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PPMI 2.0 is a broad program, expanding the goals of the original PPMI study (NCT01141023), that includes this PPMI 2.0 Clinical protocol, as well as the PPMI 2.0 Remote, PPMI 2.0 Digital Applications and PPMI 2.0 Online protocols.

All participants in PPMI 2.0 will be asked to be enrolled in all PPMI 2.0 protocols, but depending on their method of recruitment, participants may be enrolled sequentially in varying order, as appropriate. PPMI 2.0 participants may also be asked to participate in additional PPMI 2.0 companion studies (as they are developed), which may only involve a subset of PPMI 2.0 participants based on their cohort designation and/or site location.

Purpose

The purpose of this study is to obtain information from people with and without Parkinson disease (PD) so researchers may better understand how PD progresses, and develop better treatments.

Who Can Participate

Healthy Controls and patients diagnosed with Parkinson’s disease.

Parkinson’s Disease Requirement

  • A diagnosis of Parkinson’s disease for two years or less at screening visit
  • Not expected to require Parkinson’s disease medication within at least six months from baseline
  • Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia)
    • OR either asymmetric
    • OR Parkinson’s disease (PD) with LRRK2 or GBA mutation
  • Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or documentation of prior genetic testing results)
    • OR Prodromal PD (RBD, genetic mutation carriers)

Visits

Patients can expect 12 visits over five years.

Status
Open and enrolling subjects.
Location
Phoenix, Arizona
Total Participants
4500
Primary Sponsor
Michael J. Fox Foundation for Parkinson's Research
Additional Sponsor(s)
Institute for Neurodegenerative Disorders