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Screening for Alzheimer's Disease Based on Raman Spectroscopy of Blood

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AG078073-01A1
Agency Tracking Number: R41AG078073
Amount: $306,974.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-30
Award End Date (Contract End Date): 2023-08-31
Small Business Information
Glenmont, NY 12077-3318
United States
DUNS: 117432627
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (518) 591-8863
Business Contact
Phone: (617) 453-8230
Research Institution
ALBANY, NY 12222-0001
United States

 Nonprofit College or University

Abstract -
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that affects an estimated 6.2 million
Americans and the 6th leading cause of death in the U.S. AD is progressive and incurable; dementia symptoms
gradually worsen over a number of years. In its early stages, memory loss is mild, but in late-stage AD, individuals
lose the ability to carry on a conversation and respond to their environment. AD is a devastating condition that
creates vast emotional, financial, and physical challenges for the person and their family. In AD, pathological
changes may arise up to 20 years before the onset of dementia, providing a unique window of opportunity
for interventions aimed at preserving cognitive health and delaying disease progression. However, there is
currently no diagnostic tool that can be widely applied for the detection of preclinical AD. When potentially
effective therapies are initiated late in the underlying disease pathology process (i.e., after cognitive decline is
apparent), the true impact of prevention is not achieved. In response to the critical need for an accessible
diagnostic tool for early and preclinical AD, Early Alzheimer’s Diagnostics proposes to develop a screening
technology based on Raman Spectroscopy combined with machine learning (ML) models trained to
detect spectral signature changes based on the contribution of multiple biomarkers found in the blood.
The proposed technology has the potential to greatly improve outcomes by allowing patients to identify early
signs of AD, and therefore start preventive interventions and active monitoring of disease progression, delaying
the onset of dementia, and preserving brain health for longer. Such a tool would also have significant utility in
clinical trials for critically needed new AD therapies, facilitating recruitment and selection of healthy volunteers
and AD patients at various stages of disease progression. Preliminary results show that the approach can
differentiate the biochemical composition of blood from patients at different stages of AD from healthy controls.
The team has also developed a novel method using automated mapping of solid samples to detect ultra-small
amounts of biomarkers by preventing them from leaving a small volume interrogated by the focused laser light
during spectral acquisition. This Phase I project will provide de-risk key aspects in the process of adapting the
technology into a clinical commercial application and provide proof-of-feasibility via a blind test. The Specific
Aims of this STTR project are: 1) Optimize a scalable, rapid methodology for obtaining and analyzing Raman
spectral data from blood serum; 2) Develop ML algorithm approaches for analyzing Raman spectral data; and
3) Validate the Raman spectroscopy-based approach in a blind test. Successful completion of proposed research
will position Early Alzheimer’s Diagnostics to perform initial clinical trials in Phase II, and advance discussions
with potential industry partners to establish partnerships to develop the proposed approach into either a stand-
alone diagnostic test or possible companion diagnostic.Narrative -
Alzheimer’s disease is a progressive, incurable neurodegenerative disorder, and its pathology begins many
years before symptoms emerge, underscoring the importance of early diagnostics. Early Alzheimer’s Diagnostics
proposes to develop a Raman spectroscopy-based diagnostic tool for Alzheimer’s disease, based on a minimally
invasive blood test. Early Alzheimer’s Diagnostics has the potential to dramatically improve outcomes by allowing
patients to start treatment with disease-modifying therapies years earlier than what is currently possible.

* Information listed above is at the time of submission. *

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