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IOWA CITY - Two years after a small clinical trial revealed potential game-changing findings for sufferers of Parkinson's disease, the Michael J. Fox Foundation on Monday launched a larger follow-up study involving - among other institutions - the University of Iowa.
The question the study seeks to answer is whether a drug approved to treat cancer can be repurposed for Parkinson's patients, potentially slowing the disease's progression or even reversing its effects.
The initial 2015 Georgetown University trial found 'spectacular” indications it could, as mental processing improved among the 12 patients involved.
Georgetown is following up with a second-phase study as is the Michael J. Fox Foundation, which Monday began enrolling Parkinson's patients to test the safety and tolerability of Nilotinib - approved by the U.S. Food and Drug Administration in 2007 to treat a type of leukemia.
The first part of the study hopes to enroll 75 people with moderate to advanced Parkinson's at up to 25 clinical sites across the country. The UI College of Public Health's Clinical Trials Statistical Data Management Center will collect and analyze data for the trial and its lead researchers - serving as the study's biostatistics coordinating center.
Chris Coffey, director of the UI center, has been involved in the trial's planning for about a year. This newest collaboration adds to a growing list of Fox Foundation projects on which the UI center has been working - a partnership that began in 2009.
Of the center's $4 to $5 million annually in external research funding, about a third comes from the Fox Foundation.
Other projects for which the UI center has provided data assistance or statistical analysis include a landmark Parkinson's Progression Marker's Initiative aimed at identifying biomarkers of the disease's progression and developing a comprehensive Parkinson's database and biorepository.
The UI center also is involved in a newer initiative called Fox Insight, which television star and Parkinson's patient and activist Michael J. Fox recently talked about on 'CBS Sunday Morning.”
That project is a crowd-sourcing-style study in which Parkinson's patients and their loved ones can register online to share information about their symptoms and treatments.
'Because we do a lot of database development here, we have been involved in that - particularly a couple people from our group here - in making sure that as they set this up, that it's set up in a way that you're getting data that is usable,” Coffey said.
As for the study, Coffey said, his center expects to begin processing data soon since the test groups will be phased in and the first could begin quickly. The goal is to track the enlistees' use of the repurposed drug over six months.
The first cohort's 75 participants will be broken into three groups - 25 will take a placebo, 25 will take a lower dose and 25 will take a higher dose, according to Coffey.
Because the drug comes with a significant lineup of possible side effects - including cardiac problems and even death - the hope is to determine its safety and tolerability among a more vulnerable Parkinson's population first.
Findings then will inform a second cohort of participants who would be in earlier stages of Parkinson's.
Parkinson's is a neurological disorder that causes involuntary motions and tremors and can affect speech and balance. According to the Fox Foundation, a million people in the United States may have it.
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