Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT04243304
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synaptic Density and Progression of Parkinson's Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Longitudinal study design (2 years follow up) where results of SV2A PET/CT, PE2I PET/MR and clinical rating scales are compared between PD patients and healthy controls.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2020-01-10', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline differences in synaptic density.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the baseline evaluation.', 'description': 'Baseline differences (%) in synaptic density between patients and controls.'}, {'measure': 'Correlations between clinical scores and synaptic density.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': 'Correlations between clinical scores and synaptic density in the patient group.'}, {'measure': 'Differences in the rate of decline of synaptic density.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': 'Differences (%) in the rate of decline of synaptic density between patients and controls.'}, {'measure': 'Correlations between progression of the clinical scores and decline of synaptic density.', 'timeFrame': 'Data analysis wel 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 in the patient group.'}], 'secondaryOutcomes': [{'measure': 'Baseline differences in DAT levels.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the baseline evaluation.', 'description': 'Baseline differences (%) in DAT levels between patients and controls.'}, {'measure': 'Correlations between clinical scores and DAT levels.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': 'Correlations between clinical scores and DAT levels in the patient group.'}, {'measure': 'Differences in the rate of decline of global and DAT levels.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': 'Differences (%) in the rate of decline of global and DAT levels between patients and controls.'}, {'measure': 'Correlations between progression of the clinical scores and decline of DAT levels.', 'timeFrame': 'Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.', 'description': 'Correlations between progression of the clinical scores and decline of DAT levels in the patient group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'PET', 'UCB-J', 'PE2I'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD.\n\nDESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease\n* Less than 5 years disease duration since motor symptom onset according to the patient\n* Hoehn-Yahr stage 1 or 2 in medication ON state\n* Capacity to understand the informed consent form\n\nExclusion Criteria:\n\n* Neuropsychiatric diseases other than PD\n* Major internal medical diseases\n* Relevant abnormalities on MR brain\n* History of alcohol or drug abuse\n* Contraindications for MR\n* Pregnancy\n* Previous participation in other research studies involving ionizing radiation with \\> 1 mSv over past 12 months."}, 'identificationModule': {'nctId': 'NCT04243304', 'briefTitle': "Synaptic Density and Progression of Parkinson's Disease.", 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': "Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.", 'orgStudyIdInfo': {'id': 's61477'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD patients', 'description': 'At baseline and 2-year follow-up', 'interventionNames': ['Other: 11C-UCB-J PET-CT', 'Other: 18F-PE2I PET-MR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls', 'description': 'At baseline and 2-year follow-up', 'interventionNames': ['Other: 11C-UCB-J PET-CT', 'Other: 18F-PE2I PET-MR']}], 'interventions': [{'name': '11C-UCB-J PET-CT', 'type': 'OTHER', 'description': 'Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.', 'armGroupLabels': ['Healthy controls', 'PD patients']}, {'name': '18F-PE2I PET-MR', 'type': 'OTHER', 'description': 'Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.', 'armGroupLabels': ['Healthy controls', 'PD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Wim Vandenberghe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Needs to be decided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}