NIH-funded research NIH-funded research

Biomarker test for early ALS diagnosis using Nano-QuIC detection of misfolded TDP-43

Official title: Biomarker Study in Amyotrophic Lateral Sclerosis (ALS) for Early Detection of Misfolded TDP-43 through Nano-QuIC Assays

Funded at University of Minnesota · NIH-11358045 · Data updated 2026-11-12

A new blood, spinal fluid, or nasal swab test using Nano-QuIC aims to detect misfolded TDP-43 early in people at risk for ALS to speed up diagnosis and treatment.

More Amyotrophic Lateral Sclerosis research and trials

Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionUniversity of Minnesota
NIH-funded
Lab location1 site (Minneapolis, United States)
Project startSeptember 9, 2026
Project endJuly 31, 2029
Funding year2026
Award (this year)$1,782,882
NIH project number1R61NS149366-01
Project IDNIH-11358045 on NIH RePORTER

Who could benefit from this research

Could help

People with ALS or suspected ALS, and healthy controls or individuals with other conditions causing similar symptoms, may participate through sample collection.

Less likely to help

Some individuals with non-ALS conditions or those not providing usable samples may not benefit from this diagnostic test.

What this research studies

This project focuses on developing a simple, reliable test to detect misfolded TDP-43 protein in ALS patients as early as possible. Researchers will first validate the test on brain tissue from people who died of ALS, then apply it to spinal fluid, blood, and nose swabs to see if ALS can be distinguished from healthy people and other conditions. The goal is to create a diagnostic tool that can be used in clinics to shorten the diagnostic delay and enroll patients in trials sooner. The study uses established lab methods to optimize accuracy and reliability across sample types.

Why it matters

Potential benefit: If successful, patients could receive an earlier and more accurate diagnosis, accelerate access to treatments and clinical trials, and reduce the time to appropriate care.

How similar studies have gone: Previous work in ALS biomarkers has shown promise, but this study tests a novel Nano-QuIC approach for multiple sample types and early detection.

Where this research is happening

  • University of Minnesota
    Minneapolis, United States
    Active

Researchers

  • Principal investigator: Walk, David — University of Minnesota
  • Study coordinator: Walk, David

Related research

Other NIH-funded projects on the same topics.

  • Investigating how DNA damage and repair mechanisms are altered in ALS and frontotemporal dementia.

    This study is looking at how problems with DNA repair might contribute to conditions like ALS and frontotemporal dementia, and it’s testing ways to fix these issues in cells from patients to help develop new treatments.

    NIH research Methodist Hospital Research Institute · Houston, United States · NIH-9980670

  • CNM-Au8 Expanded Access for ALS patients across the U.S.

    A wide-access program is testing CNM-Au8, a neuroprotective medicine, for people with ALS across all 50 states.

    NIH research New York University School of Medicine · New York, United States · NIH-11415221

  • Access to CNM-Au8 for people with ALS

    This program offers people with ALS access to CNM-Au8, an experimental oral therapy that aims to protect motor neurons and support cellular energy.

    NIH research New York University School of Medicine · New York, United States · NIH-11405390

  • Engineered regulatory immune cells to protect nerves in ALS

    Engineered regulatory immune cells (CAR Tregs) that seek out misfolded SOD1 and calm inflammation around motor neurons in people with ALS.

    NIH research Celdara Medical, LLC · Lebanon, United States · NIH-11181028

  • Using engineered immune cells to treat ALS

    This study is exploring a new way to help people with ALS by using specially designed immune cells to target harmful proteins in the body, with the hope of reducing inflammation and slowing down the disease.

    NIH research Celdara Medical, LLC · Lebanon, United States · NIH-11128419

  • Understanding ALS Risk in Workers with Certain Occupations

    This project is creating a group of people at higher risk for ALS to learn how their jobs and genes might lead to the disease.

    NIH research University of Michigan at Ann Arbor · Ann Arbor, United States · NIH-11113782

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.