The test is transforming today ’ s crop of clinical trials .
YEAR ONE OF THE NEW BIOMARKER
THE MICHAEL J . FOX FOUNDATION 2024 YEAR IN REVIEW
The New Tool at Work in Clinical Trials
By detecting Parkinson ’ s disease biology even before outwardly observable symptoms show up , the aSyn-SAA biomarker test is transforming today ’ s crop of clinical trials . Researchers can , for the first time , objectively measure biological results of the drugs they are testing in Parkinson ’ s and at-risk populations . By confirming that PD ’ s abnormal alpha-synuclein is present in people who are being enrolled for clinical testing , it ensures the right people are enrolled in trials based on their biology .
The test is transforming today ’ s crop of clinical trials .
In the past , clinical trials relied on subjective assessment of symptom progression over time , as measured by the Unified Parkinson ’ s Disease Rating Scale ( UPDRS ). Before the biomarker test , it was impossible to know whether clinical trial participants were affected by the biological changes targeted by a given drug . Under those conditions , it is entirely possible and even likely for a trial to “ fail ” to reach its endpoints when , in fact , the problem is that the drug was unwittingly being tested in the wrong population .
Measuring the amount of aggregated alpha-synuclein will help today ’ s investigators learn how treatment affects the progression of the disease over time , especially with the advent of quantitative testing , which would help investigators assess treatment effects biologically and track these results against functional benefit .
Several clinical trials are already making use of aSyn-SAA . Biotech company Vaxxinity used SAA to determine if its aSyn vaccine elicits a response , finding that it reduces the SAA-positivity signal . The Phase I trial was funded by MJFF in collaboration with the Mayo Clinic and UTHealth Houston . Many prior trials testing Parkinson ’ s
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