Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-28 @ 6:00 PM
Study NCT ID:
NCT05624632
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2022-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Remote Assessment Using FLAME (CRA-FLAME)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLAME global composite score', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'calculated by combining information from two web-based online neuropsychological test batteries that are already integrated in a unique platform: the PROTECT Cognitive Tests System (PCTS) (Corbett et al., 2015) and the CogTrackTM (Wesnes et al., 2017)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.\n\nParticipants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC\\_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)', 'detailedDescription': 'We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.\n\nParticipants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC\\_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are individuals that have participated/are participating in BBRC-sponsored studies.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants must meet ALL the following criteria:\n\n1. To sign the study informed consent form approved by the corresponding authorities.\n2. Men and women that have participated/are participating in a BBRC-sponsored study.\n3. To accept that:\n\n * The results obtained in this study may be published in scientific journals and at BBRC's communication channels (e.g. web page)\n * The data gathered may be used in combination with those gathered in other BBRC-sponsored studies in which they may (have) participate(d)\n\nExclusion Criteria:\n\n1\\. Not having an ICT literacy enough to access and complete the online tests."}, 'identificationModule': {'nctId': 'NCT05624632', 'briefTitle': 'Cognitive Remote Assessment Using FLAME (CRA-FLAME)', 'organization': {'class': 'OTHER', 'fullName': 'Barcelonabeta Brain Research Center, Pasqual Maragall Foundation'}, 'officialTitle': 'Cognitive Remote Assessment Using FLAME (CRA-FLAME)', 'orgStudyIdInfo': {'id': 'CRA- FLAME/BBRC2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cognitively unimpaired', 'description': 'Cognitively unimpaired participants from BBRC-sponsored studies', 'interventionNames': ['Other: Remote cognitive testing']}], 'interventions': [{'name': 'Remote cognitive testing', 'type': 'OTHER', 'description': 'Remote cognitive testing', 'armGroupLabels': ['Cognitively unimpaired']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08005', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'BarcelonaBeta Brain Research Center', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barcelonabeta Brain Research Center, Pasqual Maragall Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}