Aromha Inc — Department of Health and Human Services STTR Phase II: NIA

Description

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.