For information on the study, call the Gardner Center at 866-941-8264. For an appointment with a UC Health neurologist, call 513-475-8730.
UC HEALTH LINE: Study Seeks to Identify Parkinson's Biomarkers
CINCINNATIóA landmark clinical study called the Parkinsonís Progression Markers Initiative (PPMI) will seek to identify biomarkers of Parkinsonís disease progressionóand also provide a chance for volunteers to help in the fight against Parkinsonís.
The James J. and Joan A. Gardner Center for Parkinsonís Disease and Movement Disorders of the University of Cincinnati (UC) Neuroscience Institute is participating in the study and is currently accepting volunteers. The Gardner Center, directed by Fredy Revilla, MD, an associate professor of neurology at UC, is one of nine centers within the UC Neuroscience Institute, a specialty institute within UC Health.
Parkinsonís disease is a chronic, degenerative neurological disorder in which certain dopamine-producing cells in a region of the brain begin to die. When these cells die, neurons in the brain fire erratically, leaving patients less able to direct or control their movements. There is no known cure for Parkinson's disease; the goal of current treatment is to control symptoms.
PPMI, sponsored by the Michael J. Fox Foundation (MJFF) for Parkinsonís Research, is a five-year international study aimed at measuring the progression of Parkinsonís by finding biomarkers. A biomarker is a substance, process or characteristic in the human body that is associated with the risk or progression of a disease, or that changes over time in a way that can be linked to the diseaseís progression.
There is no known biomarker for the progression of Parkinsonís. If one were found, researchers say, it would enable scientists to measure biological differences between people with Parkinsonís and without, and track the progression of the disease in patientsí brains and bodies.
Actor Michael J. Fox is the founder of the foundation and has lived with Parkinsonís disease for over 20 years.
PPMI needs 400 newly diagnosed Parkinson's patients who have not yet begun medication and 200 control participants who do not have Parkinson's or a close relative with Parkinson's.
"Finding a biomarker would represent a turning point in the history of Parkinsonís disease,Ē says Alberto Espay, MD, a Gardner Center neurologist and associate professor of neurology at UC who is leading the PPMI effort in Cincinnati. "It could give us the tools to translate some of the abnormalities of this disease into a set of tests that could reliably establish the diagnosis and give us, for the first time, a measure of the trajectory patients could be expected to follow.
"In addition, this will greatly strengthen the logistical infrastructure needed to develop neuroprotective therapies in Parkinsonís disease.Ē
"The lack of a disease modifying therapy is the major unmet need for those living with Parkinsonís disease today,Ē says Todd Sherer, PhD, CEO of the foundation. "For years, the Michael J. Fox Foundation has funded research into biomarkers toward helping to speed the development of therapies with the potential to alter disease progression. Now, PPMI is bringing researchers, funders and study participants together to take this search to the next level in a unified effort to unlock new discoveries in biomarker development."
With Parkinsonís biomarkers in hand, the study could establish definitive endpoints for clinical trials of disease-modifying treatments and better characterize patients for specific trials, reducing the need for larger samples. With concrete ways to determine whether a therapy is impacting disease course or not, evidence-based decision-making would be greatly facilitated.
PPMI is an observational study, not an interventional trial. No experimental drugs are being used or measured. Participants contribute to a large body of data by undergoing various tests, including a brain scan that measures dopamine and spinal fluid analyses of various enzymes and molecules. Patients with Parkinsonís disease and healthy volunteers are compensated for their time and travel.
About the Parkinsonís Progression Markers Initiative PPMI, a groundbreaking study to find biomarkers of Parkinsonís disease, will be carried out over five years at 24 clinical sites in the United States, Europe and Australia. The study will enroll 400 de novo Parkinsonís patients (patients who are newly diagnosed and have not yet taken PD medication) and 200 healthy age-matched controls. Participants will undergo tests including motor, neuropsychiatric and cognitive examinations; brain imaging with DatSCAN and MRI; and blood, CSF, urine and DNA sampling.
About the Michael J. Fox Foundation The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinsonís disease through an aggressively funded research agenda. MJFF has funded over $275 million in research to date.