Cynapsus and the Michael J. Fox Foundation (MJFF) are partnering to incorporate a wearable device into a phase III study of patients with Parkinson’s disease. Similar to a smartwatch, the device is equipped with motion sensors to detect when patients have an “OFF” episode—a period where medicine stops working and motor impairment symptoms return. The symptoms include muscle stiffness or problems with starting movements, such as starting to walk or getting out of a chair.

The device will be used in a phase III study of Cynapsus’ APL-130277, an under-the-tongue formulation of apomorphine that is fast-acting and easy to administer.  The drug is specifically designed to treat “OFF” episodes in patients with Parkinson’s.

The project builds on MJFF’s collaboration with Intel in 2014, which developed platforms to store patient-generated data and algorithms to interpret results. The smartwatch will be paired with a smartphone app to collect the data, which will then be de-identified, analyzed using advanced analytics and stored in a cloud platform. Researchers intend to use the data to learn more about Parkinson’s disease, “OFF” episodes and the efficacy of APL-130277.

With such a vast amount of data being gathered, it would be unrealistic to expect usable results next year, explains James Beck, Ph.D., vice president of scientific affairs at the Parkinson’s Disease Foundation. Once the data is collected, the difficult process of sorting, organizing and analyzing it will begin.

 “This is not about short-term benefits, but about long-term. People with Parkinson’s disease take their medication so they can move. But this population has a problem with medication suddenly wearing off, causing them to ‘freeze.’ This ‘freezing’ is so uncomfortable and such a pervasive issue that it keeps them from leaving their homes,” Beck said. “This technology will allow researchers to see if they can use the data to identify a pattern and predict the ‘OFF’ periods. Hats off to the Michael J. Fox Foundation, because the long-term prospects have a lot of potential.”

Another benefit from continuous data monitoring is that patients can be reluctant to keep a journal, and even those who do would not be able to relay all the detailed data transmitted by a wearable device.

Scott Ballenger, founder and CEO of Trial Acceleration Institute, said, “Emerging wearables and bio-sensors provide vast possibilities for clinical trial data collection. The rate-limiting factor is likely to be regulatory validation and acceptance of both new data endpoints and data capture methods.”

Indeed, Cami Gearhart, CEO of Quorum Review IRB, identified several potential IRB issues, including security of both the wearable device and data transfers in the cloud. She said, “We also consider the possibility that the device or smartphone could collect collateral information unrelated to the clinical trial, as a smartphone can provide access to extensive personal information such as geographic location, personal contacts, web searches and more.”

Furthermore, Gearhart notes that the population reached will be limited to a subset of Parkinson’s patients who have adequate motor functions to use the app, have access to a smartphone and understand how to use the smartphone app, which could disqualify a number of vulnerable populations from the trial. “However,” Gearhart said, “none of these issues are insurmountable, and they could be addressed in the study design and consent form disclosures.”

Another trial involving wearable devices for Parkinson’s patients was announced by UCB in December. The trial features a wearable patch associated with an app that monitors and records patients’ symptoms.

Parkinson’s disease is not the only therapeutic area that could be helped by the smartwatch and app used in the Cynapsus study. As Ballenger pointed out, “Mobility is such a key part of quality-of-life, and capturing additional, patient-generated data on condition-specific mobility could apply to many therapeutic areas.”

Gearhart agrees, saying, “Conceivably, wearable devices could be used for tracking a variety of physical attributes, and as technology evolves we expect to see more and more uses for these devices in clinical trials.”

Noting that wearable sensors have been used to detect epilepsy seizures for years, Beck sees the potential for wearables that are sensitive to heart rate and oxygen consumption, and also thinks they might be useful for arthritis and for neurodegenerative disorders such as Alzheimer’s disease and MS.

“This is a fishing expedition, to record an enormous amount of data and then sift it,” Beck explains. “We’re at the start of a journey, just starting down the road to see what wearables can do.” 

Lisa Chontos is a freelance medical writer with 15 years of experience writing for hospitals, biotech firms, pharmaceutical companies and publications like CenterWatch. You can contact her at lisa@lisachontos.com.

This article was reprinted from Volume 20, Issue 02, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »