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Development of an ophthalmic diagnostic probe for neurodegenerativedisorders

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AG050454-02
Agency Tracking Number: R44AG050454
Amount: $1,859,082.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA15-269
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-30
Award End Date (Contract End Date): 2018-05-31
Small Business Information
San Diego, CA 92121-1126
United States
DUNS: 079331368
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (310) 926-9930
Business Contact
Phone: (508) 662-0904
Research Institution

Project Summary
Deposition of amyloid plaques in the brain represents a universal feature Alzheimer s disease pathology and
precedes clinical symptoms by several years Currently diagnosis of amyloid associated dementias in
individuals showing symptoms of cognitive decline is extremely difficult requiring multiple modes of testing over
months to years Early pre symptomatic diagnosis is even more challenging if not impossible with currently
available technology A non invasive method for diagnosing Alzheimer s disease is greatly needed
We will further evaluate the use of AMDX a novel fluorescent probe that can label amyloids in tissue
as a diagnostic for Alzheimer s disease AMDX has been shown to fluorescently label AD related deposits
in vivo Importantly this probe has also been shown to effectively image amyloid deposits in the retina of AD
mice following both topical and intravenous dosing The properties of AMDX are ideal for its development
as a topical diagnostic probe for AD The studies outlined in this proposal advance AMDX to the Pre IND
stage The synthesis of AMDX will be optimized through dedicated process development activities A
formulation effective for topical administration in humans will be developed along with in vivo evaluation of
diagnostic efficacy in two species of animals Further the retinal images obtained throughout formulation
development will be utilized to develop a method to quantify the number size and intensity of amyloid deposits
Together the aims of this proposal will result in an optimized diagnostic product capable of imaging AD in the
retina The diagnostic product will be advanced to the point of being ready for IND enabling Toxicology studies Project Narrative
Alzheimer s disease is characterized by the deposition of insoluble protein aggregates in the brain that are
referred to as amyloids Recently these amyloids have been identified in retinal tissue in diseased individuals
The proposed research aims advance a topical diagnostic to image amyloid deposits

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

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