NCT02544074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 6, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

9.9 years

First QC Date

March 18, 2015

Results QC Date

June 7, 2017

Last Update Submit

March 17, 2025

Conditions

Mild Cognitive ImpairmentDementia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • eSAGE Score Compared to the Paper SAGE Score

    3 hours

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

    3 hours

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

    3 hours

  • eSAGE Score Compared to the Boston Naming Test Score

    3 hours

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

    3 hours

  • +4 more secondary outcomes

Study Arms (31)

eSAGE score of 10

Participants who score a 10 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 11

Participants who score an 11 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 12

Participants who score a 12 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 13

Participants who score a 13 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 14

Participants who score a 14 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 15

Participants who score a 15 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 16

Participants who score a 16 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 17

Participants who score a 17 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 18

Participants who score a 18 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 19

Participants who score a 19 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 20

Participants who score a 20 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 21

Participants who score a 21 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 22

Participants who score a 22 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 9

Participants who score a 9 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 8

Participants who score an 8 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 6

Participants who score a 6 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 7

Participants who score a 7 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 5

Participants who score a 5 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 4

Participants who score a 4 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 3

Participants who score a 3 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

eSAGE score of 2

Participants who score a 2 on the eSAGE. Interventions include neuropsychological testing.

Behavioral: neuropsychological testing

Smartphone eSAGE score of 13

Participants who score a 13 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 14

Participants who score a 14 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 15

Participants who score a 15 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 16

Participants who score a 16 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 17

Participants who score a 17 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 18

Participants who score a 18 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 19

Participants who score a 19 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 20

Participants who score a 20 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 21

Participants who score a 21 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Smartphone eSAGE score of 22

Participants who score a 22 on the smartphone eSAGE. Interventions include neuropsychological testing.

Behavioral: eSAGE testing

Interventions

neuropsychological testingBEHAVIORAL

standard neuropsychological testing including brief standardized assessments

eSAGE score of 10eSAGE score of 11eSAGE score of 12eSAGE score of 13eSAGE score of 14eSAGE score of 15eSAGE score of 16eSAGE score of 17eSAGE score of 18eSAGE score of 19eSAGE score of 2eSAGE score of 20eSAGE score of 21eSAGE score of 22eSAGE score of 3eSAGE score of 4eSAGE score of 5eSAGE score of 6eSAGE score of 7eSAGE score of 8eSAGE score of 9
eSAGE testingBEHAVIORAL

Neuropsychological testing including the eSAGE tablet and eSAGE smartphone

Smartphone eSAGE score of 13Smartphone eSAGE score of 14Smartphone eSAGE score of 15Smartphone eSAGE score of 16Smartphone eSAGE score of 17Smartphone eSAGE score of 18Smartphone eSAGE score of 19Smartphone eSAGE score of 20Smartphone eSAGE score of 21Smartphone eSAGE score of 22

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be recruited from a wide variety of community events including senior centers, health fairs, educational talks to lay public, independent and assisted living facilities, and free memory screens as well as from ambulatory Geriatric or Memory Disorders Clinics. The SAGE cognitive screening tool will be given to all subjects willing to take the test.Participants who complete the SAGE test and meet inclusion and exclusion criteria will be divided into groups based on their initial SAGE scores. Each group will be composed of subjects with the same score. Individuals will be randomly selected from each group and asked to further participate in a one-time clinical evaluation. Addendum: Subjects will be recruited from community events and our clinic and research center.

You may qualify if:

  • Adults over 49 years old of either gender
  • Vision and hearing sufficient for compliance with tests

You may not qualify if:

  • Diagnosis by a physician of moderate or severe dementia
  • Intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Related Publications (1)

  • Scharre DW, Chang SI, Nagaraja HN, Vrettos NE, Bornstein RA. Digitally translated Self-Administered Gerocognitive Examination (eSAGE): relationship with its validated paper version, neuropsychological evaluations, and clinical assessments. Alzheimers Res Ther. 2017 Jun 27;9(1):44. doi: 10.1186/s13195-017-0269-3.

    PMID: 28655351DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Limitations and 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.

Results Point of Contact

Title
Douglas Scharre, MD
Organization
The Ohio State University
Doug.Scharre@osumc.edu
614-293-4969

Study Officials

  • Douglas Scharre, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2015

First Posted

September 9, 2015

Study Start

January 1, 2015

Primary Completion

November 13, 2024

Study Completion

November 13, 2024

Last Updated

March 25, 2025

Results First Posted

November 6, 2017

Record last verified: 2025-03

Locations

US(1)