About PPMI
The Parkinson’s Progression Markers Initiative (PPMI) is an observational research study to identify biomarkers of Parkinson’s disease (PD) progression. A biomarker is a substance or characteristic in our bodies that is associated with the presence of disease, or that changes over time in a way that can be linked to the progression of disease. An observational study means that study participants will undergo numerous tests and assessments of bodily processes related to PD, but will not receive an experimental drug or treatment. This study will use a combination of imaging techniques, collection of blood, urine, and spinal fluid, and clinical tests.
The information gathered from these procedures is critical to the future development of new and better treatments for Parkinson’s disease. PPMI is the first clinical study to assemble a population of sufficient size to collect this information, draw meaningful scientific conclusions over time, and try to develop better ways to measure the progression of PD.
The study is currently running underway in 21 sites throughout the United States and Europe. It is expected to take about five years. The study team includes many clinicians and scientists who conduct research in Parkinson’s disease. It will be led by principal investigator Ken Marek, MD, President and Senior Scientist of the Institute for Neurodegenerative Disease, New Haven, Connecticut. Expansion of the study to Australia will make this a truly global study.
What are biomarkers?
A biomarker can be any objectively measurable physical characteristic associated with the presence of disease (diagnostic marker), or any characteristic that changes over time in a way that can be tied to the progression of disease (progression marker). Examples from other health conditions include: Blood pressure, which is objectively and easily measured and, when high, acts as a diagnostic marker of potential heart disease; and, white blood cell count is a progression marker of leukaemia. A count that rises to abnormal levels indicates that the condition is getting worse, while a count that returns to normal indicates improvement.
Why are biomarkers so important?
Purpose of the Research
The goal of the PPMI study is to identify one or more biomarkers of Parkinson’s disease. The discovery of a biomarker of Parkinson’s disease is critical to the development of new and better treatments for PD, particularly treatments that could slow or stop the progression of the disease, something no currently available treatment can do.
Who Is Eligible to Enroll?
PPMI requires the participation of Parkinson’s patients who are newly diagnosed and are not currently taking standard PD medications and control patients – individuals who do not have PD and are not a first-degree relative of a PD patient. Participants must be at least 30 years of age.
What Is the Visit Schedule?
Interested participants will be provided with detailed information by the study team. Those who consent will be screened for eligibility. If enrolled, participants will undergo four patient visits in their first year, with visits twice a year thereafter.
How can I get involved in the study in Australia
If you would like to be involved in the study please contact the study site directly via phone or email.
Macquarie Neurology at Macquarie University Clinic, Macquarie University, Sydney, NSW
Phone: (02) 9812 3743
Email: macneuro@me.com
Website: www.macquarieneurology.com.au
Please Note: Participants will be required to travel to Macquarie University in Sydney for the study
FREQUENTLY ASKED QUESTIONS
WHO CAN TAKE PART IN PPMI?
PPMI seeks to enroll participants from two groups: controls who do not have PD and 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. Once enrolled, subjects will participate in the study through to 2015
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?
After the first (screening) visit, you will visit the site upon enrolling andagain at 3, 6, 9 and 12 months. Visits will then occur every 6 months until the study is over. 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.
DO PARTICIPANTS HAVE TO GO TO A PPMI SITE TO PARTICIPATE IN THE STUDY?
Yes. Because the study has been designed with highly standardised protocols that must be strictly adhered to across study sites, enrolled subjects must visit the official PPMI site to conduct all study visits.
HOW LONG WILL THE STUDY LAST?
PPMI will be conducted over the course of about five years. For individual participants, the duration will range from three to five years depending on their particular study entry date.
IF I ENROLL, DO I HAVE TO STOP SEEING MY CURRENT PHYSICIAN?
No, you are encouraged to maintain your relationship with your doctor.When you come for study visits as a PPMI participant you will be evaluated by an experienced clinical research team. All other decisions about your medical care outside of the study are up to you. PD patients who enroll in PPMI may elect to have the PPMI study site share test results and clinically relevant findings with their personal physician.
WHO IS SPONSORING THIS RESEARCH?
PPMI is sponsored by The Michael J. Fox Foundation for Parkinson’s Research,and funded in Australia by The Shake It Up Foundation.
I DON’T QUALIFY FOR PPMI, BUT I STILL WANT TO HELP. WHAT CAN I DO?
Please help us spread the word to people who might be interested in participating. If you know someone recently diagnosed with PD, or someone who does not have PD and is not a first-degree relative (parent, child, sibling)of a PD patient, please refer them to the study site. (Details Above)
I AM INTERESTED IN PARTICIPATING IN CLINICAL TRIALS. HOW DO I FIND OUT ABOUT OTHER TRIALS RUNNING IN MY DEMOGRAPHIC?
Absolutely, if you did not meet the criteria for the PPMI study please consider setting up a profile on the Fox Trial Finder and be matched with other studies running in your demographic which you could participate in.
To register for Fox Trial Finder Click Here
For more information on PPMI Click Here
To register for Fox Trial Finder Click Here
