# Development of a Blood-based Test for Identifying Synucleinopathy in Patients with Dementia

> **NIH NIH R44** · NEURODEX INC · 2022 · $449,999

## Abstract

PROJECT SUMMARY
In this Fast Track SBIR application, NeuroDex, Inc. proposes to use its expertise in extracellular vesicle (EV)
immunoaffinity isolation to develop a blood test that detects synucleinopathies with high sensitivity, with the long-
term goal of helping clinicians identify patients for whom antipsychotic drugs are harmful and contraindicated.
Development and commercialization of a sensitive blood test for synucleinopathies would address a
major unmet need for selecting appropriate antipsychotic treatments that avoid severe adverse effect.
The proposed work leverages a proprietary procedure NeuroDex developed for isolating EVs from plasma using
immunoaffinity for cell-specific surface markers. Using this approach, the company demonstrated a > 20-fold
increase in signal to noise ratio of NDEs, a degree of specificity that is essential for analyzing aSYN because >
90% of aSYN in plasma does not originate in the brain and is not disease related. Previous efforts to measure
aSYN in unprocessed plasma have not yielded any diagnostic value, but measurement after NDE isolation
provides powerful classification. Leveraging this approach, NeuroDex has developed assays to test aSYN within
and on the surface of neuron-, microglia-, and oligodendrocyte-derived EVs. These assays successfully
distinguished 35 healthy controls, 51 PD patients, and 30 MSA patients with high accuracy. NeuroDex now
proposes to complete the discovery phase (Phase I) and conduct analytical and clinical validation (Phase II).
PHASE I—Aim 1. Identify final biomarkers to be included in the synucleinopathy detection panel. Using
195 samples from healthy individuals and patients with an array of autopsy-confirmed synucleinopathies, we will
assess the performance of different panels of the possible biomarkers to select the combination with the best
performance. Success Metric: ≥ 80% PPV for identifying patients with synucleinopathies and ≥ 90% NPV. Aim
2. Qualify the selected assays. Success Metrics: precision CoV ≤ 20%, linearity across 8-fold dilution range,
and LLQ compatible with clinical samples. Go/No Go Criterion for Progression to Phase II: Completion of the
discovery phase to include a defined set of biomarkers in a panel that a) provides ≥ 90% NPV and b) can be
measured in a robust manner (variability in precision and reproducibility <20%). PHASE II—Aim 1. Analytical
validation of the diagnostic assay. Milestones & Success Metrics: 1) Successful audits for CLIA lab SOP, 2)
analytical data package for FDA breakthrough designation submission. Aim 2. Preliminary clinical validation
of the diagnostic assay in a CLIA-certified lab. We will validate the assays with 700 samples from patients
with dementia with or without synucleinopathies and age-matched controls. Milestones & Success Metrics:
primary: NPV ≥ 90%; secondary: PPV ≥ 80%. Impact—Development and rigorous validation of a novel blood
test for differential diagnosis of dementia with synuclein pathology would produce...

## Key facts

- **NIH application ID:** 10602294
- **Project number:** 1R44NS130864-01
- **Recipient organization:** NEURODEX INC
- **Principal Investigator:** Erez Eitan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $449,999
- **Award type:** 1
- **Project period:** 2022-09-23 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10602294

## Citation

> US National Institutes of Health, RePORTER application 10602294, Development of a Blood-based Test for Identifying Synucleinopathy in Patients with Dementia (1R44NS130864-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10602294. Licensed CC0.

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