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

摘要

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.