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Development and validation of an alpha-synuclein Seed Amplification Assay using peripheral bodily fluids of patients affected by Parkinson's disease and Dementia with Lewy bodies

Award Number: R61NS151436
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: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Development and validation of an alpha-synuclein Seed Amplification Assay using peripheral bodily fluids of patients affected by Parkinson's disease and Dementia with Lewy bodies - ABSTRACT One of the greatest obstacles for developing a disease-modifying therapy for various neurodegenerative synucleinopathies, including Parkinson's disease (PD), dementia with Lewy bodies (DLB), PD dementia (PDD) and multiple system atrophy (MSA), is the lack of early and accurate diagnosis. Currently, disease is diagnosed by the onset of the clinical symptoms with the help of some neuroimaging tests, however at the time diagnosis is reached, up to 70% of dopaminergic neurons in the substantia nigra are already lost. Thus, there is a pressing unmet need to identify biomarkers that can serve for early and non-invasive biochemical diagnosis of these diseases. Recently, we invented and developed a highly sensitive and specific assay (termed seed amplification assay or SAA) to detect alpha-synuclein (αSyn) aggregates in patients affected by PD, DLB and MSA, as well as prodromal version of these diseases (1-5). Currently, αSyn-SAA is well-validated to detect αSyn pathology in CSF samples. However, lumbar puncture is an invasive procedure that precludes the massive use of the test, especially at the preclinical stage of the disease. The challenge to detect αSyn aggregates in biological fluids other than CSF is their low quantity and the interference from other components present in the fluids. The main context of use (COU) for this project is the implementation and development of an assay to detect αSyn pathology in blood or urine samples that can be used to help disease diagnosis as well as for early and routine screening of individuals exhibiting some abnormalities that are considered prodromal versions of synucleinopathies. In this project we will follow up our promising preliminary results to develop conditions to adapt the αSyn-SAA technology for detection of αSyn aggregates in non-invasively collected biological fluids, including blood and urine, verify its robustness and validate its sensitivity and specificity in groups of PD patients and controls, as well as individual at prodromal stages of the disease. During the R61 phase, we will complete assay development for detection of αSyn seeds in blood/urine and perform analytical validation studies of the blood/urine detection assay. In the R33 phase, we will estimate clinical sensitivity and specificity for the context of use and assess the usefulness of αSyn-SAA for preclinical detection of αSyn pathology in these easily collectable biological fluids.


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 = $722,153 )
2026	2026	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST FL 9	HOUSTON	TX	77030	HARRIS	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/31/2026	NEW	$722,153
														Subtotal = $722,153

Grand Total All Awards = $722,153

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Development and validation of an alpha-synuclein Seed Amplification Assay using peripheral bodily fluids of patients affected by Parkinson's disease and Dementia with Lewy bodies

Award Number: R61NS151436

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: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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