Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression (PPMI)
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes.
The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||The Parkinson's Progression Markers Initiative (PPMI)|
- The mean rates of change and the variability around the mean of clinical, imaging and biomic outcomes in early PD patients, and where appropriate the comparison of these rates between PD patient subsets and between PD and healthy subjects. [ Time Frame: Study intervals from 3 months - 36 months ] [ Designated as safety issue: No ]Specific examples of outcomes include MDS-UPDRS, DAT striatal uptake, and serum and CSF alpha-synuclein. PD patient subsets may be defined by baseline assessments, progression milestones and/or rate of clinical, imaging, or biomic change.
- Correlations between the rates of change in the mean of clinical, imaging and biomic outcomes in early PD patient subsets and between PD and healthy subjects. Expand the safety database of 18F-AV-133 Positron Emission Tomography (PET) Imaging. [ Time Frame: Study Intervals from 3 months to 36 months ] [ Designated as safety issue: No ]
- Prevalence of measures of clinical, imaging and biomic outcomes in early PD patients and healthy subjects. [ Time Frame: from baseline to 36 months. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
PPMI will be a five-year natural history study (a minimum of 3-year involvement for each subject) of de novo idiopathic PD patients and healthy controls. This study will also include a SWEDD population (subjects without evidence of dopaminergic deficit).
All subjects will be comprehensively assessed at baseline and every three to six months thereafter. Subjects will undergo clinical (motor, neuropsychiatric and cognitive) and imaging assessments and will donate blood, urine, and cerebral spinal fluid (CSF). A blood sample for DNA will be collected. Data will be collected by each site under uniformly established protocols and data will be analyzed and stored at designated core facilities.
Show 24 Study Locations
|Study Chair:||Kenneth L Marek, MD||Institute for Neurodegenerative Disorders|
|Principal Investigator:||John Q. Trojanowski, MD, PhD||University of Pennsylvania|
|Principal Investigator:||Arthur W. Toga, PhD||University of California, Los Angeles|
|Principal Investigator:||Alison Ansbach, MS||Coriell Institute for Medical Research|
|Principal Investigator:||Karl Kieburtz, MD||Clinical Trials Coordination Center|
|Principal Investigator:||Andrew Singleton, PhD||Laboratory of Neurogenetics; National Institute on Aging NIH|
|Principal Investigator:||John P Seibyl, MD||Institute for Neurodegenerative Disorders|
|Principal Investigator:||Christopher Coffey, PhD||Clinical Trials Statistical and Data Management Center, University of Iowa|