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

Award Number: R61NS149366
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/09/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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Biomarker Study in Amyotrophic Lateral Sclerosis (ALS) for Early Detection of Misfolded TDP-43 through Nano-QuIC Assays - Project Summary Amyotrophic Lateral Sclerosis (ALS) is a neurological condition that causes progressive weakness, disability, and death. On average, people wait 12 months from the time they develop symptoms until they are diagnosed. Because survival in ALS is only 3-5 years on average, many people do not receive the diagnosis until well into the disease process. This “diagnostic delay” results in delays in treatment and research. As better treatments are developed for ALS, it will become all the more crucial to diagnose the disease early and more easily. The misfolded TDP-43 protein has emerged as a key feature in most patients with ALS, thus, early detection of misfolded TDP-43 can accelerate diagnosis, treatment, and enrollment in clinical research. This project will test whether a new diagnostic process called Nano-QuIC can diagnose ALS early and easily, and whether it can also be used to confirm ALS when the diagnosis remains unclear after standard testing. We will begin by confirming that we can identify this protein reliably in brain tissue from people who died due to ALS, and in spinal fluid in people with ALS. We will also test blood and, if necessary, swabs from the nose, to see if we can distinguish people with ALS from healthy individuals and from people with other conditions that cause similar symptoms. Using established tools in our laboratory, we will optimize the test to make it as reliable as possible. This is a two stage project. If we are successful at developing these diagnostic tests in the first phase, we will proceed to larger-scale testing in a new set of samples from people recently evaluated for symptoms of ALS as well, again, as healthy individuals. The results of this second stage will determine whether these tests are ready for broader testing and possible approval as a routine clinical test. This research is significant as it seeks to develop a simple, affordable way to determine whether a person may have ALS to accelerate diagnosis both of ALS and of other conditions that may mimic ALS. By doing so, we hope to enhance the potential benefits of existing and experimental therapeutics for ALS patients, providing a greater opportunity for successful treatment outcomes. Our project has the potential to make a substantial impact on clinical trial design and patient outcomes in ALS.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,782,882 )
2026	2026	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/9/2026	NEW	$1,782,882
														Subtotal = $1,782,882

Grand Total All Awards = $1,782,882

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

Award Number: R61NS149366

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/09/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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