# Development and Validation of a Quantitative Diagnostic Biomarker for Silent Brain Injury

> **NIH NIH R43** · SAGE CEREBROVASCULAR DIAGNOSTICS, INC. · 2024 · $307,538

## Abstract

PROJECT SUMMARY
Alzheimer's disease (AD) is among the leading causes of death and disability worldwide with the number of
patients in the US estimated to reach 16 million by 2050, associated with an annual cost of care projected to
reach $1.1 trillion. Vascular contributions to dementia contribute to the pathogenesis of AD and directly cause
vascular dementia, the primary AD-related dementia (ADRD). Presently, vascular dementia cannot be reliably
diagnosed without costly MRI studies and detailed imaging analysis. There is a pressing need to develop better
diagnostic tools, particularly those that target the vascular contributions to dementia in order to value the
contribution of vascular injury in establishing a dementia diagnosis. In addition, improving the ability to
discriminate between AD and vascular dementia can directly inform prognosis and treatment plans. The goal of
the proposed studies is to develop and validate a novel, minimally invasive diagnostic assay to discriminate AD
from vascular dementia. Sage Cerebrovascular Diagnostics has developed a panel-based diagnostic assay
incorporating six interconnected inflammatory molecules that preliminary data indicate can reliably detect the
presence of cerebrovascular injury. This panel-based assay to detect silent cerebrovascular injury using a
capture-detection immunoassay on the Luminex platform is technically reliable and reproducible across
populations using a log-normalized, population mean-adjusted composite scoring approach. These diagnostic
biomarkers for silent brain injury (SageSignalTM at-home test assay) are increased in individuals with
cerebrovascular risk factors for dementia including hypertension, diabetes, and stroke. Further, SageSignalTM
at-home test assay results are sensitive for Magnetic Resonance Imaging (MRI) metrics of both early and late
cerebrovascular damage as demonstrated on MRI. With extensive data indicating a link between inflammation
and cerebrovascular injury, the SageSignalTM at-home test assay is ready for diagnostic validation as a novel
biomarker with utility in the diagnosis of AD and ADRDs. Here, we propose studies to validate the robustness of
the SageSignalTM at-home test assay in the CLIA lab environment with establishment of pre-analytic, analytic,
and post-analytic performance characteristics (Aim 1), identify the optimal at-home collection methodology (Aim
2), and determine the sensitivity and specificity of the assay for vascular brain injury using clear pre-specific
milestones to judge diagnostic accuracy (Aim 3). The proposed project will demonstrate that SageSignalTM at-
home test can function as a sensitive and specific innovative diagnostic tool to improve the detection and
stratification of individuals with cognitive impairment due to vascular damage to the brain. At the successful
conclusion of this Phase I SBIR, we will have a novel and minimally invasive biomarker test ready for subsequent
clinical prospective validation to identify i...

## Key facts

- **NIH application ID:** 11007524
- **Project number:** 1R43NS139780-01
- **Recipient organization:** SAGE CEREBROVASCULAR DIAGNOSTICS, INC.
- **Principal Investigator:** Sadaf Ebrahimzadeh Pustchi
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $307,538
- **Award type:** 1
- **Project period:** 2024-09-04 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007524

## Citation

> US National Institutes of Health, RePORTER application 11007524, Development and Validation of a Quantitative Diagnostic Biomarker for Silent Brain Injury (1R43NS139780-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11007524. Licensed CC0.

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