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Completed

NCT Number: NCT02544074

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

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.

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Key information

Conditions

Mild Cognitive Impairment Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neuropsychological testing

Behavioral

standard neuropsychological testing including brief standardized assessments

eSAGE testing

Behavioral

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Primary outcomes

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

    Time frame: 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 outcomes

  1. eSAGE Score Compared to the Paper SAGE Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Brain Test, Inc.

Registry information

Acronym: eSAGE

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2015
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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