Study Aims to Identify Biomarkers that may Enhance Drug Development Efforts to Slow or Stop Progression of the Disease
Cleveland Clinic has been selected as a site for the Parkinson’s Progression Markers Initiative (PPMI), a landmark five-year research study sponsored by the Michael J. Fox Foundation that aims to identify biomarkers of the disease.
Newly diagnosed Parkinson’s disease patients throughout Ohio can now participate in this observational study and be a part of an important step in seeking a cure for the disease.
PPMI is the first large-scale international research study exclusively focused on establishing the scientific infrastructure necessary to develop Parkinson’s disease biomarkers. A biomarker is a substance, process or characteristic in our bodies that is associated with the risk or presence of a disease, or that changes over time in a way that can be linked to the progression of a disease. Reliable and consistent biomarkers would allow scientists to predict, objectively diagnose and monitor diseases, as well as definitively determine which medications work and which will not. There is currently no known biomarker for the progression of Parkinson’s.
“Finding a biomarker would be a major game changer, because it could establish a critical endpoint for knowing the effectiveness of drugs. These are concrete ways to demonstrate that a treatment is, or is not, impacting the disease process in Parkinson’s patients, as opposed to simply impacting disease symptoms,” said Hubert Fernandez, MD, Head of Movement Disorders in the Center for Neurological Restoration at Cleveland Clinic, and site Principal Investigator for the PPMI study. “We can’t keep testing drugs on large sets of patients over long periods of time and finding equivocal or negative results. It takes too long, it costs too much to conduct the research, and too many lives are involved. If we had a biomarker that correlates with disease progression, we would need fewer patients, less time, less funding and we’d be able to help more people faster, which is the most important part.”
PPMI is an observational study as opposed to an interventional trial. No experimental drugs will be measured or used in this trial. Participants will be contributing to a large body of data and biological specimens that can be used to further biomarker research. PPMI participants will not only contribute bio-samples – blood, urine, and spinal fluid –but also undergo a wide range of clinical and behavioral assessments.
As part of its site responsibilities, Cleveland Clinic is planning to enroll 20 newly diagnosed Parkinson’s patients who have not yet used any medications for their disease and 10 healthy controls, who cannot be first-degree blood relatives of the patients. Subjects enroll for three to five years, depending on when they are recruited.
Cleveland Clinic’s Center for Neurological Restoration has been responsible for many breakthroughs in treating Parkinson’s disease, including being one of the earliest innovators for deep brain stimulation (DBS) and being able to offer relevant and cutting each clinical trials for all stages of Parkinson's from the newly diagnosed to the most advanced. The Center is among the first in the world to bring together an interdisciplinary team of renowned neurologists, neurosurgeons, psychiatrists, neuropsychiatrists, researchers and other specialists who offer the latest medical and surgical treatments for patients with neurological and psychiatric disorders. The center is nationally recognized for expertise in medical management and innovations in the surgical treatment of movement disorders (Parkinson’s disease, essential tremor or dystonia) as well as psychiatric disorders such as obsessive-compulsive disorder and depression.
For more information on the study, call Adrienna Winters at 2164455637 or visit www.ppmi-info.org.
About Cleveland Clinic
Celebrating its 90th anniversary, Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. It was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. About 2,800 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. Cleveland Clinic Health System includes a main campus near downtown Cleveland, nine community hospitals and 15 Family Health Centers in Northeast Ohio, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and opening in 2013, Cleveland Clinic Abu Dhabi. In 2010, there were 4 million visits throughout the Cleveland Clinic health system and 155,000 hospital admissions. Patients came for treatment from every state and from more than 100 countries. Visit us at www.clevelandclinic.org. Follow us at www.twitter.com/ClevelandClinic.