Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-04-07 @ 2:34 PM
Study NCT ID:
NCT06501469
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Parkinsonian Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'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': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2030-03-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographics', 'timeFrame': 'At enrolment', 'description': 'Age, gender, education, origin, race'}, {'measure': 'Family history', 'timeFrame': 'At enrolment', 'description': "Family history of Parkinson's, dementia, tremor, other movement disorders, other neurological disorders"}, {'measure': 'Age', 'timeFrame': 'At enrolment', 'description': 'Age at onset in years'}, {'measure': 'Disease duration', 'timeFrame': 'At enrolment', 'description': 'Disease duration in years'}, {'measure': 'First motor symptom', 'timeFrame': 'At enrolment', 'description': 'First motor symptom time of onset'}, {'measure': 'First non-motor symptom', 'timeFrame': 'At enrolment', 'description': 'First non-motor symptom time of onset'}, {'measure': 'Side of onset', 'timeFrame': 'At enrolment', 'description': 'Side of onset of first motor symptom'}, {'measure': 'Staging', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Hoehn and Yahr stage (H\\&Y) stage (1-5, higher score indicate higher impairment)'}, {'measure': "Clinical scales - Unified Parkinson's disease rating scale (UPDRS)", 'timeFrame': 'At enrolment and every six months over 5 years', 'description': "Unified Parkinson's disease rating scale I-IV (UPDRS I-IV, 0-260; higher scores indicate higher impairment)"}, {'measure': 'Clinical scales for Progressive supranuclear palsy (PSP)', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Progressive supranuclear palsy rating scale (PSP-RS) (0-100; higher scores indicate higher impairment)'}, {'measure': 'Clinical scales for Multiple system atrophy (MSA)', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Unified Multiple system atrophy rating scale (UMSAPRS)(0-104; higher scores indicate higher impairment)'}, {'measure': 'Clinical scales for PSP short', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Progressive Supranuclear Palsy Clinical Deflicts Scale (PSP-CDS)(0-21; higher scores indicate higher impairment)'}, {'measure': 'Clinical scales for apathy', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Starkstein Apathy Scale (SAS) (0-56; higher scores indicate higher impairment)'}, {'measure': 'Clinical scale for autonomic dysfunction', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': "The Scale for Outcomes in Parkinson's disease for Autonomic symptoms - (0-100; higher scores indicate higher impairment)"}, {'measure': 'Clinical scale for cognition', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Montreal Cognitive Assessment (MOCA) (0-30, lower scores indicate higher impairment)'}, {'measure': 'Clinical scale for frontal dysfunction', 'timeFrame': 'At enrolment and every six months over 5 years', 'description': 'Frontal assessment battery (FAB) (0-18, lower scores indicate higher impairment)'}, {'measure': 'Imaging outcome measures - nuclear medicine investigations', 'timeFrame': 'At enrolment', 'description': '(meta-iodobenzylguanidine) MIBG-Scintigraphy heart'}, {'measure': 'Imaging outcome measures - Positron emission tomography (PET)', 'timeFrame': 'At enrolment', 'description': 'fluorodeoxyglucose (FDG) -PET brain'}, {'measure': 'Imaging outcome measures - Dopamine Transporters imaging (DaTScan)', 'timeFrame': 'At enrolment', 'description': 'MRI brain'}, {'measure': 'Imaging outcome measures - Magnetic resonance imaging (MRI)', 'timeFrame': 'At enrolment', 'description': 'MRI brain'}, {'measure': 'Blood samples analysis (DNA)', 'timeFrame': 'At enrolment', 'description': 'Whole exome sequencing - genetic testing'}, {'measure': 'Blood samples analysis (biomarkers, exosomes)', 'timeFrame': 'At enrolment and after 2 years', 'description': 'Peripheral blood mononuclear cell (PBMCs), peripheral blood mononuclear cells, exosomes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Progressive Supranuclear Palsy', 'Multiple System Atrophy', 'Atypical Parkinsonism', 'Parkinsonism', 'Biomarkers'], 'conditions': ['Parkinson Disease', 'Progressive Supranuclear Palsy', 'Multiple System Atrophy', 'Atypical Parkinsonism', 'Parkinsonism']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study to identify biomarkers in parkinson syndromes. Patients with parkinsonian syndromes at the early stages of disease will be recruited and will be followed up until their established clinical diagnosis or for at least 5 years. In this population, imaging and wet biomarkers as well as clinical data will b systematically collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "* patients with unclassified Parkinsonism and disease duration \\< 2 years\n* patients with suggestive, possible or probable progressive suprnanuclear palsy (PSP) and disease duration \\<2 years according to established clinical criteria\n* patients with possible, probable or clinically confirmed multiple system atrophy (MSA) and disease duration \\<2 years according to established clinical criteria\n* patients with parkinsonism (PD, MSA or PSP) and disease duration \\> 2 years according to established clinical criteria\n* patients with Parkinson's disease (PD) and disease duration \\< 2 years according to established clinical criteria\n* patients with Parkinson's disease (PD) and disease duration \\> 2 years according to established clinical criteria\n* healthy individuals without any neurological disease", 'healthyVolunteers': True, 'eligibilityCriteria': "IΙnclusion Criteria:\n\n* Written informed consent, including consent to monitoring\n* Patients with Parkinsonism and disease duration \\< 2 years\n* Patients with Parkinsonism and disease duration \\> 2 years\n* Healthy individuals without any neurological disease\n\nExclusion Criteria:\n\n* Drug-induced parkinsonism (eg, neuroleptics, lithium, valproic acid, metoclopramide).\n* Metabolic conditions related parkinsonism (eg, Wilson's disease, hypoparathyroidism).\n* Structural lesions on brain magnetic resonance imaging (MRI) that explain the symptoms, such as normal pressure hydrocephalus, moderate to severe chronic vascular encephalopathy, cerebral infarction, neoplasm\n* Other serious diseases that indicate a life expectancy of \\<5 years.\n* Active participation in other interventional clinical studies"}, 'identificationModule': {'nctId': 'NCT06501469', 'acronym': 'PROATYP', 'briefTitle': 'Biomarkers in Parkinsonian Syndromes', 'organization': {'class': 'OTHER', 'fullName': "Non-profit organization for scientific research in Parkinson's disease and related disorders"}, 'officialTitle': 'Prospective, Observational Study to Identify Biomarkers in Parkinsonian Syndromes', 'orgStudyIdInfo': {'id': '642'}}, 'contactsLocationsModule': {'locations': [{'zip': '15123', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Maria Stamelou, Prof Dr', 'role': 'CONTACT', 'email': 'mstamelou@hygeia.gr', 'phone': '+302106867000', 'phoneExt': '337'}], 'facility': "HYGEIA Hospital, Parkinson's disease and Movement Disorders Department", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Maria Stamelou, Prof Dr', 'role': 'CONTACT', 'email': 'mstamelou@hygeia.gr', 'phone': '+302106867303'}], 'overallOfficials': [{'name': 'Maria Stamelou, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HYGEIA Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Non-profit organization for scientific research in Parkinson's disease and related disorders", 'class': 'OTHER'}, 'collaborators': [{'name': 'Biomedical Research Foundation, Academy of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}