CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trials space. Staff Writer Ron Rosenberg spoke with Ray Dorsey, M.D., David M. Levy Professor of Neurology and director of the Center for Human Experimental Therapeutics (CHET) at the University of Rochester Medical Center.

Q: How did you come to measure Parkinson’s by using smartphones to capture objective measurements of the disease?

A: One of the chief challenges in measur­ing these neurological diseases, including Parkinson’s disease, is that current measures are subjective, episodic and not very sensitive. This is a problem in Alzheimer’s and Parkinson’s disease where we don’t have the assays of brain function. We can’t measure a cholesterol level or CD-4 count. [But] Parkinson’s has external manifestations—slowness in movement—that we can observe with sensors, which we build into smartphones that can provide a new and potentially powerful way for measuring these symptoms.

The genius behind this is mathematician Dr. Max Little, in the U.K. at Aston University, who demonstrated about five years ago that systematical analysis of voice recordings could differentiate individuals with Parkinson’s disease from those without—and that led him to develop a primitive smartphone application that measured voice, gait and posture used with an accelerometer built into a smartphone. The speed of tapping [measured] slowness of move­ment, and we demonstrated with a small pilot study of 10 patients with Parkinson’s disease and 10 without the disease that we could—with a high degree of accuracy—differentiate those individuals with Parkinson’s from those without.

We think these measures that rely on sensors can be very powerful ways to getting objective, potentially sensitive frequency assessments of individuals. To give you a flavor, in the next small pilot study with 20 individuals, we gave them a smartphone [with the Parkinson mPower ap­plication]. We asked them to use the smartphone four times a day to do the test for a month and they did it three times a day for a month. From that small study we had 1,800 data points on how people were doing. Some of our current studies with the Parkinson mPower application have over 500,000 data points on a single individual. [Formally known as the mobile Parkinson obser­vatory for worldwide evidence-based research, the mPower app aims to help users track their symptoms using activities including a memory game, finger tapping, speaking and walking, and is able to collect data from wearable devices. It was developed under Apple’s ResearchKit.]

Q: Can you explain “passive monitoring of data” and its role in evaluating a person’s disease state?

A: Most of the tests we do are active. We ask them to say “ahh” and tap with their index and middle fingers on a screen. We ask them to walk 20 feet and turn around. We ask them to stand still for 30 seconds.

In addition to that, the activity we can do with them is to monitor an individual’s condition, independent of them having to do something. In the mPower app, we have two passive measures: one of activity and a second with a GPS. Imagine: Someone with limited mobility may have some stigma tied to their Parkinson’s disease or their tremor might be less willing to go outside to socialize than someone whose Parkinson’s is well-controlled or doesn’t have Parkinson’s disease.

Similarly, we know with Parkinson’s disease that activity improves the condition. People who do exercise do better than those that don’t. We also can passively measure people who are inactive, or periods of the day where they are inactive perhaps because their medication is not working well. Or we get a much better sense of how people are doing during the course of the day, rather than having to rely solely on three to four clinic visits of 20 minutes each over a period of a year.

Q: Explain how you are mea­suring disease and symptom severity in a new drug program to treat Parkinson’s disease. Can this technology be used to measure other neurodegenerative diseases?

A: Roche has publicly indicated that they are using an earlier version of an android application with Dr. Max Little to evaluate a drug in an early-stage clinical trial. One of the near-term opportunities for these research tools is to help determine whether a new drug device, generically speaking, is efficacious in early-stage development.

As you can imagine, in Parkinson’s disease, if you have a subjective measure where you are measuring how fast someone taps their fingers and we grade that from zero to four, that can be insensitive and take a long time to change and require a large number of participants. We are hoping these tools can give you a signal as to whether an intervention is efficacious in a shorter period of time, and with a smaller number of individuals.

We think they can be applied to a wide range of other neurodegenerative conditions, especially the ones with external manifestations like Huntington’s disease and Friedreich’s ataxia [an autosomal recessive, inherited disease that causes progressive damage to the nervous system].

This article was reprinted from Volume 19, Issue 46, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »