Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT06084533
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-28
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CS1P1 PET Studies of Neuroinflammation in Parkinson 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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Parkinson Disease.', 'timeFrame': 'At the time of PET scan', 'description': 'The investigators hypothesize that specific binding of \\[11C\\]-CS1P1 is elevated in participants with neurodegenerative disease of the central nervous system compared to healthy control participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Parkinson disease (PD) is a progressive neurological disorder strongly linked to advancing age that results in decline in mobility and thinking. Based on prior research, the investigators think that small amounts of inflammation in the brain may contribute to the mobility and thinking problems in people with PD. They are trying to measure inflammation in the brain in order to understand how this inflammation could be contributing to the symptoms of PD. This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called \\[11C\\]-CS1P1 to identify inflammation in the brain.The goal of this project is to quantify neuroinflammation with \\[11C\\]-CS1P1 PET and compare to motor and cognitive function in participants with various stages of severity of PD compared to controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 50 participants with idiopathic PD and up to 30 healthy control participants are to be studied. Some of these participants will be recruited from existing research studies. Others will be recruited from the clinic, the community, and a registry of healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parkinson Disease (PD) participants must be at least 50 years old and meet clinical diagnostic criteria of idiopathic PD.\n* Control participants must be at least 50 years old and not have PD, no first-degree family member with PD, and no evidence of PD or dementia on examination.\n\nExclusion Criteria:\n\n* any history of other neurologic illness (e.g. stroke, seizure, multiple sclerosis)\n* history of brain surgery or major head trauma\n* major medical/systemic illness\n* severe psychiatric illness (e.g. bipolar disorder, schizophrenia)\n* major drug abuse\n* history of long term use of anti-dopaminergic medication\n* chronic treatment with immunomodulatory or anti-inflammatory medications\n* weight over 300 lbs\n* contraindication to or inability to tolerate MRI'}, 'identificationModule': {'nctId': 'NCT06084533', 'briefTitle': 'CS1P1 PET Studies of Neuroinflammation in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'CS1P1 PET Studies of Neuroinflammation in Parkinson Disease', 'orgStudyIdInfo': {'id': '202306067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parkinson Disease', 'interventionNames': ['Drug: [11C]-CS1P1']}, {'label': 'Healthy Control', 'interventionNames': ['Drug: [11C]-CS1P1']}], 'interventions': [{'name': '[11C]-CS1P1', 'type': 'DRUG', 'description': 'Participants will receive a single intravenous bolus injection of 10.0 - 20.0 milliCurie (mCi) of the investigational radiotracer \\[11C\\]-CS1P1. Participants will then undergo a \\[11C\\]-CS1P1 PET scan.', 'armGroupLabels': ['Healthy Control', 'Parkinson Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63105', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Robert L White, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}