Pacific Health Research and Education Institute (PHREI) is currently conducting 2 Net-PD studies coordinated by the University of Rochester Clinical Coordination Center and the Statistical Coordinating Center at the University of Texas School of Public Health. A Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study of Creatine in Subjects with Treated Parkinson's Disease (PD) Long-term Study-1 (LS-1): PHREI is one of 50 centers conducting the Phase III LS-1 clinical trial. This application requests funding for the three final required years of the trial. Our goal is to complete the trial with no further drop outs or individuals who are lost to follow-up. Additionally, we aim to complete all case report forms in a timely fashion without errors. It is hoped that the results of this trial wil show that the creatine treated group has less progression compared to the placebo group as measured by the global statistical test. A Multicenter, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early PD (FS-ZONE): For this trial, PHREI is one of 43 sites. No additional funding is being requested for this study. Our overall aims are: 1)to complete all visit with maximum retention of subjects for the ongoing LS-1 clinical trial, in order to determine if creatine is more effective than placebo in slowing clinical decline in treated subjects with PD; 2)to successfully recruit six subjects and complete all visits for ongoing FS-ZONE clinical trial to determine whether it is futile to proceed with studying pioglitazone as a potential agent to slow progression of PD; and 3) to participate in analyses and manuscript preparation of the main outcomes for both LS-1 (global statistical test) and FS-Zone (change in total UPDRS) and secondary analyses evaluating the effects of creatine and pioglitazone on individual PD clinical measures and on safety and tolerability.

Public Health Relevance

Parkinson's disease (PD) is the second most common neurodegenerative disease affecting 1-3% of individuals aged > 65. While there are medications that manage the symptoms effectively for a time; there is no cure for PD and no proven strategy for slowing progression. Therefore; a major priority for this field is to identify interventions tht slow progression and this is the aim of the NET-PD studies. Disclaimer: Please note that the following critiques were prepared by the reviewers prior to the Study Section meeting and are provided in an essentially unedited form. While there is opportunity for the reviewers to update or revise their written evaluation; based upon the group's discussion; there is no guarantee that individual critiques have been updated subsequent to the discussion at the meeting. Therefore; the critiques may not fully reflect the final opinions of th individual reviewers at the close of group discussion or the final majority opinion of the group. Thus the Resume and Summary of Discussion is the final word on what the reviewers actually considered critical at the meeting.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10NS044448-13
Application #
8601756
Study Section
Special Emphasis Panel (ZNS1-SRB-B (34))
Program Officer
Moy, Claudia S
Project Start
2002-09-30
Project End
2014-11-30
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
13
Fiscal Year
2013
Total Cost
$6,940
Indirect Cost
$9,309
Name
Pacific Health Research/ Education Institute
Department
Type
DUNS #
004524547
City
Honolulu
State
HI
Country
United States
Zip Code
96819