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Development of digital therapeutics algorithms for personalized Parkinson's disease treatment and medication plan optimization

NCT ID NCT05904288

NEW Sponsor: Newel Health SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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).

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Study facts

What this study's own registry entry says, in plain language.

Participants

54 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study targets individuals diagnosed with idiopathic PD which experience wearing-off phenomena.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

    Salerno, Salerno, 84100, Italy

  • IRCCS Fondazione Santa Lucia

    Roma, 00179, Italy

  • IRCCS San Raffaele

    Roma, 00163, Italy

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