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Digital Accessible Remote Olfactory Mediated Health Assessments for Preclinical AD

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42AG062130-03
Agency Tracking Number: R42AG062130
Amount: $2,468,523.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIA
Solicitation Number: PAS19-317
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-30
Award End Date (Contract End Date): 2023-05-31
Small Business Information
Potomac, MD 20854-4272
United States
DUNS: 118263562
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (301) 466-2328
Business Contact
Phone: (301) 466-2328
Research Institution
BOSTON, MA 02114-2621
United States

 Domestic Nonprofit Research Organization

Project Summary / Abstract
Over 5.8 million Americans are currently affected by Alzheimerandapos;s disease (AD) with an economic burden
estimated at andgt; $270 billion/year in 2020 that is projected to increase at least four fold over the next several
decades. Accurate biomarkers have been developed that demonstrate that AD pathology is present 15 years of
more prior to the onset of memory symptoms. There is converging opinion that the best strategy to develop
disease modifying therapies is to design clinical trials during this asymptomatic, preclinical period. The current
biomarkers that detect individuals in the 15-year preclinical period of AD (prior to the onset of memory
symptoms) have limitations. They are largely radiological indicators, which are expensive and require the
subject to travel to a remote location or are invasive or expensive. To address this critical unmet medical need,
we developed and tested the AROMHA web-based app that conducts the odor tests needed for the POEM
algorithm in our Phase I STTR grant. The POEM algorithm sets personalized thresholds to define selective
odor memory loss in cognitively normal elderly individual by normalizing each individualandapos;s olfactory function
using odor discrimination and odor identification test. Clinically normal elderly individuals with a selective odor
memory deficit are enriched in the 3 key AD risk factors: ApoE4, neurodegeneration in a key memory and
olfactory processing area of the brain, a significant decline in cognitive function over time. Recently, this
selective odor memory loss was found to increase risk of progression to MCI over the next 4 years with a HR andgt;
3.3. In order to fully realize the potential of the POEM algorithm, in this Phase II application we seek to expand
our AROMHA products by creating a digital olfactory battery that couples with the POEM algorithm, with the
ultimate goal that this can be self administered independently at home. To accomplish this goal, we will
develop standalone apps in the iOS and Android ecosystems and continue working with Scentovation, a
company taking an innovative approach to the design and manufacturing of odor delivery devices, that are
reusable or and International Flavors and Fragrances (IFF) who has developed smell cards that are mailable
and disposable. The mobile app will organize the subjectandapos;s experience with instructions and cues, will collect
the response data generated in response to the tests, and will send it securely to a central location. In addition,
proprietary naturalistic odors developed by IFF will be incorporated into this battery to improve the perceptual
salience of odors and performance across different cultures and continents. Following the development of
these new products, we will seek to field test them in both clinical and home settings. Used alone or together
with other non-invasive measures that probe function of different brain regions, a remote test to identify
cognitively normal people harboring AD pathology and at risk of developing clinical AD is an essential step to
developing and clinically managing therapies that will impact the growing epidemic of AD.Project Narrative
Detecting clinically normal elderly individuals with AD pathology and following their disease progression in a
non-invasive, affordable manner is a critical step to developing and monitoring disease modifying therapies.
We have incorporated the POEM (Percepts of Odor Episodic Memory) battery and algorithm into a web-based
app to identify cognitively healthy elderly individuals at risk for progression to MCI. To seek further validation of
this promising methodology, we propose to develop digital AROMHA standalone apps in the iOS and Android
ecosystems to conduct this olfactory battery for remote assessment of the POEM algorithm using novel odor
diffusers and disposable scent cards to emit naturalistic odors.

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

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