Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression (PPMI)
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|ClinicalTrials.gov Identifier: NCT01141023|
Recruitment Status : Recruiting
First Posted : June 10, 2010
Last Update Posted : August 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: DaTscan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||680 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Parkinson's Progression Markers Initiative (PPMI)|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Datscan SPECT Imaging
Subjects will b injected with 3-5 mCi of dopamine transporter. Within a 4 hour (+/- 30 minutes) window following the injection, subjects will undergo SPECT imaging on the camera.
Other Name: Ioflupane
- Mean Rates of Change [ Time Frame: Baseline to 156 months ]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 various subsets (including, but not limited to: PD vs. healthy subjects, PD vs. SWEDD, PD vs. prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation carriers vs. healthy controls) at study intervals ranging from 3 months to 36 months. Specific examples of outcomes include MDS-UPDRS, dopamine transporter imaging striatal uptake, vesicular monoamine transporter type-2 uptake, and serum and CSF alpha-synuclein. PD patient subsets may be defined by baseline assessments, genetic mutations, progression milestones and/or rate of clinical, imaging, or biomic change.
- Comparison between Rates of Change [ Time Frame: Study intervals ranging from 3 months to 156 months ]Comparison between the rates of change in the mean of clinical, imaging and biomic outcomes in various subsets (including, but not limited to: early PD vs. healthy subjects, PD vs. SWEDD, PD vs. prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation vs. healthy controls)
- Prevalence of measures of clinical, imaging and biomic outcomes in various subsets ( [ Time Frame: study intervals ranging from baseline to 156 months. ]Including, but not limited to: early PD patients, healthy subjects, PD vs SWEDDs, PD vs prodromal, PD with and without LRRK2, GBA or SNCA mutation, unaffected LRRK2, GBA or SNCA mutation carriers vs. healthy subjects.
- Predictive Value [ Time Frame: Baseline to 156 months ]To establish the predictive value of early clinical non-motor features, baseline imaging and biomic outcomes for future course of disease.
- To examine the proportion of SWEDD subjects that have a change in their clinical management at 24 months [ Time Frame: Baseline to 156 Months ]SWEDD Clinical Diagnosis and Management Questionnaire.
- Exploratory Analysis [ Time Frame: Baseline to 156 months ]Exploratory analysis to estimate the percentage of Prodromal subjects with one or more risk characteristics [hyposmia (<10th percentile for age and gender), RBD, or LRRK2, GBA or SNCA genetic mutation, and baseline DaTSCAN binding showing minimal to moderate DAT deficit] that phenoconvert to PD within 2 years, and an exploratory analysis to examine whether the baseline DaTSCAN binding or progression of clinical, imaging, or biospecimen markers may predict those subjects likely to phenoconvert.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141023
|Study Chair:||Kenneth L Marek, MD||Institute for Neurodegenerative Disorders|
|Study Director:||John Q. Trojanowski, MD, PhD||University of Pennsylvania|
|Study Director:||Arthur W. Toga, PhD||University of California, Los Angeles|
|Study Director:||Tatiana Froud, PhD||Indiana University|
|Study Director:||Karl Kieburtz, MD||Clinical Trials Coordination Center|
|Study Director:||Andrew Singleton, PhD||Laboratory of Neurogenetics; National Institute on Aging NIH|
|Study Director:||John P Seibyl, MD||Institute for Neurodegenerative Disorders|
|Study Director:||Christopher Coffey, PhD||Clinical Trials Statistical and Data Management Center, University of Iowa|