A group of Parkinson’s scientists, charity organisations, and patient advocates from around the world have collaborated to help develop a new biological staging framework for Parkinson’s.
Cure Parkinson’s is part of this initiative, which emphasises the growing need to redefine how we view Parkinson’s based on our understanding of its biology to improve the drug development process and overall experiences of people with Parkinson’s.
A key component of this new framework is developing and using tests able to assess Parkinson’s biology directly. This is done through evaluating biomarkers – measurable indicators of what is occurring in the body. A paper recently published in Lancet Neurology highlights two biomarker tests that could be used to monitor Parkinson’s progression in clinical trials:
- An alpha-synuclein detection test
- Analysis of the presence of dopamine in the brain (DaTSCAN imaging)
Learn more about each of these tests here
Alpha-synuclein Detection Test
Alpha-synuclein is a protein found most abundantly in our brain cells (neurons). In people with Parkinson’s, dysfunctional alpha-synuclein protein builds up, forming structures called “Lewy bodies”, which interfere with cell functioning and may eventually lead to cell death. This new test would allow researchers to detect the presence of abnormal alpha-synuclein in the cerebrospinal fluid (CSF). CSF, the fluid surrounding the brain and spinal cord, gives a better representation of the changes occurring in the brain than that given in a blood sample.
DaTSCANs
DaTSCAN is a brain imaging technique which detects the presence of dopamine-producing neurons, the type of brain cell lost in Parkinson’s. Monitoring dopamine levels may indicate if a treatment is able to slow neuron loss. DaTSCANs are already in use to aid in some Parkinson’s diagnoses, as well as being used in clinical trials, including in the ongoing Cure Parkinson’s supported Phase 3 trial of Exenatide.
Why do we need new tests?
Over the past decade, we’ve seen significant developments in our understanding of the underlying biology that may be driving Parkinson’s progression. Our current methods of diagnosing and monitoring Parkinson’s, though, do not reflect this as they still rely heavily on subjective, clinician-based symptom assessments.
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Parkinson’s is not the same for every person, however, and these tests can leave many people, especially those in the early or prodromal stages, without an accurate diagnosis. Additionally, symptom severity can often change, making it difficult to accurately track these in the clinic. Therefore, finding tests that tell us what is actually occurring in the brain may help us begin to fill in these gaps.
This is especially important for clinical trials as we need to be able to identify the individuals best suited to take part and have the right tools to evaluate whether a treatment is working.
Adding precision to our clinical trials is vital. If we are able to involve the right people for the right trials through the inclusion of these tests, that would be a big step forward and will enable us to gain clearer answers evaluated on biology rather than clinical assessments.
Helen Matthews, CEO, Cure Parkinson’s
What does this mean for people with Parkinson’s?
For now, these tests are only intended to be used in clinical trials. However, as these methods develop and improve, they may eventually become diagnostic tools too. Overall, what these tests and, more broadly, this global collaboration represent are efforts to move us closer to both achieving our goal of finding a cure and to improve the clinical experience and outcomes for people with Parkinson’s.
This initial framework is just the beginning. These two tests are a great start but there are lots of exciting advances happening in this field at the moment so we hope to see more sensitive (and patient friendly) tests added into the framework in the near future.
Professor David Dexter, Director of Research, Parkinson’s UK
For more information on the proposed staging system, Gary Rafaloff and Katie Kopil discussed this in greater depth at September’s Rallying to the Challenge meeting: