Status:
NOT_YET_RECRUITING
AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Aristotle Univ. of Thessaloniki (Greece)
Conditions:
PARKINSON DISEASE (Disorder)
Eligibility:
All Genders
40-80 years
Brief Summary
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 genet...
Eligibility Criteria
Inclusion
- Parkinson's disease diagnosis according to MDS criteria (Postuma et al., 2015)
- Disease duration ranging from 5 to 10 years
- Age 40-80
- Patients in stages 2 and 3 of the Hoehn and Yahr (a functional disability scale) in the ON condition
- The participant is using a compatible smartphone
- Written informed consent
Exclusion
- Atypical Parkinsonian Syndrome
- Second-line device-aided treatments
- Patients with \>4 daily doses of L-DOPA
- Daily levodopa equivalent dose \> 1500 mg
- Ongoing hallucinations requiring short-term treatment adjustment
- Inability to provide informed consent or participate in the study
- Inability to use the smartwatch and/or the mAI-Care app - as judged by investigator
- Lacking motivation to participate in study procedures - as judged by investigator
- Under adult autonomy protection system, legal guardianship or incapacitation
- Pregnant and breast-feeding women
Key Trial Info
Start Date :
October 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07189468
Start Date
October 6 2025
End Date
April 1 2027
Last Update
September 24 2025
Active Locations (4)
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1
University Hospital of Toulouse
Toulouse, France
2
Technische Universität Dresden
Dresden, Germany
3
Hospital Ruber Internacional
Madrid, Spain
4
Queen Mary University of London
London, United Kingdom