Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 7:20 PM
Study NCT ID:
NCT03246269
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment (MoCA) - German version', 'timeFrame': 'Baseline', 'description': 'Total score of the MoCA'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Baseline', 'description': 'Total score of the MMSE'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'Baseline', 'description': 'Total score of the GDS'}, {'measure': "Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)", 'timeFrame': 'Baseline', 'description': 'Total score of the CERAD-NAB'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment', 'Cognitive Decline', 'Cognition Disorders', 'Cognitive Symptom', 'Cognitive Change', 'Cognitive Deterioration', 'Cognitive Abnormality', 'Cognitive Impairment, Mild', 'Cognition Disorders in Old Age', 'Dementia', 'Dementia Alzheimers', 'Dementia, Alzheimer Type', 'Dementia, Mild', 'Dementia of Alzheimer Type']}, 'descriptionModule': {'briefSummary': 'This observational cohort study in healthy volunteers establishes normative data for the German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible impacts of demographics on the MoCA total score.', 'detailedDescription': 'The Montreal Cognitive Assessment (MoCA) is a short tool to evaluate a multitude of cognitive domains (visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation). The original English MoCA consistently showed very high sensitivity and specificity in distinguishing patients with mild cognitive impairment from healthy controls. Therefore it is an excellent tool for early recognition of cognitive disorders. Based on a Canadian sample, the MoCA proposes a cut-off-value of 26/30 points. However, there is increasing evidence of intercultural differences in terms of the best cut-off-score. In addition the original version only slightly corrects for possible influences of education - an adjustment for age- or gender-related effects is missing. Therefore, the aim of our study was to investigate the possible impacts of demographics on the MoCA total score and to provide normative values for a German-speaking population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥65 years\n* Education ≥7 years\n* Fluency in the German language\n* Written informed consent\n\nExclusion Criteria:\n\n* History of cognitive impairment\n* Depression\n* Severe sensory or motor impairment interfering with cognitive testing\n* Serious somatic disease\n* Disease or event affecting the central nervous system\n* Cerebrovascular disease\n* Regular medication with psychoactive drugs except for benzodiazepines\n* Participation in a cognitive study within the last 3 months'}, 'identificationModule': {'nctId': 'NCT03246269', 'acronym': 'MoCA-Norm', 'briefTitle': 'Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)', 'orgStudyIdInfo': {'id': 'MoCA-Norm'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MoCA cohort', 'description': 'The German MoCA is administered once to all study participants.', 'interventionNames': ['Diagnostic Test: MoCA']}], 'interventions': [{'name': 'MoCA', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['MoCA cohort']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alessandra Thomann, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Felix Platter Hospital Basel'}, {'name': 'Nicolai Goettel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Raphael Monsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Manfred Berres, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Applied Sciences Koblenz'}, {'name': 'Andreas Monsch, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Felix Platter Hospital Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andreas Monsch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Andreas Monsch', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}