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Report for Clinical Trial NCT01141023

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

The Parkinson's Progression Markers Initiative (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.

NCT01141023 Parkinson Disease
MeSH:Parkinson Disease

1 Interventions

Name: DaTscan

Type: Drug
Group Labels: 1

Datscan SPECT Imaging


Primary Outcomes

Description: 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.

Measure: Mean Rates of Change

Time: Baseline to 156 months

Secondary Outcomes

Description: 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)

Measure: Comparison between Rates of Change

Time: Study intervals ranging from 3 months to 156 months

Description: 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.

Measure: Prevalence of measures of clinical, imaging and biomic outcomes in various subsets (

Time: study intervals ranging from baseline to 156 months.

Description: To establish the predictive value of early clinical non-motor features, baseline imaging and biomic outcomes for future course of disease.

Measure: Predictive Value

Time: Baseline to 156 months

Description: SWEDD Clinical Diagnosis and Management Questionnaire.

Measure: To examine the proportion of SWEDD subjects that have a change in their clinical management at 24 months

Time: Baseline to 156 Months

Description: 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.

Measure: Exploratory Analysis

Time: Baseline to 156 months

Purpose: Other

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 N370S

Addition of PPMI Pathology Core/PPMI Brain and Tissue Bank Addition of Gait Assessment Companion Study (Select PPMI sites - Genetic Cohort only) Testing for additional GBA mutations - previously testing involved testing only for the GBA N370S mutation; however, going forward, testing will include tests for additional GBA mutations that are identified as being associated with certain ancestry. --- N370S ---



HPO Nodes