DESCRIPTION (provided by applicant): The goal of this proposal is to participate as a clinical site in the nation-wide study of neuroprotection in Parkinson's disease (NET-PD). A number of pilot studies have been designed to test the potential neuroprotective agents as well as to verify study design and methodology. The results of the pilot studies will be used to select the agent for the pivotal study. As a clinical site, our primary objective will be to recruit and retain research subjects to participate in the proposed clinical trial. We plan to recruit at least 2 patients per month during the 30 months recruitment phase of the trial (60 patients). We propose partnership between two Parkinson's disease and Movement Disorders Center at Northwestern University; downtown campus and Evanston campus. Both campuses have an established patient base, highly trained personnel, and extensive experience in design and conduct of multicenter clinical trials in PD. Both campuses have a track record of successful recruitment and retention of research participants at all stages of PD. We also will have access to PD patient population at the Jesse Brown VA Center to enhance the enrollment and diversity of the study population. We are willing to cooperate with the other centers in conduct of one or more clinical trials. We also are prepared to have additional responsibilities that might include: collaboration with the coordinating center and biostatistical center, participation in the cooperative design of the study protocols and operations manuals, cooperation with data audits and study monitors, agreement to publish data collected at our site only in accordance with the guidelines established by the study publications committee, to take all appropriate measures to protect human subjects and to ensure adequate representation of genders and racial and ethnic minorities in the study.
|Effective start/end date||5/17/06 → 11/30/12|
- National Institute of Neurological Disorders and Stroke (5 U10 NS053377-02)