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

Completed
Conditions
Cognitive Change
Registration Number
NCT05712005
Lead Sponsor
Cognivue, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1437
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Confirmation of scoring and normative ranges.4 months

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

Secondary Outcome Measures
NameTimeMethod
Stratify study population by age4 months

Stratify study population by age compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

Stratify study population by sex4 months

Stratify study population by sex compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

Stratify study population by education4 months

Stratify study population by education compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

Stratify study population by ethnicity4 months

Stratify study population by ethnicity compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.

Training effect4 months

Determine level of training effect.

Compare test sensitivity4 months

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

Trial Locations

Locations (1)

Velocity Clinical Research

🇺🇸

Durham, North Carolina, United States

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