Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-04 @ 1:28 AM
Study NCT ID:
NCT02012595
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[11C]Donepezil PET For Imaging The Autonomous Nervous System 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': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-31', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution volume of [11C]donepezil in internal organs', 'timeFrame': 'The distribution volume of [11C]donepezil is measured at "Day 1" by PET/CT scanning each participant. The data analysis is done when all participants have completed the study.', 'description': "Our primary endpoint is the distribution volume of \\[11C\\]donepezil in internal organs (including salivary glands, heart, stomach and intestines) in Parkinson's patients compared to controls."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "AIM: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls.\n\nMATERIALS AND METHODS: We use the tracer \\[11C\\]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. Then PET/CT scans with \\[11C\\]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings.\n\nPERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's patients with moderate symptoms (diagnosis \\> 4 years earlier, bilateral disease). Will be recruited through department of neurology Aarhus University Hospital, Denmark.\n\nHealthy controls recruited through local media.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-80 years\n\nExclusion Criteria:\n\n* dementia,\n* psychiatric diseases,\n* serious medical illness including any type of previous cancer\n* any drug with known interaction with the autonomic nervous system\n* metal in the body (because of MRI scan)\n* pregnancy or breast feeding (because of radiation due to PET/CT)\n* known diseases of the salivary glands, stomach, intestines.\n* Prior major surgery to salivary glands, esophagus, stomach.'}, 'identificationModule': {'nctId': 'NCT02012595', 'briefTitle': '[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': '[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease', 'orgStudyIdInfo': {'id': '2013-01'}, 'secondaryIdInfos': [{'id': '2013-003775-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's patients", 'description': "Participants with Parkinson's Disease", 'interventionNames': ['Other: [11C]donepezil PET']}, {'label': 'Healthy Controls', 'description': 'Healthy participants', 'interventionNames': ['Other: [11C]donepezil PET']}], 'interventions': [{'name': '[11C]donepezil PET', 'type': 'OTHER', 'description': 'Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand \\[11C\\]donepezil', 'armGroupLabels': ['Healthy Controls', "Parkinson's patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Per Borghammer, MD, PhD,DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Per Borghammer', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Jascha Fonden', 'class': 'OTHER'}, {'name': 'Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, ph.d.,DMSci', 'investigatorFullName': 'Per Borghammer', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}