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Highly selective detection of tau oligomers in biological fluids for the diagnosis of Alzheimer's Disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42AG058333-01
Agency Tracking Number: R42AG058333
Amount: $217,647.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-04-01
Award End Date (Contract End Date): 2019-03-31
Small Business Information
1302 WAUGH DR STE 842
Houston, TX 77019-3908
United States
DUNS: 012930655
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 BEN VOLLRATH
 (858) 999-4413
 ben@ampriondx.com
Business Contact
 RUSSELL LEBOVITZ
Phone: (281) 802-4776
Email: russ@ampriondx.com
Research Institution
 TEXAS TECH UNIVERSITY HEALTH SCIS CENTER
 
3601 4TH STREET - MS 6271
LUBBOCK, TX 79430-6271
United States

 Nonprofit College or University
Abstract

ABSTRACT
This proposal is for a phase I II fast track project for the STTR program with the main goal to
develop a test for high sensitive detection of tau oligomers in biological fluidswhich could be
used for the biochemical diagnosis of Alzheimerandapos s diseaseADand related tauopathiesAD is
the most common dementia in the elderly population and one of the leading causes of death in
the developed worldOne of the main problems in AD is the lack of an earlysensitive and
objective laboratory diagnosis to identify individuals that will develop the disease before
substantial brain damageCompelling evidences point that the hallmark event in AD is the
misfoldingaggregation and brain accumulation of amyloid betaAand tau proteinsRecent
evidences suggest that Apathology is the primary driving force of the disease initiationbut
this is accomplished by induction of tau hyperphosphorylationmisfolding and aggregationleading to the neurodegenerative cascadeTau aggregation follows a seeding nucleation
mechanism and involves several intermediatesincluding soluble oligomers and protofibrilsRecent evidence has shown that tau oligomers are circulating in biological fluids and these
structures appear to be key for inducing brain degeneration in ADOur working hypothesis is
that detection of misfolded tau oligomers circulating in blood may be the basis for an early
biochemical diagnosis for ADOur approach is to use the functional property of misfolded
oligomers to seed the aggregation of the monomeric protein as a way to detect themFor this
purposewe have developed the protein misfolding cyclic amplificationPMCAwhich
represent a platform technology to detect very small quantities of seeding competent misfolded
oligomeric proteins associated with various protein misfolding diseasesCurrentlyPMCA has
been adapted to detect misfolded prion protein implicated in prion diseases in various biological
fluidsincluding blood and urine and more recently soluble oligomers composed of Aandsynuclein in cerebrospinal fluidCSFof patients affected by AD and Parkinsonandapos s diseaserespectivelyThe major goal of this project is to adapt the PMCA technology for specific and
highly sensitive detection of misfolded tau oligomers in human CSF and blood plasmaperform
studies of specificity and sensitivity using large number of samples coming from patients
affected by AD and other tauopathies as well as to evaluate the utility of tau PMCA for
monitoring disease progressionThe results generated in this project may lead to the first
biochemical test for diagnosis of ADThe studies included in this project will constitute the basis
for regulatory approval of the test that Amprion will commercialize NARRATIVE
Development of a biochemical assay for the sensitiveearly and non invasive diagnosis of
Alzheimerandapos s disease is a top medical priorityessential to permit efficient treatment of this
devastating diseaseThis project proposes to develop the protein misfolding cyclic amplificationPMCAtechnology to detect with high sensitivity and specificity tau oligomers which are
considered the key molecules responsible for neurodegeneration in ADIn this project we have
put together the relevant technical and business expertise and secured the availability to key
samples to permit the successful developmentvalidation and approval of the test

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

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