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

Cognitive Change Clinical Trial

— FOCUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712005
• Other study ID #: COG-FOCUS
• Status: Completed
• Start date: September 8, 2022
• Est. completion date: December 23, 2022

Study information

• Verified date: January 2023
• Source: Cognivue, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1437
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Cognivue, Inc.	Velocity Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stratify study population by age	Stratify study population by age compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.	4 months
Secondary	Stratify study population by sex	Stratify study population by sex compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.	4 months
Secondary	Stratify study population by education	Stratify study population by education compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.	4 months
Secondary	Stratify study population by ethnicity	Stratify study population by ethnicity compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.	4 months
Secondary	Training effect	Determine level of training effect.	4 months
Secondary	Compare test sensitivity	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