# A Novel Blood Test for Early Diagnosis of Frontotemporal Lobar Degeneration

> **NIH NIH R43** · VIRTICI, LLC · 2024 · $700,000

## Abstract

Project Summary
Our objective is to develop a blood-based diagnostic for early diagnosis and classification of Frontotemporal
Lobar Degeneration (FTD).
FTD is a common presenile dementia that afflicts an estimated 60,000 patients in the US with most cases
occurring between the ages of 45 and 641. For patients under 65, FTD is the second most prevalent subtype of
dementia after Alzheimer’s Disease (AD). FTD is a heterogeneous neurodegenerative disease characterized
by progressive loss of behavior and language skills associated with degeneration of the frontal and anterior
lobes1. Currently, an accurate diagnosis of FTD takes approximately 3.6 years1. This is mainly because
diagnosis of FTD is costly and complex, involving neurological tests, brain imaging, a full set of blood work (to
rule out other causes for the symptoms), and sometimes a lumbar puncture plus electrophysiologic testing. As
a result, up to two thirds of patients fail to complete testing, contributing to the ~58% of all FTD patients
remaining undiagnosed2.
In AD, studies reveal that various aggregated protein variants, commonly found in the brains of patients, can
also be detected in the blood, showing promise for the development of a blood-based diagnostic. So far,
studies have focused on single markers over a multiparameter approach, with no consensus as to which
marker is superior3-9. Currently, there are no known biomarker assays available to diagnose FTD. It is our
hypothesis that a simple blood test identifying distinct variant oligomeric biomarkers will enable more accurate
diagnosis of FTD.
Recently, our project team applied novel biopanning techniques to identify single chain antibody variable
domain antibodies (scFvs) that bind to disease-specific variants of four key neuronal proteins implicated in FTD
and related dementias: Tau, TDP-43, Aβ, and α-syn. Our novel scFvs react only to the variants found in brain
and plasma samples from FTD patients, but not cognitively normal controls10-12. More interestingly, a subgroup
of antibodies is able to distinguish the two major FTD subtypes, FTD-Tau and FTD-TDP. Our preliminary
results suggest that a blood biomarker approach may prove to be an extremely valuable tool to diagnose FTD
earlier in disease progression, and potentially identify FTD subtypes.
Building from this innovative work, this proposal is designed to develop a blood-based diagnostic for early
diagnosis and classification FTD. The specific aims are to: 1) develop a low-volume, antibody-based assay for
quantitation of plasma protein variants; 2) identify the optimal biomarker set for early diagnosis and
stratification of FTD subtypes; 3) measure the assay performance in a blinded study of ante-mortem FTD
patient samples. A novel blood test for early diagnosis and classification of FTD would provide a significant
advancement for a clear unmet medical need.

## Key facts

- **NIH application ID:** 11005947
- **Project number:** 1R43NS139747-01
- **Recipient organization:** VIRTICI, LLC
- **Principal Investigator:** Neil A Fanger
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $700,000
- **Award type:** 1
- **Project period:** 2024-08-15 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11005947

## Citation

> US National Institutes of Health, RePORTER application 11005947, A Novel Blood Test for Early Diagnosis of Frontotemporal Lobar Degeneration (1R43NS139747-01). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/11005947. Licensed CC0.

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