PPMI Protocol Updated

PPMI was designed to be adaptable to changing needs, targets, and opportunities in research.  In reflection of this, PPMI recently updated its study protocol to include new and revised procedures and assessments.  Below is a summary of the changes that were made:

Administrative, Editorial Changes

  • pp 2-3 updated contacts
  • pp 9-14 Protocol Synopsis ? corrections and clarifications to subject characteristics and inclusion criteria
  • pp 15-27 Schedules of Activities – modified to reflect protocol changes
  • p. 111 Publications ? new section
  • Minor administrative corrections throughout

Addition of New Objectives, Procedures, and Companion Studies

Descriptions of procedures in companion studies and descriptions of new procedures including:

  • Advance directive for clinical research participation
  • Extension of study period for SWEDDs with positive scans at Year 2 by continuing or re-inviting to return to study and followed (as per PD subjects) through Month 60
  • Objective Parkinson Disease Measurement (OPDM) finger tapping measurement
  • Companion Studies
    • Skin Biopsy
    • Amyloid Imaging ? [18F] florbetaben
    • Family History Sub-Study
    • FOUND in PPMI Registry

Revised Procedures and Companion Studies

  • Added additional time points for resting state MRI for healthy controls who did not have imaging at Baseline or Visit 04
  • AV-133 Companion Study – Amendments 2, 3
    • Acquisition protocol shortened
    • Clarified number of subjects to be enrolled, in light of genetic cohort recruitment