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NCT07189468Not yet recruiting

AI-based Progression and Medication Response Prediction Study in Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
16 Sept 2025
Start date
6 Oct 2025
Primary completion date
1 Apr 2027
Lead sponsor
University Hospital, Toulouse
NCT number
NCT07189468

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 6 Oct 2025 to the primary completion date, 1 Apr 2027
  • 4 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Atypical Parkinsonian Syndrome

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Technische Universität Dresden
Coordinator of this site? Confirm its status
DresdenGermanyUnknown status
Hospital Ruber Internacional
Coordinator of this site? Confirm its status
MadridSpainUnknown status
University Hospital of Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Queen Mary University of London
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.