Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06812702
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2025-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parkinson's Disease Biomarker Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}], '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': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Optional skin biopsy will be collected paravertebrally at approximately the C8 level at baseline. This procedure is performed to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD. Follow up skin samples of consenting participants will be collected at the one-year follow-up.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 295}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-02', 'studyFirstSubmitDate': '2025-02-02', 'studyFirstSubmitQcDate': '2025-02-02', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Digital Biomarkers', 'timeFrame': '12 months', 'description': 'Changes in continuous sensor-based measurements derived from Roche PD MobileApplication, with active testing and passive monitoring in idiopathic RBD and clinical PD (1 month in Healthy Controls)'}], 'secondaryOutcomes': [{'measure': 'alpha-synuclein deposition in skin biopsy', 'timeFrame': '12 months', 'description': 'Frequency of pathological alpha-synuclein deposition in the skin biopsy assay in idiopathic RBD and clinical PD and HC (optional study procedure)'}, {'measure': 'Changes in sensor-based measurements and passive monitoring', 'timeFrame': '12 months', 'description': 'Relationship between changes in continuous sensor-based measurements derived from Roche PD Mobile Application active testing and passive monitoring over 12 months in idiopathic RBD, clinical PD and HC and changes in clinical assessments'}, {'measure': 'Correlation of sensor-based measurements and imaging outcomes', 'timeFrame': '12 months', 'description': 'For idiopathic RBD patients only, correlation between sensor-based measurements derived from Roche PD Mobile Application active testing and passive monitoring and changes in MRI and DaT-SPECT outcome measures.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease, Idiopathic', 'REM Sleep Behavior Disorder']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to determine whether data acquired from a remote monitoring approach can reliably identify and track motor symptoms in prodromal PD and clinical PD.\n\nThe study is a one-year longitudinal biomarker study recruiting idiopathic RBD patients, Parkinson's Disease patient and healthy controls. All participants receive a smartphone with the Roche PD Mobile Application, complete a number of active tests daily and their movements will be remotely monitored. Participants will undergo additional neurological exams and DaT-SPECT and MRI imaging in the study.\n\nA second objective of this study will be to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD, in the peripheral nerves of the skin."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male or female over age 40, ability to follow protocol', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria\n\nExclusion Criteria:\n\n* participation in interventional clinical study within 3 months of screening, moderate to severe depression in judgement of the investigator, any concomitant disease, condition or treatment which may interfer with the conduct of study (determined by investigator), additional group-specific exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06812702', 'acronym': 'PDBS', 'briefTitle': "Parkinson's Disease Biomarker Study", 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': "A Multi-site Longitudinal Cohort Study of Prodromal and Clinical Parkinson'sDisease", 'orgStudyIdInfo': {'id': 'PDBS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control', 'description': 'Above 40 years of age, sex matched with PD cohort. Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.', 'interventionNames': ['Other: Observational', 'Procedure: Skin Biopsy']}, {'label': 'RBD Patients', 'description': 'Polysomnographic confirmed RBD, age 50 years or older, male and female. RBD patients only will receive DaT-SPECT and MRI imaging at baseline and Week52 of the study. Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.', 'interventionNames': ['Other: Observational', 'Procedure: Skin Biopsy']}, {'label': 'PD patients', 'description': 'Patients with PD first diagnosed 2-6 years prior to enrolment, above 40 years of age, male and female. Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.', 'interventionNames': ['Other: Observational', 'Procedure: Skin Biopsy']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Observational', 'armGroupLabels': ['Healthy Control', 'PD patients', 'RBD Patients']}, {'name': 'Skin Biopsy', 'type': 'PROCEDURE', 'description': 'Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.', 'armGroupLabels': ['Healthy Control', 'PD patients', 'RBD Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Juana Ayala Castaneda', 'role': 'CONTACT', 'email': 'juana.ayala@ubc.ca', 'phone': '604 822 5293'}], 'facility': "Pacific Parkinson's Research Centre", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Martine Comeau', 'role': 'CONTACT', 'email': 'martine.comeau.chum@ssss.gouv.qc.ca', 'phone': '514-890-8000', 'phoneExt': '30153'}], 'facility': "Centre hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Romina Perrotti', 'role': 'CONTACT', 'email': 'romina.perrotti@mcgill.ca', 'phone': '(514) 398-2964'}], 'facility': 'The Neuro', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nisha Pulimood', 'role': 'CONTACT', 'email': 'nisha.pulimood@mcgill.ca', 'phone': '514-396-2401'}], 'facility': 'The Neuro', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nicolas Dupré, MD MSc (bis) FAAN', 'role': 'CONTACT', 'email': 'nicolas.dupre.med@ssss.gouv.qc.ca', 'phone': '418-525-4444', 'phoneExt': '61672'}], 'facility': 'Centre de recherche du CHU de Québec-Université Laval (CHUQ)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Nisha Pulimood, PhD', 'role': 'CONTACT', 'email': 'nisha.pulimood@mcgill.ca', 'phone': '+1 514-396-2401'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ronald Postuma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Ronald Postuma', 'investigatorAffiliation': 'McGill University'}}}}