Study Rationale:
Early detection of neurodegenerative diseases can lead to more effective therapeutic intervention. DiamiR proposes a diagnostic approach based on analysis of microRNAs in plasma. microRNAs are a class of RNA molecules that, due to their small size, can cross the blood-brain barrier and appear in the bloodstream. In several studies microRNA biomarker signatures differentiated mild cognitive impairment patients from age-matched controls with up to 96% accuracy. Another study showed Parkinson’s disease (PD) patients were differentiated from age-matched controls with accuracy of 90 to 100%.
Hypothesis:
The goal of this study is to validate identified microRNA biomarker pairs for PD detection in a larger, well-characterized cohort of plasma samples from the BioFIND study.
Study Design:
RNA will be isolated from plasma of 50 PD patients and 50 age/gender-matched controls, and levels of 18 pre-identified microRNAs will be measured. Rigorous statistical methods will be applied to evaluate the biomarkers’ ability to differentiate PD samples from controls.
Impact on Diagnosis/Treatment of Parkinson’s Disease:
There is a great need for easily accessible, cost-effective, noninvasive diagnostic and screening tests of early stages of Parkinson's disease. Early disease detection and subsequent disease and treatment monitoring could lead to more efficient enrollment into clinical trials and enable effective treatment as well as better planning by patients and caregivers.
Next Steps for Development:
If the microRNA biomarkers are successfully validated in this study, we will then work on assessing their ability to detect PD at early (asymptomatic) stages and evaluate their levels at various stages of PD development. The most effective biomarker signatures will be selected for the development of clinical tests.