Clinical trial NCT05904288: DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
Official title: Development of Digital Therapeutics Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Newel Health SRL
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Mediolanum Cardio Research
First posted: 2023-06-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study targets individuals diagnosed with idiopathic PD which experience wearing-off phenomena.

Brief summary: 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 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, 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, 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.

Primary outcomes:
measure: Change in MDS-UPDRS Part III score from baseline to the 6-month follow-up visit, as measured during in-clinic visits.
timeFrame: Baseline to Week 26
measure: Performance of the machine learning algorithm in predicting MDS-UPDRS Part III scores based on accelerometer data collected during in-clinic visits and home-based unsupervised data collected over 6 months.
timeFrame: Baseline to Week 26
measure: Change in patient-reported motor symptoms, as measured by an electronic symptoms diary, from baseline to the 6-month follow-up visit.
timeFrame: Baseline to Week 26
measure: Performance of the machine learning algorithm in predicting patient-reported symptom scores based on accelerometer data collected during in-clinic visits and home-based unsupervised data collected over 6 months
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change in MDS-UPDRS Total Score and sub-scale total scores (Parts I-II-IV)
timeFrame: Baseline to Week 26
measure: Change in PDQ-39 Total Score
timeFrame: Baseline to Week 26
measure: Change in Levodopa and Dopamine-Agonist Equivalent Daily Dosages (LEDD, DAEDD)
timeFrame: Baseline to Week 26
measure: Change in Levodopa Medication Plan: Medication Dose Strength
timeFrame: Baseline to Week 26
measure: Change in Levodopa Medication Plan: Units
timeFrame: Baseline to Week 26
measure: Change in Medication Levodopa Plan: Frequency of Intakes
timeFrame: Baseline to Week 26
measure: Change in Motor Symptoms Digital Biomarkers: duration
timeFrame: Baseline to Week 26
measure: Change in Motor Symptoms Digital Biomarkers: frequency
timeFrame: Baseline to Week 26
measure: Change in Motor Symptoms Digital Biomarkers: severity
timeFrame: Baseline to Week 26
measure: Digital Biomarkers: Activity
timeFrame: Baseline to Week 26
measure: Change in ePROMs: symptoms frequency
timeFrame: Baseline to Week 26
measure: Change in ePROMs: symptoms severity
timeFrame: Baseline to Week 26
measure: Change in ePROMs, reported symptoms duration
timeFrame: Baseline to Week 26
Other outcomes:
measure: Usability of Soturi mobile app: System Usability Scale (SUS)
timeFrame: Baseline to Week 26
measure: Usability of Soturi Mobile App: Session Duration
timeFrame: Baseline to Week 26
measure: Usability of Soturi Mobile App: Frequency of App Interactions"
timeFrame: Baseline to Week 26
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele
city: Roma
country: Italy
facility: IRCCS Fondazione Santa Lucia
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Study officials:
References: