# Plasma Assays for NPTX2 in Alzheimer's Disease

> **NIH NIH R43** · COGNEXT DIAGNOSTICS, LLC · 2021 · $499,999

## Abstract

Abstract
CogNext is submitting this proposal in response to PAR-19-316 to develop novel diagnostics for
Alzheimer’s disease (AD). AD represents a major medical challenge and precedent from failed
clinical trials with amyloid reducing therapies highlights the need for biomarkers that can predict
progression of cognitive failure, and that are diagnostic and prognostic at the earliest stage of
disease. CogNext Diagnostics was founded by neuroscientists from Johns Hopkins whose
studies of the cellular and molecular basis of memory identified CSF NPTX2 to be a biomarker
with extraordinary diagnostic performance. NPTX2 plays an essential role in the physiology of
memory and is markedly decreased in brain and CSF of human subjects with AD. CSF NPTX2
correlates with cognitive performance in aged, non-demented individuals, distinguishes controls
from MCI as well as Aß or tau, enhances the diagnostic performance of tau, and in two
independent studies predicts progression of disease in MCI/early AD. A CSF assay for NPTX2
has been awarded patent protection and CogNext has an option for exclusive license. Here,
CogNext seeks SBIR support to test the diagnostic performance of a new assay that detects
NPTX2 in plasma. The assay specifically detects NPTX2 that is in close physical proximity to
co-functional proteins and provides a novel indicator of NPTX2-dependent brain physiology that
distinguishes individuals with MCI/AD from age-matched controls. In Aim 1, CogNext will work
with a biotech partner to measure plasma NPTX2 in archived biospecimens collected as part of
phase 2 and phase 3 clinical trials of an amyloid reducing therapy. Individuals selected for the
phase 3 trail were assessed to be prodromal to early onset AD and are representative of future
clinical trials that will seek to start therapy before the onset of manifest AD. CogNext and
Biopharm partner will determine if plasma NPTX2 alone or in combination with extensive
existing measures including CSF Aß, tau, PET-amyloid, and neuropsychiatic testing predicts
progression. A plasma assay that could match the diagnostic performance of CSF NPTX2 has
the potential to transform clinical trial design. Aim 2 will address the need for high quality
monoclonal antibodies (mAbs) that specifically react with NPTX2 and co-functional proteins and
that can be used to develop commercializable assays. Rabbit mAbs will be generated using
state of the art B-cell selection and validated for specificity and utility for NPTX2 assays in CSF
and plasma. CogNext will work with business partners in a direct-to-industry approach that
offers that fastest path to commercialization and contribution to AD research.

## Key facts

- **NIH application ID:** 10325347
- **Project number:** 1R43AG074773-01
- **Recipient organization:** COGNEXT DIAGNOSTICS, LLC
- **Principal Investigator:** PAUL F WORLEY
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $499,999
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325347

## Citation

> US National Institutes of Health, RePORTER application 10325347, Plasma Assays for NPTX2 in Alzheimer's Disease (1R43AG074773-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10325347. Licensed CC0.

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