Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06286293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2024-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social cognitive performance', 'timeFrame': '2024-2027', 'description': 'Social cognition in bvYOD, compared to non-bvYOD, patients with frontal brain injury and healthy controls'}], 'secondaryOutcomes': [{'measure': 'Association between social cognition and risky decision-making', 'timeFrame': '2024-2027', 'description': 'Association between several aspect of social cognition (i.e. emotion recognition, empathy, theory of mind, emotion experience) and risk-taking behaviour.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Young-onset Dementia']}, 'referencesModule': {'references': [{'pmid': '40424326', 'type': 'DERIVED', 'citation': 'Gelmers F, Huitema RB, Scheenen ME, van Munster BC, Spikman JM; YOD-INCLUDED Consortium. Assessing social cognition and risk-taking behaviour in patients with young-onset dementia: Study protocol for the YOD-RiSoCo observational prospective cohort study. PLoS One. 2025 May 27;20(5):e0324517. doi: 10.1371/journal.pone.0324517. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about social cognition and risky behaviour in patients with young-onset dementia (YOD). The investigators want to\n\n* Examine differences in performance on social cognition test and measures of risky behaviour between behavioural variant YOD patients, patients with frontal brain injury, non-behavioural YOD patients and healthy controls.\n* Examine if there is a relation between social cognition tests and measures of risky behaviour.\n\nParticipants will be administered a neuropsychological assessment including social cognition measures and patients will complete a driving simulator task in which risky behaviour will be elicited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with young-onset dementia, i.e. onset of dementia before the age of 65 years.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll subjects\n\n* Sufficient command of the Dutch language\n* In possession of a driver's license with any driving experience throughout life\n* Age 18 to 65\n\nbvYOD subjects\n\n* Probable diagnosis of young-onset dementia (before 65 years old), confirmed after interdisciplinary consensus meeting in which interviews, neuropsychological examination, neurological and psychiatric assessments, neuro-imaging, blood samples, and in some cases FDG/PIB-PETscans, CSF biomarkers or genetic counseling were discussed.\n* Nosological diagnosis of bvFTD or bvAD\n\nNon-bvYOD subjects\n\n* Probable diagnosis of young-onset dementia (before 65 years old), confirmed after interdisciplinary consensus meeting in which interviews, neuropsychological examination, neurological and psychiatric assessments, neuro-imaging, blood samples, and in some cases FDG/PIB-PETscans, CSF biomarkers or genetic counseling were discussed.\n* YOD subtypes other dan bvFTD or bvAD, such as amnestic variant AD.\n\nFrontal brain injury subjects\n\n\\- Neurological patients with frontal brain injury (e.g. traumatic brain injury, stroke or brain tumor patients).\n\nExclusion Criteria:\n\nAll subjects\n\n* Suffering from severe motion sickness; motion sickness is a risk factor for simulator sickness\n\nYOD subjects:\n\n\\- Presence of premorbid severe neurological or psychiatric pathology, non-related to dementia.\n\nFrontal brain injury subjects:\n\n\\- Presence of serious psychiatric disorders or other neurological comorbidities.\n\nHealthy control subjects:\n\n* Presence of serious psychiatric disorders\n* History of neurological disorders, which may interfere with cognitive functioning (e.g. recent concussion, previous subarachnoid or intracerebral haemorrhage, intracranial tumours, epilepsy, ischemic stroke)."}, 'identificationModule': {'nctId': 'NCT06286293', 'acronym': 'YOD-RiSoCo', 'briefTitle': 'YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'YOD-RiSoCo: the Role of Social Cognition and Better Identification of Risk-taking Behaviour in Patients with Young-onset Dementia', 'orgStudyIdInfo': {'id': '18171'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bvYOD', 'description': 'Neuropsychological assessment and driving simulator task.', 'interventionNames': ['Other: Neuropsychological assessment, driving simulator task']}, {'label': 'non-bvYOD', 'description': 'Neuropsychological assessment and driving simulator task.', 'interventionNames': ['Other: Neuropsychological assessment, driving simulator task']}, {'label': 'Patients with frontal brain damage', 'description': 'Neuropsychological assessment and driving simulator task.', 'interventionNames': ['Other: Neuropsychological assessment, driving simulator task']}, {'label': 'Healthy controls', 'description': 'Neuropsychological assessment and driving simulator task.', 'interventionNames': ['Other: Neuropsychological assessment, driving simulator task']}], 'interventions': [{'name': 'Neuropsychological assessment, driving simulator task', 'type': 'OTHER', 'description': 'Neuropsychological assessment consisting of test measuring general cognitive abilities and social cognition. Driving simulator task measuring risk-taking.', 'armGroupLabels': ['Healthy controls', 'Patients with frontal brain damage', 'bvYOD', 'non-bvYOD']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gelmers', 'role': 'CONTACT', 'email': 'f.gelmers@umcg.nl', 'phone': '+31 50 361 46 64'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}