# A Novel Multiparameter Blood Test for Early Detection of Alzheimer's Disease

> **NIH NIH R43** · VIRTICI, LLC · 2022 · $73,171

## Abstract

Project Summary
Our objective is to develop a blood-based diagnostic for Pre-symptomatic detection of Alzheimer's disease
(AD) based on a Multiparameter Profiling (PreAMP).
Currently there are over 18 million cases of AD worldwide, with the number of cases expected to nearly double
over the next 15 years. In the US alone, total economic costs are estimated at nearly $200 billion per year1.
Diagnosis is complex, costly and time-consuming. In part because of the lack of diagnostic tools and because
AD represents a continuum of neurodegenerative disorders that share overlapping symptoms and protein
pathologies. For these reasons, ~58% of dementia is thought to be undiagnosed altogether, which result that
many patients do not receive adequate, timely care or treatment2. Recent work has revealed that forms of the
aggregated proteins commonly found in the brains of AD patients can also be detected in the blood, showing
promise for the development of a blood-based diagnostic. So far, however, different studies have emphasized
single markers over a multiparameter approach, with no consensus as to which marker is superior3-9.
Therefore, a multiparameter biomarker assay may prove to be extremely valuable for early diagnosis of a
diverse range of patients against a continuum of dementias.
The vast majority of biomarker efforts have focused on detection of non-toxic variants rather than the actual
toxic aggregated protein species involved in neurodegeneration. Recently, our project team has developed
novel biopanning technologies that enabled us to generate single chain antibody variable domain antibodies
(scFvs) that bind to disease-specific variants of four key neuronal proteins implicated in AD and Related
Dementias (ADRD): tau, Aβ, TDP-43, and α-syn. Our scFvs react only to the variants found in brain and
plasma samples from ADRD patients but not cognitively normal controls10-12. Levels of Aβ and TDP-43
oligomers recognized by four of our scFvs were significantly elevated years before an initial diagnosis of mild
cognitive impairment (MCI)9. During disease progression, we found that biomarker profiles change, so our
antibody-based diagnostic could also be used to stage progression of AD from pre-symptomatic through late
stage, permitting clinical stratification of patients to support experimental therapy decision-making for ADRD9.
Building from this work, this proposal is designed to develop a blood-based diagnostic for AD called PreAMP.
The specific aims are to: 1) develop a low-volume, multiplex antibody assay for quantitation of plasma protein
variants. 2) determine the optimal biomarker set for pre-symptomatic diagnosis of AD, 3) validate the assay
performance in a blinded retrospective study of longitudinal AD patient samples.

## Key facts

- **NIH application ID:** 10683848
- **Project number:** 3R43AG076091-02S1
- **Recipient organization:** VIRTICI, LLC
- **Principal Investigator:** Neil A Fanger
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $73,171
- **Award type:** 3
- **Project period:** 2021-09-30 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10683848

## Citation

> US National Institutes of Health, RePORTER application 10683848, A Novel Multiparameter Blood Test for Early Detection of Alzheimer's Disease (3R43AG076091-02S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10683848. Licensed CC0.

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