The Michael J Fox Foundation in the US has launched what it describes as the first ever large-scale clinical trial devoted exclusively to identifying and validating biomarkers for Parkinson’s disease.
The Parkinson’s Progression Markers Initiative (PPMI) will be conducted at 18 sites across the US and Europe, and is expected to cost US$40 million over a five-year span. Funding will come from the Foundation, board member Lily Safra and industry partners such as Pfizer and GE Healthcare.
The observational study will track 400 newly diagnosed Parkinson’s patients who have not yet started taking medication and 200 individuals who do not have Parkinson’s disease. It will look at the most promising biomarkers for disease progression through neuro-imaging, blood, urine and spinal fluid samples, and clinical and behavioural tests.
Biological samples and rich clinical data from the PPMI will be made available to qualified researchers around the world. Any progression biomarkers for Parkinson’s disease identified through the study will enable researchers to establish objective endpoints for clinical trials of disease-modifying treatments, noted Dr Kenneth Marek, principal investigator and president of the Institute for Neurodegenerative Disorders in New Haven, US.
Currently no known biomarker for Parkinson’s exists and patients only have access to therapies that temporarily alleviate the symptoms of the disease, the Michael J Fox Foundation pointed out.