Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 6:43 PM
Study NCT ID:
NCT01249768
Status:
UNKNOWN
Last Update Posted:
2016-03-31
First Post:
2010-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson's Disease, Diagnostic Observations (PADDO)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, cerebrospinal fluids'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2010-11-26', 'studyFirstSubmitQcDate': '2010-11-26', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of correct diagnosis for each of the specified ancillary investigations', 'timeFrame': '36 months', 'description': 'Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism'}], 'secondaryOutcomes': [{'measure': 'Percentage of correct diagnosis for each of the specified ancillary investigations', 'timeFrame': '36 months', 'description': 'Percentage of correct diagnosis for each of the specified ancillary investigations(MRI, CSF analysis, and second opinion) to differentiate between the specific diagnosis (PD, MSA, PSP, CBD, LBD, VaP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prospective study', 'diagnostic accuracy', 'CSF', 'MRI'], 'conditions': ["Parkinson's Disease", 'Atypical Parkinsonism']}, 'referencesModule': {'references': [{'pmid': '29764386', 'type': 'DERIVED', 'citation': "van Rumund A, Aerts MB, Esselink RAJ, Meijer FJA, Verbeek MM, Bloem BR. Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism. BMC Neurol. 2018 May 16;18(1):69. doi: 10.1186/s12883-018-1072-x."}]}, 'descriptionModule': {'briefSummary': "Background:\n\nParkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. However, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. Ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma.\n\nObjective:\n\nTo investigate the value of ancillary diagnostic investigations, more specific MRI, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate Parkinson's disease and the Atypical Parkisonisonian disorder."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a hypokinetic-rigid syndrome with a disease duration of maximum 36 months and in whom a definitive diagnosis has not been established yet.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypokinetic rigid syndrome\n* Disease duration of maximum 36 months\n\nExclusion Criteria:\n\n* Probable diagnosis of PD without any red flags\n* Probable diagnosis MSA\n* Probable diagnosis PSP\n* Diagnosis CBD\n* Diagnosis DLB\n* Probable diagnosis Vascular Parkinsonism\n* Other neurodegenerative disease than parkinsonism\n* A prior history of brain surgery\n* Instable comorbidity'}, 'identificationModule': {'nctId': 'NCT01249768', 'acronym': 'PADDO', 'briefTitle': "Parkinson's Disease, Diagnostic Observations (PADDO)", 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "Observational Study Assessing the Diagnostic Contribution of 3-Tesla MRI, CSF Analysis and a Second Opinion in a Specialized Movement Disorder Centre, in Differentiating Between Parkinson's Disease and Atypical Parkinsonism", 'orgStudyIdInfo': {'id': 'PADDO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'The cohort will consist of 150 patients with a hypokinetic rigid syndrome and a disease duration of maximum 36 months'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Radboud University Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'B Bloem, Prof, MD', 'role': 'CONTACT', 'email': 'b.bloem@neuro.umcn.nl'}], 'overallOfficials': [{'name': 'M Verbeek, PhD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'B Bloem, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr. M.B. Aerts', 'investigatorFullName': 'Marjolein Aerts', 'investigatorAffiliation': 'Radboud University Medical Center'}}}}