Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-05 @ 12:14 AM
Study NCT ID:
NCT07189468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
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': 'Polygenic risk score'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Classification performance of the Parkinson's disease (PD) progression prediction model", 'timeFrame': 'Between baseline and 12 months', 'description': "Classification performance of the model in predicting observed motor disease progression, defined as a binary outcome: the condition of a patient is classified as worsened if either the Movement Disorder Society Unified Parkinson's Disease (MDS-UPDRS) rating scale part III score in ON-state increases by more than 3 points (\\>3), or the Levodopa Equivalent Daily Dose (LEDD) increases by more than 10%."}], 'secondaryOutcomes': [{'measure': 'Usability of the mAI-Care app', 'timeFrame': '12 month visit', 'description': 'System Usability Scale score of end-users (PD patients)'}, {'measure': 'Usability of the mAI-Insights app', 'timeFrame': '12 month visit', 'description': 'System Usability Scale score of end-users (clinicians)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AI', 'Parkinson disease', 'smartwatch'], 'conditions': ['PARKINSON DISEASE (Disorder)']}, 'descriptionModule': {'briefSummary': "The study aims to provide initial PoC validation data of two AI models to predict disease progression and treatment side effects in PD patients using as input patients' demographic, clinical and genetic information, as well as digital biomarker measurements in daily living collected via a smartwatch and a mobile application."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's disease patients", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease diagnosis according to MDS criteria (Postuma et al., 2015)\n* Disease duration ranging from 5 to 10 years\n* Age 40-80\n* Patients in stages 2 and 3 of the Hoehn and Yahr (a functional disability scale) in the ON condition\n* The participant is using a compatible smartphone\n* Written informed consent\n\nExclusion Criteria:\n\n* Atypical Parkinsonian Syndrome\n* Second-line device-aided treatments\n* Patients with \\>4 daily doses of L-DOPA\n* Daily levodopa equivalent dose \\> 1500 mg\n* Ongoing hallucinations requiring short-term treatment adjustment\n* Inability to provide informed consent or participate in the study\n* Inability to use the smartwatch and/or the mAI-Care app - as judged by investigator\n* Lacking motivation to participate in study procedures - as judged by investigator\n* Under adult autonomy protection system, legal guardianship or incapacitation\n* Pregnant and breast-feeding women"}, 'identificationModule': {'nctId': 'NCT07189468', 'acronym': 'AI-PMP', 'briefTitle': "AI-based Progression and Medication Response Prediction Study in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': "AI-based Progression and Medication Response Prediction Study in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'RC31/25/0193'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease patients", 'description': "Parkinson's disease patients to be monitored via a smartwatch and a mobile application", 'interventionNames': ['Device: Smartwatch and mobile application']}], 'interventions': [{'name': 'Smartwatch and mobile application', 'type': 'DEVICE', 'description': 'Wearing a smartwatch and using a mobile application for one year', 'armGroupLabels': ["Parkinson's disease patients"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Margherita FABBRI, MD', 'role': 'CONTACT', 'email': 'fabbri.m@chu-toulouse.fr', 'phone': '0561776039', 'phoneExt': '+33'}, {'role': 'CONTACT', 'email': 'fabbri.m@chu-toulouse.fr'}, {'name': 'Margherita FABBRI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Dresden', 'country': 'Germany', 'contacts': [{'name': 'Björn Falkenburger, MD', 'role': 'CONTACT'}, {'name': 'Björn Falkenburger', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Monica Kurtis, MD', 'role': 'CONTACT'}, {'name': 'Monica Kurtis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Ruber Internacional', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Alastair J Noyce, MD', 'role': 'CONTACT'}, {'name': 'Alistair Noyce', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Mary University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Margherita FABBRI, MD', 'role': 'CONTACT', 'email': 'fabbri.m@chu-toulouse.fr', 'phone': '0561776039', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aristotle Univ. of Thessaloniki (Greece)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}