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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-06

Study Completion Date

2027-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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PARKINSON DISEASE (Disorder)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's disease patients

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

Smartwatch and mobile application

Intervention Type DEVICE

Wearing a smartwatch and using a mobile application for one year

Interventions

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Smartwatch and mobile application

Wearing a smartwatch and using a mobile application for one year

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No