Cognext Diagnostics LLC — Department of Health and Human Services SBIR Phase I: NIA

Description

Project Summery Alzheimerandapos s diseaseADrepresents a major medicalpublic healthand health system crisisIn the United StatesAD is theth leading cause of deathkilling more than breast cancer and prostate cancer combinedAD currently afflictsmillion Americans and prevalence is expected to triple byThe need for early diagnosis and treatment of AD is widely recognized as a high unmet need and is therefore the focus of major pharmaceutical and diagnostic companiesIn this proposal we will develop a novel cerebrospinal fluidCSFand blood assays to address the need for early identification of patients at risk for cognitive deterioration in ADBuilding on prior workour assays hold the potential for early stratification of patients at risk for AD and for monitoring response to therapyThe proposed tests are based upon our laboratoryandapos s discovery that measured levels of the NPTX protein found in CSF are associated with their cognitive statusWe aim to develop a pre commercial prototype ELISA assay and evaluate expanded clinical patient samples to evaluate the further utility and analytical parameters of the NPTXassays in CSFWe will also evaluate blood based assays of NPTXCritical milestones includeValidate the sensitivityspecificity and reproducibility of NPTXELISA using human CSFAssess the utility of NPTXmeasures in CSF inhuman cerebrospinal fluid samples from patients monitored by the Alzheimerandapos s disease research centerADRCat University of California San DiegoUCSDto distinguish control from AD subjects in a cross sectional analysisand determine the value of CSF NPTXmeasures to predict progression of cognitive failure in longitudinal follow upEvaluate the performance of CSF NPTXrelative to other biomarkers that are widely used in the diagnosis of AD including Atauphospho tauand synaptic proteinsWe will test hypotheses from our published work that NPTXprovides unique information regarding theresilienceof the brain to effects of Aamyloid and tauand that a combined measure that includes NPTXcan enhance the diagnostic performance of tauXiao et alAdditionallywe will optimize methods for the isolation and assay of brain derived exosomes from blood plasma and assess efficacy of plasma NPTXmeasures to distinguish AD patients from normal controlsFindings will provide a basis for negotiations with potential corporate sponsors including bio technesee letter of supportand Roche Diagnostics GmbHand will be evaluated as a basisin partfor a new companyCogNext Diagnostics Project Narrative This project will focus on validating tools to measure a novel biomarkerNPTXand evaluate its utility as a marker of brain function relevant to cognitive decline in ADTool development includes an ELISA kit used to measure NPTXin CSF samplesand a simplified technique to isolate brain derived exosomes for measures of NPTXin blood plasma