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Blood based diagnostics for Alzheimer s Disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42AG049562-02
Agency Tracking Number: R42AG049562
Amount: $1,069,735.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PA14-072
Timeline
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-06-01
Award End Date (Contract End Date): 2019-05-31
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@benvollrath.com
Business Contact
 RUSSELL LEBOVITZ
Phone: (281) 802-4776
Email: rlebovitz@ampriondx.com
Research Institution
 UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
 
7000 FANNIN STREET, UCT 1000
HOUSTON, TX 77030-5400
United States

 Nonprofit College or University
Abstract

DESCRIPTION provided by applicant This proposal is for a phase I II fast track project for the STTR program with the main goal to develop a blood test for Alzheimerandapos s disease AD diagnosis AD is the most common dementia in the elderly population and one of the leading causes of death in the developed world One of the main problems in AD is the lack of an early sensitive and objective laboratory diagnosis to identify individuals that will develop the disease before substantial brain damage Compelling evidences point that the hallmark event in AD is the misfolding aggregation and brain accumulation of amyloid beta A protein A aggregation follows a seeding nucleation mechanism and involves several intermediates including soluble oligomers and protofibrils Recent evidence has shown that A oligomers are circulating in biological fluids and these structures appear to be key for inducing brain degeneration in AD Our working hypothesis is that detection of misfolded A oligomers circulating in blood may be the basis for an early biochemical diagnosis for AD Our approach is to use the functional property of misfolded oligomers of being capable to catalyze the polymerization of the monomeric protein as a way to detect them We have recently invented the protein misfolding cyclic amplification PMCA which represent a platform technology to detect very small quantities of seeding competent misfolded oligomeric proteins associated with various protein misfolding diseases Currently PMCA has been adapted to detect misfolded prion protein implicated in prion diseases in various biological fluids including blood and urine and more recently soluble A oligomers in cerebrospinal fluid of AD patients The major goal of this project is to adapt the PMCA technology for specific and highly sensitive detection of misfolded A oligomers in human blood perform studies of specificity and sensitivity using large number of samples and evaluate the utility of A PMCA for pre clinical identification of people in the way to develop AD The results generated in this project may lead to the first biochemical test for blood based diagnosis of AD The studies included in this project will constitute the basis for regulatory approval of the test that Amprion will commercialize PUBLIC HEALTH RELEVANCE Development of a blood based biochemical assay for the sensitive early and non invasive diagnosis of Alzheimerandapos s disease is a top medical priority essential to permit efficient treatment of this devastating disease This project proposes to develop the protein misfolding cyclic amplification PMCA technology to detect with high sensitivity and specificity amyloid beta oligomers which are considered the key molecules responsible for neurodegeneration in AD In this project we have put together the relevant technical and business expertise and secured the availability to key samples to permit the successful development validation and approval of the test

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

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