Study Design

The Parkinson’s Progression Markers Initiative (PPMI) is a longitudinal, observational, multi-center natural history study. PPMI assesses progression of clinical features, imaging outcomes, biologic and genetic markers, and digital outcomes of Parkinson’s disease across all stages of PD from prodromal to moderate disease. The overall goal of PPMI is to identify markers of disease progression to accelerate therapeutic trials to reduce progression of PD disability.

The PPMI Clinical protocol is designed to acquire comprehensive longitudinal within-participant data in approximately 4000 participants enrolled at about 50 sites worldwide. PPMI clinical prodromal participants will largely be identified through a stage risk paradigm beginning with a custom-built remote platform called PPMI online. The prodromal pyramid is shown below and demonstrates the pathway from PPMI online to PPMI Remote and finally to PPMI clinical.

View each on the Research Documents & SOPs page.

PPMI Clinical

In-person longitudinal clinical and imaging assessments and biosample collection taking place at ~50 international sites.

PPMI Remote

Remotely administered olfactory and, in some, genetic testing among people selected based on patient reported outcomes (PROs) or information from clinical sites.

PPMI Online

Patient-reported outcomes collected online from people with and without PD.

All PPMI clinical participants will also participate in PPMI online longitudinally. All PPMI online participants will have the opportunity to participate in PPMI Digital, a mobile phone application developed by Roche. PPMI participants may also be asked to participate in additional PPMI companion studies. (See Sub Study Page.)

Data Availability

PPMI has created a comprehensive uniformly acquired data set and biosample repository available to the PD research community. PPMI offers the opportunity to expand and transform the use of biomarkers to test hypotheses of the underlying molecular pathobiology of PD, enable modeling of PD progression to identify clinical and/or biologic data driven PD progression sub-sets, and inform studies testing PD therapeutics including clinical trials targeting synuclein, LRRK2, GBA and other targets.

Availability and analysis of these data and samples serves to:

  • Identify biomarkers of PD progression to accelerate therapeutics to slow PD disability
  • Develop quantitative measures that demonstrate optimum interval change from prodromal PD to diagnosis
  • Demonstrate preferred study methodology to allow cross-study comparison

Study Synopsis - PPMI Clinical

Study Population*
Target N = 4000+
Clinical Data Collection Biologic Collection
1,000 Enrolled
2010-2018
  • Motor Assessments
  • Neurobehavioral/Neuropsychiatric Testing
  • Autonomic, Olfaction, Sleep Testing
  • DaTSCAN, MRI, and other imaging sub-studies
  • Digital Data
  • Online patient reported outcomes (PROs)
  • DNA, RNA
  • Whole Blood, Serum, Plasma, Urine
  • CSF
  • iPSC in Subset of 2010 - 2018
  • Skin biopsy
  • Post-mortem tissue
500 PD
100 HC
400 Prodromal PD
3,000 Enrollment Goal
2020-2023
900 PD
100 HC
2000 Prodromal PD

*Sample size numbers are approximate.