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

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.

摘要 国家老龄阿尔茨海默病及相关痴呆症研究所研究实施 里程碑阐明了该研究所推进阿尔茨海默病(AD)研究的目标。这个 AD及相关障碍领导力奖要求申请者说明 并为新的和早期的调查人员提供指导。建议的研究必须 具有开创性，并改变模式。在执行工作的八个重点领域中 里程碑的框架是试验创新和翻译以及临床研究-药理学。 这里提出的阿尔茨海默病临床试验InnOvationN(ACTION)倡议既包括 领导力奖的研究和指导方面。该行动计划将包括 开发临床试验观察站(CTO)和嵌入式指导计划。首席技术官 建立在首席研究员对临床试验的先前分析的基础上。此联邦注册表包含所有 在美国进行的试验和许多试验是在美国以外进行的。它包括1期、2期和3期临床试验 临床前、前驱症状和阿尔茨海默病试验。国际刑警组织进行并发表了关于 来自注册中心的试验设计、生物标记物和临床结果数据。2016年，国会通过了一项法律 要求在试验完成后1年内将试验结果公布在网站上。私生党提议 建立一支由工程师、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 使用人工智能技术(包括机器)查询目前可用的数据范围 学习和深度学习。外部咨询委员会将确保质量和传播。这个 阿尔茨海默氏症协会将在结果传播方面进行合作。可访问的门户网站，用于 数据库将使审查的数据随时可用于分析和预测/建模规划 临床试验。不断增长的真实AD试验数据数据库将使预测变得越来越准确 基于基线特征、下降轨迹、药物之间的复杂关系的试验结果 机制，以及AD所有阶段的临床和生物标记物特征。将使用这些数据 由PI、指导者、学术试验负责人和行业试验赞助商提供。确定了三个初始指导对象 来自神经心理学、精神病学和工程学；随着该项目的发展，将增加更多。这个 行动倡议有可能改变临床试验计划和结果，导致 对NIA实施里程碑的影响和加速开发新的治疗方法 阿尔茨海默病患者和高危患者。导师将推动AD药物开发和临床的未来 试验计划。