Cognitive ChangeVTC-CogNCT04265898
Validating the Digital Virginia Tech Carilion Cognitive Examination
An observational study of Cognitive Change, run by Carilion Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- The Digital Virginia Tech Carilion Cognitive Examination
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 50-80 years
- No current diagnosis of dementia
- Current stable mental health
- English speaker
- Carilion Clinic Medical Provider
Who cannot join
- <50 years old or >80 years old
- Current diagnosis of dementia
- Unstable mental health
- Non-English speaker
- Medical provider outside the Carilion Clinic system
About this study
Official title: Validating the Digital Virginia Tech Carilion Cognitive Examination - A Unique Tool for Cognitive Assessment
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.
- Conditions
- Cognitive Change
- Being tested
- The Digital Virginia Tech Carilion Cognitive Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Digital Virginia Tech Carilion Cognitive ExaminationDevice
Completion of a newly developed digital cognitive screen
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Reported mild cognitive deficits Receives: Device: The Digital Virginia Tech Carilion Cognitive Examination | |
| Control Group | No cognitive deficits Receives: Device: The Digital Virginia Tech Carilion Cognitive Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: The study did not receive IRB approval and was withdrawn by the PI on April 9, 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Digitally Enhanced Screening Applications
- Responsible party
- Sponsor
- Investigators
- Azziza Bankole, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265898
- Sponsor's protocol ID
- VTC-Cog 19-554
- Acronym
- VTC-Cog
- Status last verified
- Aug 2020
- First submitted
- 10 Feb 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Digital Virginia Tech Carilion Cognitive Examination - A Unique Tool for Cognitive Assessment
- ClinicalTrials.gov ID
- NCT04265898
- Acronym / sponsor ID
- VTC-Cog / VTC-Cog 19-554
- Conditions
- Cognitive Change
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study did not receive IRB approval and was withdrawn by the PI on April 9, 2020.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Digitally Enhanced Screening Applications
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Device: The Digital Virginia Tech Carilion Cognitive ExaminationReported mild cognitive deficits |
| Control Group | – | Device: The Digital Virginia Tech Carilion Cognitive ExaminationNo cognitive deficits |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age 50-80 years
- No current diagnosis of dementia
- Current stable mental health
- English speaker
- Carilion Clinic Medical Provider
Key exclusion criteria (5 listed)
- <50 years old or >80 years old
- Current diagnosis of dementia
- Unstable mental health
- Non-English speaker
- Medical provider outside the Carilion Clinic system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Digital Virginia Tech Carilion Cognitive ExaminationCompletion of a newly developed digital cognitive screen | Device | Control Group, Test Group |
Primary outcome
Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment
Time frame: 18-24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azziza Bankole, MD principal investigator
Physician
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change, run by Carilion Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the Digital Virginia Tech Carilion Cognitive Examination against the Montreal Cognitive Assessment (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.