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DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization

CompletedN/A

Sponsor: Newel Health SRL

Conditions: Parkinson Disease

Interventions: Smartwatch Garmin Vivosmart [wearable sensor], Soturi™ [digital mobile app], Clinical Assessment

Countries: Italy

The study is aimed at developing Digital Therapeutics (DTx) algorithms for personalized PD treatment and medication plan optimization, based on Real World Data (RWD) collected from patients via digital mobile app and wearable sensors. The study design is observational/noninterventional, prospective, single-arm, aimed at collecting data from wearable sensors for validation of symptom detection algorithms, through (1) a supervised in-clinic motor assessment, performed using validated clinical scales (Visit 3, Visit 4), and (2) an unsupervised, home-based, 6-month (Visit 3 to Visit 4) data collection from wearable devices (passive monitoring) for algorithm cross-validation using patient reported outcomes (PROMs) and remote clinical assessments. The devices used in the study will be a commercial smartwatch (Garmin Vivosmart 5) for inertial data collection and a digital application through which subjects will report PROMs via a digital symptom diary. Screening visits (Visit 1 and Visit 2) will be conducted prior to enrollment to verify eligibility criteria through clinical assessments, the subjects' symptom diary, and by assessing adherence to the use of the study tools provided (i.e., mobile application and smartwatch).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Age \> 18 years.
3. Male or female patients Meeting the MDS clinical diagnostic criteria for Parkinson's Disease (Postuma et al., 2015)
4. At least one motor symptoms OFF-period each day, excluding early morning akinesia.
5. On treatment with Levodopa
6. Stable Levodopa regimen for 4 weeks before Screening Visit;
7. Levodopa Equivalent Daily Dose (LEDD) \> 400 mg, AND/OR Levodopa Intake \> 2 administration/day;
8. The subject is willing and able to attend study procedures and to use wearable and mobile devices.

Exclusion Criteria:

1. Secondary or atypical PD.
2. Cognitive problems which significantly impair his/her ability to give an IC and perform the study tasks.
3. Levodopa Equivalent Daily Dose (LEDD) \> 800 mg, AND/OR Levodopa intake \> 8 administration/day;
4. Any condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study.
5. Concomitant participation to clinical trials with investigational medicinal products.
6. Failure to show, in opinion of the investigator, acceptable/appropriate use of wearable and mobile device (e.g. weekly average daily wearable wear time \< 8 hours).

Having an advanced treatment (including Deep Brain Stimulation, Apomorphine, Duodopa), is not an exclusion criterion, as well as the subject decision or capability to attend the exercise and speech training programs within the mobile app.

Locations (3)

Salerno, Salerno, Italy
Roma, Italy
Roma, Italy