Roche Pharma Research & Early Development (pRED) has developed a smartphone-based monitoring system for those with Parkinson’s disease (PD) that complements the traditional physician-led assessments with automated tests that continuously measure their symptom fluctuations. It could be the first time that such an app has been used to measure disease and symptom severity in a medicine development program in PD.
“The app is being used in a phase I trial run by Prothena, in collaboration with Roche in PD. In clinical trials in this area, disease disability and impairment are traditionally measured by physician assessments using the Unified Parkinson’s Disease Rating Scale (UPDRS). However, these are limited to the specific times that patients go for an appointment with their physicians. The app will enable continuous measurement of PD fluctuation every day and throughout the day. Ultimately, we hope the app can be used in future clinical development to enable more objective measures on response to treatment to complement doctor assessments,” said Anirvan Ghosh, head of Neuroscience Discovery for pRED.
Patients will be asked to follow a daily routine with the app, using it every day for the duration of the trial. The routine will consist of six active tests followed by passive monitoring. These assessments are designed to provide information on a person's symptoms, their progress and impact on daily life. The app has been developed in consultation with Max Little, a PD app developer best known for his work on the Parkinson’s Voice Initiative. Max is assistant professor at Aston University and is associated with Oxford University and the MIT Media Lab. The project also has been presented to the Michael J. Fox Foundation for Parkinson’s Research.
The active tests will ask patients to do a series of 30-second long activities. These include:
Voice test (conducting an “aaah” sound for as long as possible);
Balance test (standing still);
Gait test (walking 20 yards, including an 180-degree turn);
Dexterity test: tapping two buttons alternately on the touchscreen with the dominant-use hand;
Rest tremor test (holding the smartphone in the hand most affected by the tremor, resting it on the lap and counting back from 100); and
Postural tremor test (holding the smartphone in the same hand, outstretched).
For passive monitoring, patients are asked to carry the smartphone with them throughout the day. Data is then collected from the various smartphone sensors. Patients will be asked to use the app for the duration of the trial, including screening, dosing and follow-up, which may last up to a period of about 32 weeks.
The app is equipped with dashboards that show the patient’s compliance level. Based on that information, investigators can guide patients to use the app more regularly. Additionally, clinicians can monitor how much data is coming in from the smartphones.
The app has been developed for Android and it has been deployed to the trial on a Samsung Galaxy S3 Mini. Roche provides patients with dedicated, preconfigured smartphones for the sole purpose of remote patient monitoring via the app. That provision makes the device and the app easier to use for the elderly patient population.
