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Making a spark, igniting a fire
NEW YORK, N.Y.—The Michael J. Fox Foundation (MJFF) and Palo Alto, Calif.-based Kinetics Foundation are partnering to search for a biomarker to measure progression in Parkinson's disease by the use of an innovative computer-based device called the Objective Parkinson's Disease Measurement System (OPDM).
The device, designed by the Kinetics Foundation, will be tested in three clinical sites to evaluate how it might better measure specific motor characteristics of Parkinson's.
A progression marker could be a game-changer for the development of next-generation Parkinson's treatments, especially a disease-modifying treatment, according to MJFF.
The joint venture is being added to MJFF's Parkinson's Progression Markers Initiative (PPMI), a landmark, five-year clinical study aiming to identify biomarkers of Parkinson's progression, one of MJFF's highest priorities, says Ken Marek, PPMI's principal investigator and senior scientist at the Institute for Neurodegenerative Disorders in New Haven, Conn. This type of marker is critically needed for the success of clinical trials, particularly those searching for potential disease-modifying treatments.
"The primary goal of PPMI is to identify biomarkers that track Parkinson's disease progression," Marek says. "Currently, PPMI study subjects are undergoing tests focused on clinical symptoms, brain imaging and biological samples. The OPDM device will now provide an additional strategy to measure motor function and may be a simple and efficient way to measure Parkinson's progression that can be used at home, rather than in the clinic."
While the Unified Parkinson's Disease Rating Scale is considered the gold standard for measuring Parkinson's progression, because it relies on subjective clinical opinion, it is not truly quantitative, says Rick Bentley, spokesman for the Kinetics Foundation.
"The first visible sign of Parkinson's is a movement disorder," Bentley says. "The device measures 'upper body bradykinesia,' which is basically how fast you can move your fingers and arm. There are two tests, finger paddles (middle and index) and peg board."
The OPDM device actually tests dexterity through the finger-tapping and peg transfer exercises that gauge speed and reaction time, he says. By doing so, it is designed to objectively and more accurately measure Parkinson's severity by detecting changes in motor function. This could shorten the time needed to perform assessments in clinical trials.
The device comes with an instructional video, and the results of the dexterity tests are stored on a memory stick, Bentley says. The patient puts the memory stick into a computer, and data is uploaded over the Internet to a central server that the researchers can access and thus interpret.
If successful, the device could become a commercial venture—but not for Kinetics.
"We're the philanthropic foundation trying to make a spark to ignite a fire," Bentley explains. "There are some private companies already trying to do this. We are trying to help develop the space for them. To help the space, we have been going after the unprofitable market slice of clinical trials, which require a whole lot of support and usually don't use many devices. We have built more than 100 of the devices, which are all committed to patients in clinical trials with the goal to use the device to quantify the results of the treatments in each trial."
Todd Sherer, CEO of MJFF, stated, "Throughout the course of our relationship with the Kinetics Foundation, we have worked together to bring innovative research to the fore, collaborating on diverse projects including neurotrophic therapies and improving brain drug delivery in Parkinson's. This is the latest project in a partnership that we hope will speed progress toward better treatments for Parkinson's."
Ken Kubota, program director of the Kinetics Foundation, notes that while MJFF has "been a leading force in the search for new Parkinson's treatments and cures, their PPMI project may be their most important effort to date."
"Finding a biomarker for Parkinson's might allow for earlier and more accurate diagnosis, as well as measurement of disease progression and treatment efficacy," Kubota adds. "We are excited to be part of this valuable work."
This study will be offered at three PPMI sites: the University of Pennsylvania in Philadelphia, the Institute for Neurodegenerative Disorders in New Haven, Conn. and the Oregon Health & Science University in Portland, Ore. PPMI is recruiting newly diagnosed people with Parkinson's as well as controls at 21 study sites throughout the United States and Europe.