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

NCT05712005 | Completed

• 1 other identifier: COG-FOCUS
• Study Type: observational
• Target: 1,437
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Change

Keywords

cognition; brain neurology; neuropsychology; brain health; digital cognitive testing; digital biomarkers; computerized cognititve testing

Outcome Measures

Primary Outcomes (1)

• Confirmation of scoring and normative ranges.

  Confirmation of scoring and normative ranges in Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

  4 months

Secondary Outcomes (6)

• Stratify study population by age

  4 months

• Stratify study population by sex

  4 months

• Stratify study population by education

  4 months

• Stratify study population by ethnicity

  4 months

• Training effect

  4 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cognivue, Inc.: lead
• Velocity Clinical Research: collaborator

Study Sites (1)

Velocity Clinical Research

Durham, North Carolina, 27701, United States

Location

Study Officials

• James Galvin, MD, MPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: February 3, 2023
• Study Start: September 8, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)