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).

Public Health Relevance

PD is a slowly progressive, neurodegenerative disorder that causes significant disability and decreased quality of life. Unfortunately, no current therapies or treatment strategies have been proven to slow clinical decline in PD. By taking part in the NET-PD consortium, we will determine if medications such as creatine (LS-1) or pioglitazone (FS-ZONE) can truly slow down the clinical progression of PD. If so, then it will revolutionize the way we treat PD, ultimately resulting in less disability and increased quality of life.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10NS044504-11
Application #
8459176
Study Section
Special Emphasis Panel (ZNS1-SRB-B (34))
Program Officer
Moy, Claudia S
Project Start
2002-09-30
Project End
2015-11-30
Budget Start
2013-01-01
Budget End
2013-11-30
Support Year
11
Fiscal Year
2013
Total Cost
$73,569
Indirect Cost
$26,258
Name
University of Michigan Ann Arbor
Department
Neurology
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Coleman, Robert R; Kotagal, Vikas; Patil, Parag G et al. (2014) Validity and Efficacy of Screening Algorithms for Assessing Deep Brain Stimulation Candidacy in Parkinson Disease. Mov Disord Clin Pract 1:342-347
Chou, Kelvin L; Lenhart, Adrienne; Koeppe, Robert A et al. (2014) Abnormal MoCA and normal range MMSE scores in Parkinson disease without dementia: cognitive and neurochemical correlates. Parkinsonism Relat Disord 20:1076-80
Soileau, Michael J; Persad, Carol; Taylor, Jennifer et al. (2014) Caregiver burden in patients with Parkinson disease undergoing deep brain stimulation: an exploratory analysis. J Parkinsons Dis 4:517-21
Armstrong, Melissa J; Duff-Canning, Sarah; Tang-Wai, David F et al. (2013) The meaning of a "hippo" response on the Montreal Cognitive Assessment in Parkinson's disease. Parkinsonism Relat Disord 19:463-5
Uc, E Y; McDermott, M P; Marder, K S et al. (2009) Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort. Neurology 73:1469-77