New Paper Published in Alzheimer’s; Dementia: The Journal of the Alzheimer’s Association, Demonstrates Correlation Between the Presence of Misfolded α-Synuclein and Clinical Presentations of Alzheimer’s Disease

SAN DIEGO, February 9, 2024Amprion is pleased to be affiliated with a new scientific paper published in Alzheimer’s & Dementia, entitled “Investigating alpha-synuclein co-pathology in Alzheimer’s disease by means of cerebrospinal fluid alpha-synuclein seed amplification assay,” led by University of Perugia Professor, Dr. Lucilla Parnetti and Amprion Director of Research and Development, Dr. Luis Concha-Marambio.

In this study, the α-Synuclein Seed Amplification Assay (αS-SAA) developed by Amprion, commercially known as the SYNTap® Biomarker Test, was performed on cerebrospinal fluid (CSF) samples from 240 Alzheimer’s disease (AD) patients. These patients were extensively characterized by Dr. Parnetti’s team, with CSF samples collected in preclinical, prodromal, and dementia stages. The goal was to determine the prevalence of misfolded α-synuclein in this population and evaluate correlation with clinical presentations, such as neuropsychiatric symptoms or cognition.

Misfolded α-synuclein, which is evidenced by αS-SAA positivity, was observed in 30% of AD patients, and closely matched the 33% prevalence of Lewy body pathology determined at autopsy1. Moreover, SAA positivity was associated with cognitive decline, visual-spatial impairment, behavioral disturbances, and a worse clinical outcome. These data suggest that misfolded α-synuclein plays an active role in the clinical presentation of AD.

“The results are very encouraging as they show how underlying synuclein pathology can be detected by αS-SAA during life at all stages of AD,” said Dr. Luis Concha-Marambio, Director of Research and Development at Amprion. “Given the number of people living with AD around the world, our results suggest that AD might be the most prevalent synucleinopathy, effectively making co-pathology the norm rather than the exception.

“In the near future, identifying whether people carry both AD and synucleinopathy in the earliest clinical phases will be mandatory, as it will help determine what precision treatment should be prescribed,” said Dr. Lucilla Parnetti, Professor at the University of Perugia. “The ability to timely halt all the different causes of neurodegeneration, as opposed to only one of them, seems to represent the most promising strategy in the fight against AD and related neurodegenerative disorders.”

The ability of αS-SAA to detect underlying α-synuclein pathology during life has already catalyzed major changes in the field of neurodegeneration, including new proposals to define diseases like Parkinson’s disease (PD) and dementia with Lewy bodies (DLB) based on biomarkers rather than clinical syndromes. This underlines the importance of having a well-controlled, clinically validated tool like the SYNTap® Biomarker Test to determine the presence of misfolded α-synuclein in living patients.

To access the full paper in Alzheimer’s & Dementia, please click here.

About SYNTap®:
Amprion’s SYNTap Biomarker Test is a first-in-class-qualitative Laboratory Developed Test (LDT) and the only seed amplification assay available to aid the diagnosis of synucleinopathies such as Parkinson’s Disease (PD), Lewy Body Dementia (LBD/DLB), and Alzheimer’s Disease (AD) with Lewy Body variant. The U.S. Food and Drug Administration (FDA) granted Amprion a Breakthrough Device Designation in 2019 for use of the test as an aid in the diagnosis of PD. SYNTap became commercially available in 2021.

About Amprion:
Amprion is a global leader in the advancement of neurodegenerative disorder diagnosis through seed amplification testing. As the global population ages, Amprion aims to accelerate precision medicine for neurodegenerative disorders by helping biopharma partners identify new drug candidates and underlying pathologies. The amplification testing methodology was originally developed by Claudio Soto, PhD, Amprion’s Co- Founder and has been further enhanced and validated by Amprion’s in-house scientific team. Amprion currently holds multiple U.S. and International patents for SAA methodology and strives to launch more biomarker tests to detect a wide range of early-stage neurodegenerative disorders.

Please Note: Important Billing Info

To improve patient access to the SYNTap® Biomarker CSF Test, Amprion offers the following billing options:

  • List price of $1500, with courtesy billing for both Medicare and private insurance.
  • An affordable self-pay price of $995 (patients may qualify for financial assistance and/or interest-free payment options).
  • Prices are effective as of January 1, 2024, and are subject to change.

Please note: Amprion is a Medicare participating provider, however, the SYNTap test does not currently have Medicare coverage determination. Also, Amprion is not yet in network with most insurers.

The SYNTap Biomarker CSF Test has been issued a dedicated CPT® PLA code to be used when billing: 0393U.

For additional information, please visit our billing page.