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AI-based Progression and Medication Response Prediction Study in Parkinson's Disease | Clinical Trials | Clareo Health

NOT_YET_RECRUITING

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

NCT07189468•University Hospital, Toulouse

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 genetic information, as well as digital biomarker measurements in daily living collected via a smartwatch and a mobile application.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (4)

University Hospital of Toulouse

Toulouse, France

Technische Universität Dresden

Dresden, Germany

Hospital Ruber Internacional

Madrid, Spain

Queen Mary University of London

London, United Kingdom

Key Dates

Start Date

October 6, 2025

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2027

Last Updated

September 24, 2025

Enrollment

100

ESTIMATED participants

Conditions

PARKINSON DISEASE (Disorder)

Interventions

Smartwatch and mobile application

DEVICE

Contacts

Margherita FABBRI, MD

CONTACT

0561776039 fabbri.m@chu-toulouse.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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