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

针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估

• 批准号: 10574428
• 负责人: Charles Chiedu Nwaokobia
• 金额: $ 5万
• 依托单位: EVON MEDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10574428
• 关键词: Alzheimer' s Disease; Biological Products; Brain region; Clinical Trials; Consult; Consultations; Dedications; Dementia; Development; Devices; Disease; Disease Progression; Ensure; Evaluation; Goals; Home; Impaired cognition; Industry; Lead; Legal patent; Mission; Needs Assessment; Olfactory Cortex; Patients; Pharmaceutical Preparations; Preparation; Process; Property; Recommendation; Reporting; Services; Stimulant; System; Therapeutic; Training Programs; base; cognitive training; computerized; experience; habituation; innovation; nervous system disorder; portability; preventive intervention; resilience

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.

抽象的 Evon Medics，LLC提案，以评估和优化便携式家庭产品 - 计算机化 嗅觉培训计划（COT） - 作为一种预防进行性认知的疾病的疾病 前驱和早期阿尔茨海默氏病（AD）的下降和进行性痴呆。婴儿床使用经过验证的 神经保护性嗅觉刺激剂，以诚实地与主要和次要嗅皮层接合，并与 克服嗅觉习惯的刺激参数，并与计算机化的认知能力配对 训练协同增强相同大脑区域的培训任务；以增加结构性和 对广告进展的功能弹性。这种创新的解决方案，使命其承诺疾病修改 治疗特性和有前途的临床试验结果，不会清除FDA，并且可用于 数十亿名因衰弱的神经系统疾病而受苦的患者，创新有望治疗， 没有具体，全面和万无一失的监管策略，实施和执行。埃文 根据其TABA需求评估咨询的建议，医务人员以及 许多行业杰出人物和顾问的建议决定重新审视其监管 策略并雇用声誉和强烈推荐的监管咨询公司，以确保成功 FDA许可和市场发布。 雇用的监管咨询公司为成功的FDA许可而雇用了任务差距 通过成功的监管过程来吸收药物，生物制剂和设备的经验 将参与重新定义COT和其他相对Evon的EVON MEDIC调节策略 是其专利嗅觉治疗输送系统（OTD）的衍生品的医疗产品。这 服务还将包括对IND的准备工作和ECTD重新提交与FDA的联络人，以确保 在整个研究期间，清除，连续的监管咨询服务，年度IND报告 准备和提交，以及执行监管策略，以确保成功获得FDA清除。 经验丰富的监管顾问已被指派领导和执行该项目， 公司已采用Evon的承诺和奉献精神，以确保成功 项目完成。