Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-02-28 @ 11:42 PM
Study NCT ID:
NCT06626412
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal SV2A and MRI in Premanifest HD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline differences in synaptic density.', 'timeFrame': 'Data analysis will be done when all subjects have undergone the baseline evaluation.', 'description': 'Baseline differences in (regional) synaptic density between premanifest HD and controls.'}, {'measure': 'Baseline differences in brain volume.', 'timeFrame': 'Data analysis will be done when all subjects have undergone the baseline evaluation.', 'description': 'Baseline differences in (regional) brain volume between premanifest HD and controls.'}, {'measure': 'Differences in the rate of decline of synaptic density.', 'timeFrame': 'Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': '* Differences in the rate of decline of (regional) synaptic density between patients and controls.\n* Sensitivity to change for synaptic density.'}, {'measure': 'Differences in the rate of decline of volumetric MRI.', 'timeFrame': 'Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': '* Differences in the rate of decline of (regional) brain volumes between patients and controls.\n* Sensitivity to change for (regional) brain volumes.'}], 'secondaryOutcomes': [{'measure': 'Baseline correlations between clinical scores and regional synaptic density or brain volume.', 'timeFrame': 'Data analysis will be done when all subjects have undergone the baseline evaluation.', 'description': 'Correlations between clinical scores and regional synaptic density or regional volume loss in the patient group at baseline.'}, {'measure': 'Correlations between progression of the clinical scores and decline of synaptic density or brain volume.', 'timeFrame': 'Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': 'Correlations between progression of the clinical scores and decline of synaptic density or regional volume loss in the patient group, after longitudinal follow up of 2 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET', 'MRI', 'SV2A', 'synaptic density', '18F-SynVesT-1'], 'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': 'AIM: to compare the sensitivity of SV2A PET and volumetric MRI to detect longitudinal striatal changes in premanifest HD.\n\nDESIGN: The investigators will include late premanifest HD mutations carriers and matched healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 18F-SynVesT-1 PET and volumetric MRI at baseline and after 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-75 years inclusive.\n* Capacity to understand the informed consent form.\n* HD mutation carriers:\n\n * HTT (CAG)n ≥ 40\n * HD-ISS \\< 2\n * CAP100 score \\> 70\n\nExclusion Criteria:\n\n* neuropsychiatric diseases (other than HD for HD mutation carriers)\n* major internal medical diseases\n* white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities\n* history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse\n* contraindications for MR\n* pregnancy\n* previous participation in other research studies involving ionizing radiation with more than 1 mSv in the previous 12 months.'}, 'identificationModule': {'nctId': 'NCT06626412', 'briefTitle': 'Longitudinal SV2A and MRI in Premanifest HD', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': "Longitudinal Imaging of Striatal Synaptic Density and Volume in People With Premanifest Huntington's Disease.", 'orgStudyIdInfo': {'id': 'S69109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premanifest HD', 'description': 'At baseline and 2-year follow-up', 'interventionNames': ['Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET', 'Diagnostic Test: Volumetric MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'At baseline and 2-year follow-up', 'interventionNames': ['Diagnostic Test: Diagnostic Test: 18F-SynVesT-1 PET', 'Diagnostic Test: Volumetric MRI']}], 'interventions': [{'name': 'Diagnostic Test: 18F-SynVesT-1 PET', 'type': 'DIAGNOSTIC_TEST', 'description': 'Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 18F-SynVesT-1.', 'armGroupLabels': ['Healthy controls', 'Premanifest HD']}, {'name': 'Volumetric MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Magnetic resonance imaging of brain volume.', 'armGroupLabels': ['Healthy controls', 'Premanifest HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Wim Vandenberghe, MD, PhD', 'role': 'CONTACT', 'email': 'wim.vandenberghe@uzleuven.be', 'phone': '+3216342553'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}