Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05712005
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2022-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1437}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmation of scoring and normative ranges.', 'timeFrame': '4 months', 'description': 'Confirmation of scoring and normative ranges in Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.'}], 'secondaryOutcomes': [{'measure': 'Stratify study population by age', 'timeFrame': '4 months', 'description': 'Stratify study population by age compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.'}, {'measure': 'Stratify study population by sex', 'timeFrame': '4 months', 'description': 'Stratify study population by sex compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.'}, {'measure': 'Stratify study population by education', 'timeFrame': '4 months', 'description': 'Stratify study population by education compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.'}, {'measure': 'Stratify study population by ethnicity', 'timeFrame': '4 months', 'description': 'Stratify study population by ethnicity compared to normative ranges of Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests.'}, {'measure': 'Training effect', 'timeFrame': '4 months', 'description': 'Determine level of training effect.'}, {'measure': 'Compare test sensitivity', 'timeFrame': '4 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognition', 'brain neurology', 'neuropsychology', 'brain health', 'digital cognitive testing', 'digital biomarkers', 'computerized cognititve testing'], 'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll up to 2,000 subjects at up to 20 study sites throughout the United States. Subjects will be divided into 6 age groups (i.e., 18-29; 30-39; 40-49; 50-59; 60-69; 70 and above). Subjects will complete one visit lasting up to two hours.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and older\n* Fluent in English\n* Full vision in at least one eye\n* Full use of at least one functional hand\n* In overall good health, not experiencing any acute symptoms\n* Agrees to cognitive examinations administered by research team\n\nExclusion Criteria:\n\n* Age under 18\n* Not fluent in English\n* Blind in both eyes (any level of diagnosed blindness)\n* Lacking a functional hand\n* Those entering or in hospice\n* Inability to agree to cognitive examinations administered by research team'}, 'identificationModule': {'nctId': 'NCT05712005', 'acronym': 'FOCUS', 'briefTitle': 'Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cognivue, Inc.'}, 'officialTitle': 'Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study (FOCUS)', 'orgStudyIdInfo': {'id': 'COG-FOCUS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.'}, {'label': '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.'}, {'label': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'James Galvin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cognivue, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Velocity Clinical Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}