NCT07189468

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Oct 2025

Geographic Reach
4 countries

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Oct 2025Apr 2027

First Submitted

Initial submission to the registry

September 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

September 16, 2025

Last Update Submit

September 16, 2025

Conditions

PARKINSON DISEASE (Disorder)

Keywords

AIParkinson diseasesmartwatch

Outcome Measures

Primary Outcomes (1)

  • Classification performance of the Parkinson's disease (PD) progression prediction model

    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%.

    Between baseline and 12 months

Secondary Outcomes (2)

  • Usability of the mAI-Care app

    12 month visit

  • Usability of the mAI-Insights app

    12 month visit

Study Arms (1)

Parkinson's disease patients

Parkinson's disease patients to be monitored via a smartwatch and a mobile application

Device: Smartwatch and mobile application

Interventions

Smartwatch and mobile applicationDEVICE

Wearing a smartwatch and using a mobile application for one year

Parkinson's disease patients

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's disease patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital of Toulouse

Toulouse, France

Location

Technische Universität Dresden

Dresden, Germany

Location

Hospital Ruber Internacional

Madrid, Spain

Location

Queen Mary University of London

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Polygenic risk score

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Margherita FABBRI, MD

CONTACT

0561776039fabbri.m@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 24, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)FR(1)GB(1)DE(1)