NCT04265898

Brief Summary

Currently, cognitive screening is performed in-person after the individual expresses symptoms or it is noticed by someone close to them and are largely done in clinical settings. The digital Virginia Tech Carilion Cognitive Examination (VTC-Cog) utilizes smart devices and allows for the early establishment of an individual's cognitive baseline. VTC-Cog has been designed to test all major aspects of cognition, as currently assessed using the Montreal Cognitive Assessment (MoCA) and Mini-Mental Status Examination (MMSE) but on a digital platform. The VTC-Cog allows for standardized scoring with no clinician bias and provides a clinician report that breaks down distinct changes in different areas of cognition (executive, visuospatial, memory, etc.) in order to refine clinician analysis.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

1.6 years

First QC Date

February 10, 2020

Last Update Submit

August 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment

    18-24 months

Study Arms (2)

Test Group

Reported mild cognitive deficits

Device: The Digital Virginia Tech Carilion Cognitive Examination

Control Group

No cognitive deficits

Device: The Digital Virginia Tech Carilion Cognitive Examination

Interventions

Completion of a newly developed digital cognitive screen

Control GroupTest Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants must be 50-80 years old with no diagnosis of dementia who speak English, have no acute mental health concerns, and have a Carilion Clinic medical provider.

You may qualify if:

  • Age 50-80 years
  • No current diagnosis of dementia
  • Current stable mental health
  • English speaker
  • Carilion Clinic Medical Provider

You may not qualify if:

  • \<50 years old or \>80 years old
  • Current diagnosis of dementia
  • Unstable mental health
  • Non-English speaker
  • Medical provider outside the Carilion Clinic system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Azziza Bankole, MD

    Physician

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

May 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 10, 2020

Record last verified: 2020-08