to the HVLT Delayed Recall Score	eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score	0.4866 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score	0.6711 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score	0.7577 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Paper SAGE Score	0.8824 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score	0.5774 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score	0.5349 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score	0.4596 spearman rank correlation

Secondary

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

Arm	Measure	Value (NUMBER)
eSAGE Score Compared to the Sum of Neuropsychological Measures	eSAGE Score Compare to the FAS Verbal Fluency Task Score	0.3210 spearman rank correlation

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

eSAGE Score Compared to the Sum of the Neuropsychological Measures.

eSAGE Score Compared to the Boston Naming Test Score

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

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

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

eSAGE Score Compared to the Paper SAGE Score

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

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

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

eSAGE Score Compare to the FAS Verbal Fluency Task Score