Clinical Center for the Parkinson Disease Neuroprotection Clinical Trial

Friedman, Joseph

Abstract

The goal of this proposal is to participate as a clinical site in exploratory trials of neuroprotective agentsfor patients with early Parkinson's disease (PD). Current therapies for PD address the symptoms, but do notalter the course of the disease. However, a number of new compounds have been identified that have thepotential to slow down or even halt the progression of PD. If any of these compounds can truly protect viableneurons from degenerating, they would delay or even prevent significant disability in the millions of patientswho suffer from PD. Our primary objective with this project will be to recruit and retain at least 2 research subjects per monthFor the remaining exploratory neuroprotection trials, and the subsequent large simple trial. The Parkinson'sDisease and Movement Disorders Center (PDMDC) at Memorial Hospital of Rhode Island (MHRI) employs astaff of highly qualified investigators and coordinators with extensive experience (over 35 years in total) inthe design and conduct of clinical trials in PD. Our center has consistently recruited PD patients for researchstudies over many years. We recruit particularly well for the early PD clinical trials, meeting or exceedingexpected quotas in each trial needing de novo, untreated PD patients. We are the only movement disorderscenter in the state of Rhode Island, and see patients from all over Rhode Island and southeastern NewEngland. Our patients do not like to travel far for their medical care, and are unlikely to go to other largemovement disorders centers. They are extremely compliant with study protocols, and have a strong interestin participating in clinical studies. We have strong ties with the American Parkinson Disease Association (APDA) Rhode Island Chapter,which is the largest PD advocacy group in the region. The APDA chapter is extremely active and supportiveof our endeavors, and the APDA's information and Referral (I&R) Center is an intrinsic part of the PDMDC.The I&R Center is responsible for regional education and support, including coordination of support groups.Rhode Island is also home to a large Hispanic and female population, making it relatively easy for us torecruit minorities and women into the study. Because of our track record in recruiting for similar trials, ourclose connections with local advocacygroups, and our referral population (comprised of a large group ofethnic minorities and women), we believe that we are qualified to serve as a clinical center for the PDneuroprotection trials.