Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 4:15 PM
Study NCT ID:
NCT06621758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Important issues in communication', 'timeFrame': 'From enrollment to the second questionnaire after 6 weeks', 'description': 'Rating of which issues are important for persons with SCD or MCI and their co-participant in the pre-diagnostic counseling and diagnostic disclosure communication.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['communication', 'biomarkers', 'counseling', 'diagnostic disclosure', 'MCI', 'SCD'], 'conditions': ['Alzheimer Disease', 'Mild Cognitive Impairment (MCI)', 'Subjective Cognitive Decline (SCD)']}, 'descriptionModule': {'briefSummary': 'The study investigate what information individuals with SCD or MCI and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed.', 'detailedDescription': 'Improved diagnostic work-up and the introduction of disease-modifying treatment have led to a shift towards earlier diagnosis. However, there are a need for better understanding of how best to communicate about biomarker use, assessment, and results in individuals with subjective cognitive decline (SCD) and mild cognitive impairment (MCI).\n\nObjective:\n\nThe overarching objective of this study is:\n\nTo understand what information individuals with SCD or MCI and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed.\n\nMethods: a prospective survey study Persons diagnosed with SCD or MCI and co-participants will be recruited consecutively from the memory clinic, Copenhagen University Hospital - Rigshospitalet (Denmark), Toulouse University Hospital, (France), University Medical Centre Ljubljana (Slovenia) and Universitair Ziekenhuis Brussel (Belgium)\n\nApproximately 30 persons and respective co-participants will be included from each hospital over a period of 12 months.\n\nEach participating person and co-participant will be asked to complete a very brief questionnaire immediately after disclosure of the diagnosis, and another questionnaire 2-6 weeks after the disclosure visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals diagnosed with SCD or MCI and co-participants will be recruited consecutively from the memory clinic, Copenhagen University Hospital - Rigshospitalet (Denmark), Toulouse University Hospital, (France), University Medical Centre Ljubljana (Slovenia) and Universitair Ziekenhuis Brussel (Belgium)\n\nApproximately 30 persons and respective co-participants will be included from each hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with SCD or MCI\n* Lumbar puncture performed during the diagnostic process\n* Age at or below 80 years\n* MMSE at or above 24\n\nExclusion Criteria:\n\n* Diagnosis of current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis)\n* Current excessive alcohol intake or substance abuse\n\nInclusion criteria for the co-participant:\n\n* Attended the diagnostic disclosure visit together with the individual diagnosed with SCD or MCI'}, 'identificationModule': {'nctId': 'NCT06621758', 'briefTitle': 'Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD', 'organization': {'class': 'NETWORK', 'fullName': 'Danish Dementia Research Centre'}, 'officialTitle': 'Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD', 'orgStudyIdInfo': {'id': 'F-24061891'}, 'secondaryIdInfos': [{'id': 'ERA PerMed JTC2021', 'type': 'OTHER', 'domain': 'European Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MCI', 'description': 'Individuals diagnosed with mild cognitive impairment (MCI)', 'interventionNames': ['Other: questionnaire']}, {'label': 'SCD', 'description': 'Individuals diagnosed with subjective cognitive decline (SCD)', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'Questionnaire regarding biomarker counseling and diagnostic disclosure', 'armGroupLabels': ['MCI', 'SCD']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marie Bruun, MD, PhD', 'role': 'CONTACT', 'email': 'marie.bruun@regionh.dk', 'phone': '+45 35451910'}, {'name': 'Kristian S Frederiksen, MD, PhD', 'role': 'CONTACT', 'email': 'kristian.steen.frederiksen@regionh.dk', 'phone': '+45 35456922'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Dementia Research Centre', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Toulouse University Hospital, Department of Geriatric & Internal Medicine, France', 'class': 'UNKNOWN'}, {'name': 'Universitair Ziekenhuis Brussel, Department of Neurology, Belgium', 'class': 'UNKNOWN'}, {'name': 'University Medical Centre Ljubljana, Department of Neurology, Slovenia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, clinical lector', 'investigatorFullName': 'Kristian Steen Frederiksen, MD', 'investigatorAffiliation': 'Danish Dementia Research Centre'}}}}