Continuation of NET-PD Trials at the University of Michigan

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): Current pharmacotherapy for Parkinson's disease (PD) is palliative. There is no treatment proven unequivocally to arrest or slow progression of PD. The NINDS Exploratory Trials in Parkinson's Disease (NET-PD) consortium was initiated to conduct clinical research trials of promising agents that could slow the clinical progression of PD. The clinical investigators and staff at the University of Michigan Health System have been involved as a NET-PD site since the inception of NET-PD and have been active participants in all clinical trials conducted by the NET-PD group. Our site has an excellent subject recruitment and retention record. Our site is committed to the safe conduct of clinical trials and has several measures in place to ensure participant safety. We actively participated in the original FS-1 and FS-TOO futility studies. We then enrolled 37 subjects in the LS-1 creatine study and are currently conducting follow-up visits on 33 subjects (retention rate 89%). We are committed to retaining and following these 33 subjects through completion of the LS-1 trial. We are also in the process of enrolling subjects for the FS-ZONE study, which is investigating whether pioglitazone can slow down the clinical progression of PD and have enrolled 2 subjects to date. Additionally, we have strong ties with the Michigan Parkinson Foundation (MPF), the major lay organization for PD in Michigan and plan on implementing a new initiative to increase and retain minority enrollment. Based on our previous experience in NET-PD, our clinical research infrastructure, and connection with the local PD community, we at the University of Michigan believe that we are well-equipped to continue serving as a clinical center for the remaining NET-PD trials. We plan on continuing to cooperate with other NET-PD centers, including the Coordination and Statistical Centers towards the goal of completing the current trials (LS-1 and FS-ZONE).