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Objective  The Parkinson's Progression Markers Initiative ( PPMI ) is an observational, international study designed to establish biomarker‐defined cohorts and identify clinical, imaging, genetic, and biospecimen Parkinson's disease ( PD ) progression markers to accelerate disease‐modifying therapeutic trials.    Methods  A total of 423 untreated  PD , 196 Healthy Control ( HC ) and 64  SWEDD  (scans without evidence of dopaminergic deficit) subjects were enrolled at 24 sites. To enroll  PD  subjects as early as possible following diagnosis, subjects were eligible with only asymmetric bradykinesia or tremor plus a dopamine transporter ( DAT ) binding deficit on  SPECT  imaging. Acquisition of data was standardized as detailed at  www.ppmi-info.org .    Results  Approximately 9% of enrolled subjects had a single  PD  sign at baseline.  DAT  imaging excluded 16% of potential  PD  subjects with  SWEDD . The total  MDS ‐ UPDRS  for  PD  was 32.4 compared to 4.6 for  HC  and 28.2 for  SWEDD . On average,  PD  subjects demonstrated 45% and 68% reduction in mean striatal and contralateral putamen Specific Binding Ratios ( SBR ), respectively. Cerebrospinal fluid ( CSF ) was acquired from >97% of all subjects.  CSF  (PD/HC/SWEDD pg/mL) α‐synuclein (1845/2204/2141) was reduced in  PD  vs  HC  or  SWEDD  ( P  < 0.03). Similarly,  t ‐tau (45/53) and  p ‐tau (16/18) were reduced in  PD  versus  HC  ( P  < 0.01),    Interpretation   PPMI  has detailed the biomarker signature for an early  PD  cohort defined by clinical features and imaging biomarkers. This strategy provides the framework to establish biomarker cohorts and to define longitudinal progression biomarkers to support future  PD  treatment trials.

The Parkinson's progression markers initiative (PPMI) – establishing a PD biomarker cohort