Alzheimer's Clinical Trial InnOvatioN (ACTION) Initiative

阿尔茨海默病临床试验 InnOvatioN (ACTION) 计划

• 批准号: 10180707
• 负责人: JEFFREY L. CUMMINGS
• 金额: $ 59.76万
• 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/10180707
• 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.

抽象的 国家老年痴呆症及相关痴呆症研究所实施研究 里程碑阐明了研究所推进阿尔茨海默病 (AD) 研究的目标。 AD 及相关疾病领导奖要求申请人解决该奖项的目标 所提议的研究必须具有里程碑意义并为新的和早期的研究人员提供指导。 是实施中的八个重点领域之一。 里程碑的框架是试验创新和转化以及临床研究 - 药理学。 这里提出的阿尔茨海默病临床试验 InnOvationN (ACTION) 计划包括 领导力奖的研究和指导方面将包括。 开发临床试验观察站 (CTO) 和嵌入式指导计划。 建立在主要研究者之前对 ClinicalTrials.gov 的分析的基础上。该联邦登记处包含所有内容。 在美国进行的试验以及在美国境外进行的许多试验，包括 1 期、2 期和 3 期临床试验。 PI 已开展并发表了有关临床前、前驱和 AD 痴呆试验的研究。 2016 年，国会通过了一项法律。 PI 建议在试验完成后 1 年内将试验结果发布在网站上。 建立一支由工程师、计算机科学家、统计学家和生物信息专家组成的多学科团队 使用人工智能技术（包括机器）询问现有的数据范围 外部咨询委员会将确保质量和传播。 阿尔茨海默病协会将合作发布结果。 数据库将使审查的数据随时可用于分析和预测/建模计划 不断增长的真实世界 AD 试验数据数据库将使预测变得越来越精确。 基于基线特征、衰退轨迹、药物之间复杂关系的试验结果 AD 各阶段的机制、临床和生物标志物特征将被使用。 由 PI、受训者、学术试验领导者和行业试验发起人确定了三名初始受训者。 来自神经心理学、精神病学和工程学的知识；随着项目的发展，还会增加更多内容。 ACTION Initiative 有潜力改变临床试验计划和结果，从而带来实质性的成果 对 NIA 实施里程碑的影响并加速新疗法的开发 AD 患者和高危人群将为 AD 药物开发和临床的未来提供动力。 试验规划。