Study Rationale: Early indicators for Parkinson’s disease (PD), so-called biomarkers, are needed to identify subjects at risk during the earliest, prodromal stages of disease and to support clinical trials for therapies that can potentially slow PD progression. In this study, we will analyze three different proteins (dopa decarboxylase, Midkine and neurofilament light chain) that have been previously proposed as biomarkers for their ability to indicate disease and disease progression the prodromal phase of PD.
Hypothesis: We hypothesize that one or a combination of these markers in cerebrospinal fluid and/or blood can support the early diagnosis and indicate the risk-status for PD, and that these markers, alone or in combination, change continuously over time and can therefore be used to measure PD progression.
Study Design: Our study consists of three aims: First, we will identify assays that can quantify these proteins reliably and that are commercially available for further independent validation by other groups. Next, we will quantify these proteins in samples from the Parkinson Progression Marker Initiative from people with PD, healthy controls and subjects at risk of developing the disease (those with hyposmia and/or isolated REM sleep behavior disorder). Lastly, once we have quantified these proteins, we will perform data analyses to examine the available variables, such as motor progression, cognitive decline, dopamine transporter imaging or alpha-synuclein seed amplification assay results.
Impact on Diagnosis/Treatment of Parkinson’s Disease: Our project will evaluate whether these markers, alone or in combination, can help to objectively measure progression of disease, which will facilitate clinical trials aimed at preventing the motor symptoms of PD.
Next Steps for Development: Once we show that these markers, alone or in combination, can support clinical diagnosis and/or monitor progression, the results will facilitate the design and performance of clinical trials.
Trial Phase: 1-3