Parkinson's Progression Markers Initiative
PI: Douglas Galasko, M.D.
PPMI is a five-year observational study of PD and control participants. The study is designed to establish a comprehensive set of clinical, imaging and biosample data that will be used to define biomarkers of PD progression. Once these biomarkers are defined, they can be used in therapeutic studies, which is the ultimate goal.
PPMI will follow standardized data acquisition protocols to ensure that tests and assessments conducted at multiple sites can be pooled in centralized databases and repositories. The clinical, imaging and biologic data will be easily accessible to researchers in real time through a Web portal. The biological samples collected throughout the course of PPMI will be stored in a central repository that will be accessible to any scientist with promising biomarker leads for the purposes of verifying initial results and assessing correlations to clinical outcomes and other biomarkers. Only with collaborative efforts like PPMI can we efficiently identify and validate biomarker candidates for PD progression.
Who can take part in PPMI?
PPMI seeks to enroll participants from two groups: 200 controls who do not have PD and 400 Parkinson’s or “possible PD” patients (these can be patients who are newly diagnosed and have taken medication for less than 60 days or, ideally, patients who have not yet started taking PD medication; patients with possible PD are also highly qualified for the study). Participants must be at least 30 years of age. Volunteers will be enrolled in PPMI through summer 2012. Once enrolled, subjects will participate in the study through summer 2015, completing three to five years of study visits depending on their enrollment date.
A patient I recently diagnosed with PD has not yet begun medication, but may need to start soon. Can s/he still participate in PPMI?
Yes, and in fact, patients like these are the most appropriate subjects for the study. If possible, enrollees are asked to stay medication-free for the first six months of participation. For many newly diagnosed patients who take part in PPMI, it will become necessary to start PD medications at some point during the course of the study. Starting PD meds at any point after enrolling in PPMI does not compromise a patient’s eligibility to participate. Further, PPMI sites acknowledge that all treatment decisions are of primary importance and should be determined solely between the patient and his or her primary doctor.
What is the visit schedule for individuals who enroll in the study?
Participants will be required to make four study visits in their first year, with visits twice a year thereafter. Each visit will include different tests, assessments and biologics sampling, including motor, neuropsychiatric and cognitive assessments; DatSCAN and MRI imaging; and, blood, cerebrospinal fluid (CSF), urine and DNA sampling.
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To participate contact:
Christina Gigliotti, Ph.D. or Deborah Fontaine, N.P. at 858-822-4800