Making a spark, igniting a fire

NEW YORK, N.Y.—The Michael J. Fox Foundation (MJFF) and PaloAlto, Calif.-based Kinetics Foundation are partnering to search for a biomarkerto measure progression in Parkinson's disease by the use of an innovativecomputer-based device called the Objective Parkinson's Disease MeasurementSystem (OPDM).

The device, designed by the Kinetics Foundation, will betested in three clinical sites to evaluate how it might better measure specificmotor characteristics of Parkinson's.

A progression marker could be a game-changer for thedevelopment of next-generation Parkinson's treatments, especially adisease-modifying treatment, according to MJFF.

The joint venture is being added to MJFF's Parkinson'sProgression Markers Initiative (PPMI), a landmark, five-year clinical studyaiming to identify biomarkers of Parkinson's progression, one of MJFF's highestpriorities, says Ken Marek, PPMI's principal investigator and senior scientistat the Institute for Neurodegenerative Disorders in New Haven, Conn. This typeof marker is critically needed for the success of clinical trials, particularlythose searching for potential disease-modifying treatments.

"The primary goal of PPMI is to identify biomarkers thattrack Parkinson's disease progression," Marek says. "Currently, PPMI studysubjects are undergoing tests focused on clinical symptoms, brain imaging andbiological samples. The OPDM device will now provide an additional strategy tomeasure motor function and may be a simple and efficient way to measureParkinson's progression that can be used at home, rather than in the clinic."

While the Unified Parkinson's Disease Rating Scale isconsidered the gold standard for measuring Parkinson's progression, because itrelies on subjective clinical opinion, it is not truly quantitative, says RickBentley, spokesman for the Kinetics Foundation.

"The first visible sign of Parkinson's is a movementdisorder," Bentley says. "The device measures 'upper body bradykinesia,' whichis 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 thefinger-tapping and peg transfer exercises that gauge speed and reaction time,he says. By doing so, it is designed to objectively and more accurately measureParkinson's severity by detecting changes in motor function. This could shortenthe time needed to perform assessments in clinical trials.

The device comes with an instructional video, and theresults of the dexterity tests are stored on a memory stick, Bentley says. Thepatient puts the memory stick into a computer, and data is uploaded over theInternet to a central server that the researchers can access and thusinterpret.

If successful, the device could become a commercialventure—but not for Kinetics.

"We're the philanthropic foundation trying to make a sparkto ignite a fire," Bentley explains. "There are some private companies alreadytrying to do this. We are trying to help develop the space for them. To helpthe 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. Wehave built more than 100 of the devices, which are all committed to patients inclinical trials with the goal to use the device to quantify the results of thetreatments in each trial."

Todd Sherer, CEO of MJFF, stated, "Throughout the course ofour relationship with the Kinetics Foundation, we have worked together to bringinnovative research to the fore, collaborating on diverse projects includingneurotrophic therapies and improving brain drug delivery in Parkinson's. Thisis the latest project in a partnership that we hope will speed progress towardbetter 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 newParkinson's treatments and cures, their PPMI project may be their mostimportant effort to date."

"Finding a biomarker for Parkinson's might allow for earlierand more accurate diagnosis, as well as measurement of disease progression andtreatment efficacy," Kubota adds. "We are excited to be part of this valuablework."

This study will be offered at three PPMI sites: theUniversity of Pennsylvania in Philadelphia, the Institute for NeurodegenerativeDisorders in New Haven, Conn. and the Oregon Health & Science University inPortland, Ore. PPMI is recruiting newly diagnosed people with Parkinson's aswell as controls at 21 study sites throughout the United States and Europe.