NeuroDex will develop a blood-based test for Lewy bodies, and potentially for TDP43 pathologies. This test will be based on a robust method for isolating neuro-derived extracellular vesicles’ (NDEs) from blood plasma. NDEs are small vesicles that carry cargo from cells they’ve been shed. NeuroDex’s unique methods enable viewing NDEs’ contents and getting a pathological “snapshot” of the brain cells they originated from.

Major advancements in Alzheimer’s pathology biomarkers in the last 15 years have revolutionized diagnosis and clinical trials. However, lack of stratification of patients with mixed pathologies (i.e. Alzheimer’s and other diseases) in clinical trials and patient treatment has potentially affected their outcomes. Postmortem analysis shows that over 85% of dementia cases, including cases diagnosed as Alzheimer’s, actually have mixed pathologies. The existence of more than three different pathologies in a patient is more common than pure Alzheimer’s (amyloid and tau pathology only). Common co-pathologies include Vascular, Lewy Bodies, and TDP43 protein, these contribute to disease progression. There are no available tools for excluding subjects with mixed pathologies. Furthermore, recent clinical trials show that even highly significant reduction in Amyloid protein in the brain only slightly corelated with cognitive improvement. This may be due to mixed pathologies

NeuroDex’s preliminary data demonstrates strong identification of alpha-synuclein the main component of Lewy bodies pathology in Parkinson’s disease and Lewy-body dementia, and identification of TDP43 pathology in ALS. NeuroDex intends to use the grant funds to further validate the method and reproduce the analysis in two larger cohorts.

NeuroDex hopes that by the end of the study, we will be on the verge of a new biomarker tool that can help bring precision medicine into the dementia field.