# Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)

> **NIH NIH R44** · EVON MEDICS, LLC · 2022 · $50,000

## Abstract

ABSTRACT
Evon Medics, LLC proposes to evaluate and optimize the portable, home-based product – the Computerized
Olfactory Training Program (COT) – as a disease modifying intervention for prevention of progressive cognitive
decline and progressive dementia in prodromal and early Alzheimer's Disease (AD). The COT uses validated
neuroprotective olfactory stimulants to intensely engage the primary and secondary olfactory cortices, with
stimulation parameters that overcome olfactory habituation, paired with computerized olfactory cognitive
training tasks that synergistically enhance the same brain regions; with the goal of increasing structural and
functional resilience to AD progression. This innovative solution, despite its promising disease modifying
therapeutic properties and promising clinical trials results, would not be FDA cleared and available to the
billions of patients suffering for the debilitating neurological diseases, which the innovation promises to treat,
without a concrete, comprehensive and fool-proof regulatory strategy, implementation, and execution. Evon
Medics, based on recommendations from its TABA needs assessment consultations, as well as
recommendations from a number of industry luminaries and consultants has decided to revisit its regulatory
strategy and hire a reputable and highly recommended regulatory consulting company to ensure a successful
FDA clearance and market launch.
The regulatory consulting company hired to drive the mission for a successful FDA clearance has vast
experience in taking drugs, biologics, and devices through successful regulatory process to FDA clearance and
would be involved in re-defining the Evon Medics regulatory strategy for the COT and other relative Evon
Medics products that are a derivative of its patented Olfactory Treatment Delivery Systems (OTDS). The
services would also include preparation and eCTD re-submissions of IND’s and liaison with the FDA to ensure
clearance, continuous regulatory consultation services throughout the duration of the study, annual IND report
preparation and submissions, and execution of regulatory strategies to ensure a successful FDA clearance.
Highly experienced regulatory consultants have been assigned to lead and execute on this project and the
company has assured Evon Medics of commitment and dedication of the consultants to ensure a successful
project completion.

## Key facts

- **NIH application ID:** 10574428
- **Project number:** 3R44AG061981-04S1
- **Recipient organization:** EVON MEDICS, LLC
- **Principal Investigator:** Charles Chiedu Nwaokobia
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $50,000
- **Award type:** 3
- **Project period:** 2018-09-30 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10574428

## Citation

> US National Institutes of Health, RePORTER application 10574428, Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD) (3R44AG061981-04S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10574428. Licensed CC0.

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