Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-24 @ 5:34 AM
Study NCT ID:
NCT05527067
Status:
RECRUITING
Last Update Posted:
2023-03-23
First Post:
2022-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registered Cohort Study on α-Synucleinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2022-08-28', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UPDRS /UMSARS scores', 'timeFrame': 'Baseline', 'description': "Disease severity was evaluated by the neurologist using the united Parkinson's disease rating scale (UPDRS) or united multiple system atrophy rating scale (UMSARS) separately as diagnosed."}], 'secondaryOutcomes': [{'measure': 'H&Y stage', 'timeFrame': 'Baseline', 'description': 'The Hoehn and Yahr （H\\&Y)'}, {'measure': 'MoCA scores', 'timeFrame': 'Baseline', 'description': 'The Montreal Cognitive Assessment (MoCA)'}, {'measure': 'ACE-III scores', 'timeFrame': 'Baseline', 'description': "Addenbrooke's Cognitive Examination (ACE) score"}, {'measure': 'Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)', 'timeFrame': 'Baseline', 'description': 'Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.'}, {'measure': 'HRV (ms)', 'timeFrame': 'Baseline', 'description': 'Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.'}, {'measure': 'Plasma α-synuclein levels (ng/ml)', 'timeFrame': 'Baseline'}, {'measure': 'Vic', 'timeFrame': 'Baseline', 'description': 'The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.'}, {'measure': 'PAF (Hz)', 'timeFrame': 'Baseline', 'description': 'The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.'}, {'measure': 'Vic', 'timeFrame': '1 year after Baseline', 'description': 'The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['α-synucleinopathy']}, 'descriptionModule': {'briefSummary': 'α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy.', 'detailedDescription': "α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom, including Parkinson's disease (PD), multiple system atrophy (MSA) and dementia with lewy bodies (DLB). The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy. Datas will be accumulated retrospectively at research entry and prospectively during follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a clinical diagnosis of PD, DLB and MSA.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with a clinical diagnosis of primary α-synucleinopathy\n* Unrelated healthy controls\n\nExclusion Criteria:\n\n* Patients with secondary α-synucleinopathy that cannot be excluded.\n* Patients with other neurological disorders.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT05527067', 'briefTitle': 'A Registered Cohort Study on α-Synucleinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'A Registered Observational Cohort Study on α-Synucleinopathy', 'orgStudyIdInfo': {'id': 'Cohort-PDS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'α-synucleinopathy', 'description': 'Participants with clinical diagnosis of α-synucleinopathy.', 'interventionNames': ['Other: Data collection']}, {'label': 'Healthy controls', 'description': 'Healthy controls', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected', 'armGroupLabels': ['α-synucleinopathy']}, {'name': 'Data collection', 'type': 'OTHER', 'description': 'Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected', 'armGroupLabels': ['Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodong Pan', 'role': 'CONTACT', 'email': 'pxd77316@163.com', 'phone': '0591-86218341'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Xiaodong Pan', 'role': 'CONTACT', 'email': 'pxd77316@163.com', 'phone': '0591-86218341'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}