Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT04304859
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2019-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Assessment of Impaired Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2019-11-28', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Assessment of Impaired Cognition (BASIC)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Dementia and cognitive impairment cutoff 20/21'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['validation', 'casefinding tool'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - BASIC', 'detailedDescription': 'The case-finding instrument consists of four components: a. patient-directed questions, b. supermarket fluency, c. category-cued Memory Test, d. informant-directed questions.\n\nThe data collection was carried out at five outpatient memory clinics in Denmark'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Cases: Patients referred from GP for diagnostic evaluation Controls: Participating patients' relatives and volunteers from ongoing research projects at the involved memory clinics.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fluent in Danish\n\nExclusion Criteria:\n\n* impaired eyesight or hearing'}, 'identificationModule': {'nctId': 'NCT04304859', 'acronym': 'BASIC', 'briefTitle': 'Brief Assessment of Impaired Cognition', 'organization': {'class': 'NETWORK', 'fullName': 'Danish Dementia Research Centre'}, 'officialTitle': 'Brief Assessment of Impaired Cognition', 'orgStudyIdInfo': {'id': 'NVD-2019-01'}, 'secondaryIdInfos': [{'id': '1604063', 'type': 'OTHER_GRANT', 'domain': 'Danish Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases referred from GP', 'description': 'BASIC (Brief Assessment of Impaired Cognition) MMSE (Mini Mental State Examination) Extensive diagnostic work-up including clinical interview, neurological and physical examination, laboratory screening tests, structural neuroimaging', 'interventionNames': ['Diagnostic Test: BASIC']}, {'label': 'Healthy controls', 'description': 'Test performed:\n\nBASIC MMSE GDS-15 (Geriatric Depression Scale)', 'interventionNames': ['Diagnostic Test: BASIC']}], 'interventions': [{'name': 'BASIC', 'type': 'DIAGNOSTIC_TEST', 'description': 'Validation', 'armGroupLabels': ['Cases referred from GP', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'DDRC', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Gunhild Waldemar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Danish Dementia Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Dementia Research Centre', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}