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Blinded Comparison of Different Alpha-Synuclein Seeding Assays as Cutaneous Biomarkers of Lewy Body Dementias

Award Number: R01NS118669
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: 09/15/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Blinded Comparison of Different Alpha-Synuclein Seeding Assays as Cutaneous Biomarkers of Lewy Body Dementias - Abstract With increasing longevity in our population, dementia is widely recognized as an impending public health crisis. Lewy body dementia (LBD), encompassing dementia with Lewy bodies (DLB) and Parkinson disease dementia (PDD), is the second most common cause. LBD is characterized by abnormal aggregation and accumulation of a protein, α-synuclein (aSyn). PDD and DLB are clinically separated only by the relative timing of the onset of parkinsonism and dementia. At present, advances in the treatment of these conditions are critically hampered by the lack of non-invasive, inexpensive biomarkers that can provide accurate diagnostic and prognostic information. This situation may soon be resolved, as in recent years it has become apparent, through our own studies and those of others, that biopsies of peripheral tissue sites can detect diagnostically significant aSyn. Our project will assess aSyn in punch biopsies of the skin. Our preliminary data from new “seeding assay” methods including real-time quaking-induced conversion (RT-QuIC) and protein misfolding cyclic amplification (PMCA), from autopsy-confirmed LBD subjects, indicate high sensitivity and specificity for predicting the presence of aSyn in the skin of affected subjects. Further work is necessary to confirm these results in living subjects with these conditions, which is the objective of this proposed project. We will biopsy, twice during a four year period, 90 subjects with aSyn disease, 30 each with PD, PDD and DLB, as well as 30 normal control subjects. Two independent laboratories will blindly perform separately-developed seeding assays, rigorously testing the interlaboratory reliability and providing estimates of aSyn density change over time. The seeding assay results will be compared with those obtained by the current gold-standard biopsy method, immunohistochemistry (IHC). All subjects will receive cognitive and movement disorder assessments at two timepoints in this four year project, enabling comparisons of assay measures with cognitive and motor decline rates. Many of the subjects will be enrolled in the Arizona Study of Aging and Neurodegenerative Disorders (AZSAND), a longitudinal clinicopathological study with an autopsy rate exceeding 90%. This will allow, in a substantial subset, eventual neuropathological confirmation of the molecular cause of parkinsonism and dementia in each subject.


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: 2025 ( Subtotal = $0 )
2025	2024	BANNER HEALTH	2901 N CENTRAL AVE STE 160	PHOENIX	AZ	85012	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	9/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $571,411 )
2024	2024	BANNER HEALTH	2901 N CENTRAL AVE STE 160	PHOENIX	AZ	85012	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	8/12/2024	NON-COMPETING CONTINUATION	$571,411
														Subtotal = $571,411

Issue Date FY: 2023 ( Subtotal = $569,916 )
2023	2023	BANNER HEALTH	2901 N CENTRAL AVE	PHOENIX	AZ	85012	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/2/2023	NON-COMPETING CONTINUATION	$569,916
														Subtotal = $569,916

Issue Date FY: 2022 ( Subtotal = $572,495 )
2022	2022	BANNER HEALTH	2901 N CENTRAL AVE	PHOENIX	AZ	85012	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/1/2022	NON-COMPETING CONTINUATION	$572,495
														Subtotal = $572,495

Issue Date FY: 2021 ( Subtotal = $621,264 )
2021	2021	BANNER HEALTH	2901 N CENTRAL AVE	PHOENIX	AZ	85012	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	9/6/2021	NEW	$0
2021	2021	BANNER HEALTH	2901 N CENTRAL AVE	PHOENIX	AZ	85012	MARICOPA	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	7/29/2021	NEW	$621,264
														Subtotal = $621,264

Grand Total All Awards = $2,335,086

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Blinded Comparison of Different Alpha-Synuclein Seeding Assays as Cutaneous Biomarkers of Lewy Body Dementias

Award Number: R01NS118669

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: 09/15/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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