Researchers and drug companies with an interest in Parkinson’s disease now have a new vital tool to aid them in the search for better treatments for the condition, in the form of a brain scan that can be used to select the right people for clinical trials.
Studies suggest that up to 15% of individuals taking part in clinical trials may not have Parkinson’s. Therefore they are extremely unlikely to benefit from the new therapies being tested and their inclusion can adversely affect both trial results and the future of the potential treatment.
Parkinson’s is a progressive condition, caused by the gradual loss of cells in the brain, so the best chance to intervene with treatments that can slow, stop or reverse the damage is during the earliest stages of the condition. However, during these early stages, symptoms tend to be mild which makes it difficult to select the right people to participate in trials.
The brain scan can produce a picture of how dopamine producing cells (which are destroyed by the disease) are functioning inside the brain.
It can help distinguish between people who have Parkinson’s (or a similar progressive condition) and those with a condition like essential tremor, which is unlikely to worsen over time.
These brain scans have become the first enrichment biomarker – which is a test that can be used to select people who are most suitable to take part in clinical trials – for Parkinson’s qualified by the European Medicines Agency. The European-wide regulatory body now therefore encourages the use of these brain scans in clinical trials for new treatments in Parkinson’s. It is also the first ever biomarker qualified for the condition.
Professor David Dexter, Deputy Research Director of Parkinson’s UK, said: “Scientific breakthroughs mean that there is now a new wave of exciting treatments that genuinely could slow, stop or reverse the condition coming through, but it’s crucial that we’re able to test them properly in clinical trials.
“This is a vital step forwards in our mission to deliver better treatments, and one day a cure, to people living with Parkinson’s as quickly as possible.”
Dr. Diane Stephenson, Executive Director of the Critical Path for Parkinson’s consortium, which led this work, added: “We’re delighted that this endorsement from the EMA will improve the quality and chances of success for all future trials. This success is just the first in a suite of new tools that we hope to deliver for Parkinson’s.”