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

N/ACompletedNCT05712005

Cognivue, Inc.1,437 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,437

Conditions

Cognitive Change

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Velocity Clinical Research

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Confirmation of scoring and normative ranges.

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

Time frame: 4 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 4 months

Training effect

Determine level of training effect.

Time frame: 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

Data from ClinicalTrials.gov

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