Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-04 @ 4:14 PM
Study NCT ID:
NCT03555292
Status:
UNKNOWN
Last Update Posted:
2018-06-13
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2021-10-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amyloid burden range in all subjects', 'timeFrame': '1 week', 'description': 'Outcome Measures: All patients underwent a 90-min dynamic 11C-PIB PET scan. 11C-PiB distribution volume ratio (DVR) will be estimated by using the PMOD software.'}], 'secondaryOutcomes': [{'measure': 'The cognitive scores in all patients', 'timeFrame': '0, 6month, 1year', 'description': 'Functional status is assessed by the Mini-Mental State Examination (MMSE). Parkinson disease with mild cognitive impairment：MMSE score 24-28; Parkinson disease with dementia: MMSE score ≤24; Parkinson disease with normal cognition: MMSE score \\>28.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['11C-PIB', "Parkinson's disease", 'dementia', 'mild cognitive impairment'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "To evaluate the potential contribution of amyloid burden, as indexed by 11C-Pittsburgh compound B (PiB) retention, to the progression of cognitive impairments in patients with Parkinson's disease(PD).", 'detailedDescription': 'Study design:\n\nMulti-center, Five-arm\n\nSubjects:\n\nPatients with PD without dementia; Patients with PD with mild cognitive impairment (MCI); Patients with PD with dementia; Patients with a dementia with Lewy bodies(DLB); Healthy person\n\nSample size:\n\n200, including a PD without dementia group of 75 patients, a PD with MCI group of 30 patients, a PD with dementia group of 20 patients, a DLB group of 25 patients and a normal control group of 50 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with Parkinson's disease and parkinsonian dementia syndromes\n2. Males and females, ≥40 years old\n3. The diagnosis of PD is established using the UK Parkinson's Disease Society Brain Bank Research Center Clinical diagnostic criteria. Criteria for PD-MCI and PD-dementia are consistent with those of the Movement Disorder Society. The DLB Consortium consensus criteria are used for DLB.\n4. They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.\n\nExclusion Criteria:\n\n1. Females planning to bear a child recently or with childbearing potential\n2. Renal function: serum creatinine \\>3.0 mg/dL (270 μM/L)\n3. Liver function: any hepatic enzyme level more than 5 times upper limit of normal.\n4. Known severe allergy or hypersensitivity to IV radiographic contrast.\n5. Patients not able to enter the bore of the PET/CT scanner.\n6. Inability to lie still for the entire imaging time because of cough, pain, etc.\n7. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.\n8. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.\n\n \\-"}, 'identificationModule': {'nctId': 'NCT03555292', 'briefTitle': "11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes", 'organization': {'class': 'OTHER', 'fullName': 'Oriental Neurosurgery Evidence-Based-Study Team'}, 'officialTitle': "Safety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes", 'orgStudyIdInfo': {'id': 'CPBD2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD without dementia', 'description': '11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.', 'interventionNames': ['Drug: 11C-PiB']}, {'type': 'EXPERIMENTAL', 'label': 'PD with MCI', 'description': '11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.', 'interventionNames': ['Drug: 11C-PiB']}, {'type': 'EXPERIMENTAL', 'label': 'PD with dementia', 'description': '11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.', 'interventionNames': ['Drug: 11C-PiB']}, {'type': 'EXPERIMENTAL', 'label': 'dementia with Lewy bodies', 'description': '11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.', 'interventionNames': ['Drug: 11C-PiB']}, {'type': 'EXPERIMENTAL', 'label': 'healthy control', 'description': '11C-PIB injection and PET/CT scan The subjects were intravenously injected with 555MBq 11C-PIB and underwent PET/CT scan immediately after the injection.', 'interventionNames': ['Drug: 11C-PiB']}], 'interventions': [{'name': '11C-PiB', 'type': 'DRUG', 'description': '11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans', 'armGroupLabels': ['PD with MCI', 'PD with dementia', 'PD without dementia', 'dementia with Lewy bodies', 'healthy control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking Tian Tan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Li Cai, PhD', 'role': 'CONTACT', 'email': 'XCL242004@126.com', 'phone': '86-22-60362190'}], 'overallOfficials': [{'name': 'Shuo Gao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tianjin Medical University General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oriental Neurosurgery Evidence-Based-Study Team', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}