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

Cognivue

Status: Completed

Conditions: Cognitive Change

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05712005

COG-FOCUS

Details and patient eligibility

About

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.

Enrollment: 1,437 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,437 participants in 3 patient groups

Group 1

Description:

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

Description:

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

Description:

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.