Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-02 @ 3:15 PM
Study NCT ID:
NCT03554551
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2018-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging the Vesicular Acetylcholine Transporter Using 18F-FEOBV PET in Parkinsons 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Density of vesicular acetylcholine transporter', 'timeFrame': 'Day 1', 'description': 'Average density will be determined in each group for intestine, pancreas, suprarenal gland, heart and relevant areas of the brain. Group differences will be calculated'}], 'secondaryOutcomes': [{'measure': 'Correlation to measurements of gastrointestinal denervation', 'timeFrame': 'Day 1', 'description': 'Density of vesicular acetylcholine transporter will be correlated to symptoms of gastrointestinal autonomic denervation (constipation, gastroparesis).'}, {'measure': 'Correlation to measurements of dysautonomia', 'timeFrame': 'Day 1', 'description': 'Density of vesicular acetylcholine transporter will be correlated to measurements of dysautonomia (orthostatic hypotension, colon transit time)'}, {'measure': 'Correlation to measurements of neuropsychological tests', 'timeFrame': 'Day 1', 'description': 'Cerebral density of vesicular acetylcholine transporter is correlated with neuropsychological test scores.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parasympathetic'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '35362761', 'type': 'DERIVED', 'citation': 'Horsager J, Okkels N, Van Den Berge N, Jacobsen J, Schact A, Munk OL, Vang K, Bender D, Brooks DJ, Borghammer P. In vivo vesicular acetylcholine transporter density in human peripheral organs: an [18F]FEOBV PET/CT study. EJNMMI Res. 2022 Apr 1;12(1):17. doi: 10.1186/s13550-022-00889-9.'}]}, 'descriptionModule': {'briefSummary': "Patients with Parkinson's disease (PD) often display symptoms, such as constipation, due to denervation of the cholinergic nerves in the gut. It has been hypothesized that PD initiates in the gut years prior to diagnosis. To gain a detailed understanding of the early stages of PD, techniques for quantification of cholinergic nerves are needed. The PET tracer 18F-FEOBV binds specifically to the vesicular acetylcholine transporter, situated in presynaptic cholinergic nerve terminals. The investigators will investigate 18F-FEOBV uptake in the brain and internal organs of 15 patients with moderate-stage PD and compare to 15 healthy controls. Furthermore, findings are correlated to validated clinical tests of the autonomic nervous system. The aim is to validate 18F-FEOBV PET/CT as a clinical imaging modality to diagnose parasympathetic denervation in PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parkinson patients are moderate stage disease. Healthy subjects have to meet the criteria below.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parkinsons disease, disease duration \\> 4 years, Hoehn \\& Yahr stage 2-3\n\nExclusion Criteria:\n\n* Significant neurological diseases (e.g. stroke, tumor)\n* Significant psychiatric disease\n* Previous major surgery on thoracic and/or abdominal organs\n* Significant medical disease (e.g. heart- or liver failure)\n* Inflammatory bowel disease\n* Gluten intolerance\n* Diabetes\n* Magnetic Resonance (MR) contraindications (metal in body, claustrophobia)\n* Allergy to CT-contrast fluid\n* Pacemaker\n* Any current or previous cancer involving internal organs\n* Peripheral neuropathy (except Parkinsons disease related)'}, 'identificationModule': {'nctId': 'NCT03554551', 'briefTitle': 'Imaging the Vesicular Acetylcholine Transporter Using 18F-FEOBV PET in Parkinsons Disease', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Imaging the Vesicular Acetylcholine Transporter Using 18Fluoro-fluoroethoxybenzovesamicol (18F-FEOBV) Positron Emission Tomography(PET) in Parkinsons Disease', 'orgStudyIdInfo': {'id': 'FEO-PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Parkinsons disease', 'description': 'Disease duration \\> 4 years, Hoehn \\& Yahr stage 2-3, 50-85 years old'}, {'label': 'Healthy controls', 'description': '50-85 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Region Midt', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jacob Horsager', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}