Alzheimer's Clinical Trial InnOvatioN (ACTION) Initiative

阿尔茨海默病临床试验 InnOvatioN (ACTION) 计划

• 批准号: 10388232
• 负责人: JEFFREY L. CUMMINGS
• 金额: $ 59.16万
• 依托单位: UNIVERSITY OF NEVADA LAS VEGAS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10388232
• 关键词: Address; Advisory Committees; Alzheimer' s Disease; Alzheimer' s disease related dementia; Area; Artificial Intelligence; Award; Bioinformatics; Biological Markers; Characteristics; Clinical; Clinical Research; Clinical Trials; Complex; Computers; Congresses; Data; Databases; Development; Disease; Engineering; Ensure; Future; Goals; Growth; Industry; Information Dissemination; Institutes; Laws; Leadership; Machine Learning; Mentors; Mentorship; National Institute on Aging; Neuropsychology; Outcome; Patients; Pharmacology; Phase; Principal Investigator; Psychiatry; Publishing; Registries; Research; Research Personnel; Risk; Scientist; Site; Techniques; Translational Research; base; clinical biomarkers; data registry; deep learning; drug development; drug mechanism; innovation; multidisciplinary; novel therapeutics; preclinical trial; predictive modeling; prodromal Alzheimer' s disease; programs; statistics; trial design; web portal; web-accessible; Address; Advisory Committees; Alzheimer' s Disease; Alzheimer' s disease related dementia; Area; Artificial Intelligence; Award; Bioinformatics; Biological Markers; Characteristics; Clinical; Clinical Research; Clinical Trials; Complex; Computers; Congresses; Data; Databases; Development; Disease; Engineering; Ensure; Future; Goals; Growth; Industry; Information Dissemination; Institutes; Laws; Leadership; Machine Learning; Mentors; Mentorship; National Institute on Aging; Neuropsychology; Outcome; Patients; Pharmacology; Phase; Principal Investigator; Psychiatry; Publishing; Registries; Research; Research Personnel; Risk; Scientist; Site; Techniques; Translational Research; base; clinical biomarkers; data registry; deep learning; drug development; drug mechanism; innovation; multidisciplinary; novel therapeutics; preclinical trial; predictive modeling; prodromal Alzheimer' s disease; programs; statistics; trial design; web portal; web-accessible

Abstract The National Institute on Aging Alzheimer's Disease and Related Dementias Research Implementation Milestones articulate the goals of the Institute for advancing Alzheimer's disease (AD) research. The Leadership Award for AD and Related Disorders requires that the applicant address objectives of the Milestones and provide mentorship to new and early stage investigators. The research proposed must be groundbreaking and paradigm changing. Among the eight focus areas within the Implementation Milestones' framework are Trial Innovation and Translation and Clinical Research – Pharmacological. The Alzheimer's Clinical Trial InnOvationN (ACTION) Initiative proposed here embraces both the research and mentoring aspects of the Leadership Award. The ACTION Initiative will include development of a Clinical Trials Observatory (CTO) and an embedded mentorship program. The CTO builds on the principal investigator's prior analyses of clinicaltrials.gov. This federal registry contains all trials conducted in the US and many trials conducted ex-US. It includes Phase 1, 2 and 3 clinical trials of preclinical, prodromal, and AD dementia trials. The PI has conducted and published research on the trial design, biomarker, and clinical outcomes data from the registry. In 2016, Congress passed a law requiring that trial outcomes be posted on the site within 1 year of completion of the trial. The PI proposes to build a multi-disciplinary team of engineers, computer scientists, statisticians, and bioinformatic experts to interrogate the range of data now available using artificial intelligence techniques including machine learning and deep learning. An external advisory committee will ensure quality and dissemination. The Alzheimer's Association will collaborate on results dissemination. An accessible web portal for the database will make reviewed data readily available for analyses and prediction/modeling of planned clinical trials. The growing database of real-world AD trial data will allow increasingly precise prediction of trial outcomes based on complex relationships among baseline features, trajectories of decline, drug mechanisms, and clinical and biomarker characteristics across all stages of AD. The data will be used by the PI, mentees, academic trial leaders, and industry trial sponsors. Three initial mentees are identified from neuropsychology, psychiatry, and engineering; more will be added with growth of the program. The ACTION Initiative has the potential to transform clinical trial planning and outcomes, leading to substantial impact on the Implementation Milestones of the NIA and accelerating development of new therapies for patients with AD and those at risk. Mentees will power the future of AD drug development and clinical trial planning.

抽象的 美国国家老龄化阿尔茨海默氏病和相关痴呆症研究实施的研究所 里程碑阐明了前进阿尔茨海默氏病（AD）研究的目标。这 广告和相关疾病的领导奖要求 里程碑，并为新的和早期的调查人员提供心态。提出的研究必须 开创性和范式改变。在实施中的八个重点领域中 里程碑的框架是试验创新，翻译和临床研究 - 药理学。 阿尔茨海默氏症的临床试验Innovationn（行动）倡议在这里提出 领导奖的研究和心理方面。行动计划将包括 开发临床试验天文台（CTO）和嵌入式Mentalship计划。首席执行官 建立在首席研究者先前对ClinicalTrials.gov的分析的基础上。该联邦注册表包含全部 在美国进行的试验和许多试验进行了前US。它包括1、2和3阶段的临床试验 临床前，前驱和AD痴呆症试验。 PI已经进行并发表了有关 试验设计，生物标志物和临床结果来自注册表。 2016年，国会通过了一项法律 要求在审判完成后的1年内将试验结果发布在现场。 PI建议 建立一个由工程师，计算机科学家，统计学家和生物信息学专家组成的多学科团队 询问现在使用人工智能技术在内的现在可用的数据范围 学习和深度学习。外部咨询委员会将确保质量和传播。这 阿尔茨海默氏症协会将在结果传播方面合作。一个可访问的Web门户网站 数据库将使审核的数据随时可用，用于分析和预测/建模 临床试验。现实世界广告试验数据的增长数据库将允许越来越精确的预测 基于基线特征之间复杂关系，下降轨迹，药物的复杂关系的试验结果 AD的所有阶段的机制，临床和生物标志物特征。数据将使用 由PI，Mendes，学术审判负责人和行业审判发起人。确定了三个初始门德 来自神经心理学，精神病学和工程学；该计划的增长将增加更多。这 行动计划有可能改变临床试验计划和结果，从而实现 对NIA实施里程碑的影响，并加速了新疗法的发展 AD患者和有危险的患者。受训者将为AD药物开发和临床的未来提供动力 试用计划。