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

摘要 Evon Medics，LLC建议评估和优化便携式家庭产品-计算机化 嗅觉训练计划(COT)--预防进行性认知障碍的疾病修正干预措施 前驱症状和早期阿尔茨海默病(AD)中的衰退和进行性痴呆。婴儿床使用经过验证的 神经保护性嗅觉刺激剂强烈刺激初级和次级嗅觉皮质， 克服嗅觉习惯性的刺激参数，与计算机化的嗅觉认知相结合 协同增强相同大脑区域的训练任务；目标是增加结构性和 对AD进展的功能性恢复能力。这一创新的解决方案，尽管它有希望改变疾病 治疗特性和有希望的临床试验结果，将不会被FDA批准并提供给 数十亿名患者患有这种令人衰弱的神经系统疾病，这项创新有望治疗这种疾病， 没有一个具体的、全面的、万无一失的监管战略、实施和执行。埃文 医务人员，根据其Taba需求评估协商的建议，以及 许多行业知名人士和咨询公司的建议已决定重新审视其监管 战略并聘请声誉良好且高度推荐的监管咨询公司，以确保成功 FDA批准并投放市场。 为推动FDA成功通过审批而聘请的监管咨询公司拥有广泛的 通过成功的监管流程使药品、生物制品和设备获得FDA的批准和 将参与重新定义针对COT和其他相关Evon的Evon Medics监管策略 医疗产品是其专利嗅觉治疗输送系统(OTDS)的衍生产品。这个 服务还包括准备和ECTD重新提交IND，并与FDA联系以确保 审批，在整个研究期间提供持续的监管咨询服务，IND年度报告 准备和提交，并执行监管战略，以确保FDA成功通过。 经验丰富的监管顾问已被指派领导和执行该项目和 公司已向Evon医疗人员保证，顾问的承诺和奉献精神将确保成功 项目竣工。

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.