From today forward, researchers and drug companies have a new tool in the search for better treatments for Parkinson’s – 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. They are extremely unlikely to benefit from the new therapies being tested and their inclusion can affect both the trial results and ultimately the future of the potential treatment.
Because Parkinson’s is a progressive condition, caused by the gradual loss of cells in the brain, 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 selecting the right people to participate in trials very difficult.
Using this brain scan can produce a picture of how dopamine producing cells – which are destroyed by Parkinson’s – 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 – 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. This means that the European-wide regulatory body now 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 Parkinson’s.
Professor David Dexter, Deputy Research Director of Parkinson’s UK, who fund the Critical Path for Parkinson’s consortium, comments:
Scientific breakthroughs mean that there is now a new wave of exciting treatments that genuinely could slow, stop or reverse condition coming through, but it’s crucial that we’re able to test them properly in clinical trials.
Being able to rule out individuals who are unlikely to have Parkinson’s could be the difference between a successful trial and failure.
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, comments:
This endorsement from the European Medicines Agency represents many years of hard work and incredible collaboration between companies, universities and charities facilitated by the Critical Path Institute.
These brain scans in themselves are not new, but until now there has not been a clear consensus that they can and should be used to select participants for clinical trials in this way.
Through our global project we’ve been able to bring all the data and expertise together to make a powerful case, so 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.”
Dr. Michael Ehlers, Executive Vice President of Research and Development at Biogen, said:
The use of these brain scans is already being included in new clinical trials at Biogen.
We believe that this new approach will introduce greater efficiency in terms of cost and speed while ensuring that the right patients are being included in our trials.”
Lesley Gosden, person with Parkinson’s and clinical trial participant:
I dream of an improvement in quality of life and a release from the constant discomfort, whether this comes in the form of a treatment or preferably a cure.
However, to achieve this we need to improve participant selection and become better at doing clinical trials by learning from our mistakes, and creating better tools and strategies that maximise our chances of success. This scan is definitely a step in the right direction. Otherwise millions of pounds will be spent pursuing projects which could be the next big breakthrough, but will remain unproven. That’s why I’m so delighted that Parkinson’s UK are bringing the right people together to make this happen through the Critical Path for Parkinson’s.”