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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05712005

Acronym

FOCUS

Enrollment

1437

Registered

2023-02-03

Start date

2022-09-08

Completion date

2022-12-23

Last updated

2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change

Keywords

cognition, brain neurology, neuropsychology, brain health, digital cognitive testing, digital biomarkers, computerized cognititve testing

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results