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

Dementia Clinical Trial

— eSAGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02544074
• Other study ID #: 2014H0039
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• neuropsychological testing
standard neuropsychological testing including brief standardized assessments
• eSAGE testing
Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Brain Test, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 Hours
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.	3 hours
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.	3 hours
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.	3 hours
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.	3 hours
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.	3 hours
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.	3 hours
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.	3 hours
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.	3 hours
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.	3 hours