Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 9:09 PM
Study NCT ID:
NCT05065060
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson Progression Marker Initiative Online (PPMI Online)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2041-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2041-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale Ib & II", 'timeFrame': 'Baseline to 240 months', 'description': "Evaluates self-reported motor and nonmotor Parkinson's disease symptoms"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson', 'Neurodegenerative Disorder', 'Prodromal', 'At Risk', 'Participant Reported Outcomes'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '41034300', 'type': 'DERIVED', 'citation': "Pierz KA, Aamodt W, Gochanour C, Kurth R, Brumm MC, Coffey CS, Heathers LE, Totten M, Doty RL, Marek K, Siderowf A; Parkinson's Progression Markers Initiative. Percentile scores for the revised University of Pennsylvania Smell Identification Test for 16,972 individuals 60 years of age and older. NPJ Parkinsons Dis. 2025 Oct 1;11(1):280. doi: 10.1038/s41531-025-01095-9."}]}, 'descriptionModule': {'briefSummary': "Parkinson Progression Marker Initiative Online (PPMI Online) is an observational study collecting participant reported information from people with and without Parkinson's disease (PD), for the goal of better understanding risk and predictive factors for PD.\n\nPPMI Online is part of the broader Parkinson Progression Marker Initiative aimed at identifying markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.", 'detailedDescription': 'PPMI is a broad program that is expanding the goals of the original PPMI study, and will include this PPMI Online protocol, as well the PPMI Clinical \\[NCT04477785\\], PPMI Remote, PPMI Digital protocols (with external regulatory oversight). All participants in PPMI may be asked to participate in one or all of these protocols and their enrollment in these studies may occur in varying order. PPMI participants may also be asked to participate in additional PPMI companion studies (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In PPMI Online, up to 500,000 participants with and without PD will be enrolled and contribute data longitudinally and cross-sectionally using a web-based platform.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson Disease (PD) Participants:\n\n * Male or female age 18 years or older.\n * Has received a diagnosis of Parkinson's disease\n\nParticipants without PD:\n\n* Male or female age 18 years or older.\n* Has not received a diagnosis of Parkinson's disease"}, 'identificationModule': {'nctId': 'NCT05065060', 'briefTitle': 'Parkinson Progression Marker Initiative Online (PPMI Online)', 'organization': {'class': 'OTHER', 'fullName': "Michael J. Fox Foundation for Parkinson's Research"}, 'officialTitle': "Parkinson's Progression Markers Initiative Online Study (PPMI Online)", 'orgStudyIdInfo': {'id': 'PPMI-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Observation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'UCSF', 'role': 'CONTACT', 'phone': '877-525-7764'}], 'facility': 'UCSF Movement Disorders and Neuromodulation Center (MDNC)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'University of California, San Francisco', 'role': 'CONTACT', 'email': 'info@ppmionline.org', 'phone': '877-525-7764'}], 'overallOfficials': [{'name': 'Caroline Tanner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Kenneth L Marek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Neurodegenerative Disorders'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Protocol Co- Principal Investigator', 'investigatorFullName': 'Caroline M Tanner', 'investigatorAffiliation': 'University of California, San Francisco'}}}}