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The European Medicines Agency (EMA) has issued a positive rating opinion on an imaging test, or biomarker, to be used as a tool to improve Parkinson's clinical trials, according to the Critical Path Institute of Tucson, Arizona. for the Parkinson Consortium (CPP), which hailed the EMA qualification as the first regulatory designation for a Parkinson's biomarker.
The EMA Movement follows a 2015 letter by the US Food and Drug Administration supporting the use of imaging testing in clinical trials to determine the presence of a disability Dopamine transport in the brain to help target the early stages of Parkinson's disease. The biomarker involves the intravenous injection of a small amount of a radioactive tracer before the brain images are acquired. Brain scans are already included in new clinical trials by Cambridge, MA-based Biogen.
Because disease is a progressive condition caused by progressive loss of cells in the brain, researchers say the best chance of intervening with treatments that can slow down, stop or reverse the damage during the early stages of the disease, making it more difficult to predict progression of the disease during the trials.
"This approval by the European Medicines Agency represents many years of hard work and unbelievable collaboration between companies, universities and charities is facilitated by the Critical Path Institute," said Dr. Diane Stephenson, Director General of CPP, who led the work. "These brain scans by themselves are not new, but until now there is no clear consensus on their ability to select participants for clinical trials. "
CPP consortium, in partnership with Parkinson & # 39; s UK, collaborates with industry, academics, advocacy organizations and government agencies to develop solutions to optimize the development of Medicines for Parkinson's Disease.
Traditionally, Parkinson's disease is considered a dopamine disorder. are nervous in their brains are dead. Current research indicates that processes leading to dopamine deficiency begin decades earlier, which makes it urgent to understand the progression of Parkinson's disease, according to the CPP
( Source: Critical Path Institute, 1945, p.])
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