Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study (FOCUS)

January 25, 2023 updated by: Cognivue, Inc.

Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study (FOCUS)

An open-label, multi-site, validity and reliability study to obtain data on the Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests to assess scoring and normative ranges and compare against other cognitive tests within a diverse population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1437

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Velocity Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will enroll up to 2,000 subjects at up to 20 study sites throughout the United States. Subjects will be divided into 6 age groups (i.e., 18-29; 30-39; 40-49; 50-59; 60-69; 70 and above). Subjects will complete one visit lasting up to two hours.

Description

Inclusion Criteria:

  • Age 18 and older
  • Fluent in English
  • Full vision in at least one eye
  • Full use of at least one functional hand
  • In overall good health, not experiencing any acute symptoms
  • Agrees to cognitive examinations administered by research team

Exclusion Criteria:

  • Age under 18
  • Not fluent in English
  • Blind in both eyes (any level of diagnosed blindness)
  • Lacking a functional hand
  • Those entering or in hospice
  • Inability to agree to cognitive examinations administered by research team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1
Study participants assigned to this group will complete the Cognivue 5-Minute Screening test across three domains including Memory, Visuospatial and Executive Function as well as two performance measures of Reaction Time and Speed Processing along with Normative Ranges 3 times OR study participants assigned to this group will complete the Cognivue 10-Minute Assessment test across six domains including Memory, Visuospatial, Executive Function, Naming/Language, Memory, Delayed Recall and Abstraction, as well as two performance measures of Reaction Time and Speed Processing, along with Normative Ranges 3 times. Next, study subjects will complete up to eight additional neuropsychological assessments, intermittently separated followed by the Cognivue Plus test.
Group 2
Study subjects will complete up to eight additional neuropsychological assessments, intermittently separated followed by the Cognivue Plus test. Next, study participants assigned to this group will complete the Cognivue 5-Minute Screening test across three domains including Memory, Visuospatial and Executive Function as well as two performance measures of Reaction Time and Speed Processing along with Normative Ranges 3 times OR study participants assigned to this group will complete the Cognivue 10-Minute Assessment test across six domains including Memory, Visuospatial, Executive Function, Naming/Language, Memory, Delayed Recall and Abstraction, as well as two performance measures of Reaction Time and Speed Processing, along with Normative Ranges 3 times.
Group 3
Study subjects will complete the Cognivue Plus test followed by completing up to eight additional neuropsychological assessments, intermittently separated. Next, study participants assigned to this group will complete the Cognivue 5-Minute Screening test across three domains including Memory, Visuospatial and Executive Function as well as two performance measures of Reaction Time and Speed Processing along with Normative Ranges 3 times OR study participants assigned to this group will complete the Cognivue 10-Minute Assessment test across six domains including Memory, Visuospatial, Executive Function, Naming/Language, Memory, Delayed Recall and Abstraction, as well as two performance measures of Reaction Time and Speed Processing, along with Normative Ranges 3 times.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Confirmation of scoring and normative ranges.
Time Frame: 4 months
Confirmation of scoring and normative ranges in Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stratify study population by age
Time Frame: 4 months
Stratify study population by age compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.
4 months
Stratify study population by sex
Time Frame: 4 months
Stratify study population by sex compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.
4 months
Stratify study population by education
Time Frame: 4 months
Stratify study population by education compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.
4 months
Stratify study population by ethnicity
Time Frame: 4 months
Stratify study population by ethnicity compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.
4 months
Training effect
Time Frame: 4 months
Determine level of training effect.
4 months
Compare test sensitivity
Time Frame: 4 months
Comparison of test sensitivity between Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests and other cognitive assessment tests including: Reaction Time, Digit Span, Stroop and Visual Go No Go. In addition, RBANS and D-KEFS will be used as Cognitive Validators
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cognivue, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Velocity Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Galvin, MD, MPH, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COG-FOCUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings