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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cognitive Change

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Training effect | Determine level of training effect. | 4 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, brain neurology, neuropsychology, brain health, digital cognitive testing, digital biomarkers, computerized cognititve testing