Alzheimer's Clinical Trials Consortium (ACTC)

阿尔茨海默病临床试验联盟 (ACTC)

• 批准号: 10078230
• 负责人: Paul S. Aisen
• 金额: $ 1680.24万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-02 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10078230
• 关键词: Agreement; Alzheimer' s Disease; Alzheimer' s disease related dementia; American; Amyloid; Autopsy; Bioinformatics; Biological Assay; Biological Markers; Biometry; Blood; Blood Vessels; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Cognitive; Collaborations; Color; Combined Modality Therapy; Communities; Computer software; Consensus; Contracts; Country; Data; Data Analyses; Decision Making; Dementia; Development; Disease; Early intervention trials; Enrollment; Fostering; Funding; Future; Image; Informatics; Information Systems; Infrastructure; Institution; Institutional Review Boards; Intervention; Leadership; Learning; Magnetic Resonance Imaging; Measures; Medical; Methods; Minority; Modeling; Monitor; Network Infrastructure; Neurodegenerative Disorders; Outcome; Outcome Measure; Outcome Study; Participant; Pathology; Patient Recruitments; Phase; Play; Population Heterogeneity; Positron-Emission Tomography; Prevention trial; Primary Prevention; Probability; Procedures; Process; Protocols documentation; Research Design; Research Personnel; Resources; Risk; Role; Sampling; Secondary Prevention; Secure; Signal Transduction; Site; Specimen; Statistical Data Interpretation; Structure; TimeLine; Tissues; Training; U-Series Cooperative Agreements; United States National Institutes of Health; Work; age related; base; biobank; cognitive testing; cohort; computerized; cooperative study; data management; data sharing; design; drug development; effective therapy; electronic data capture system; experience; imaging biomarker; improved; innovation; instrument; meetings; mild cognitive impairment; neurodegenerative dementia; neuroimaging; neuropathology; next generation; novel; novel strategies; operation; outreach; participant retention; polygenic risk score; pre-clinical; prediction algorithm; programs; public-private partnership; recruit; retention rate; success; tau Proteins; trial design

SUMMARY. This is a multi-PI application for the U24 Cooperative Agreement to develop a state-of-the-art Alzheimer Clinical Trial Consortium (ACTC) to support the conduct of academic clinical trials across the continuum of Alzheimer's disease (AD). This ACTC will leverage the depth and breadth of AD clinical research teams at USC, Harvard, and the Mayo Clinic, as well as the considerable experience of investigators at 35 expert AD trial sites. We aim to create an optimized infrastructure to more efficiently launch, rapidly recruit, improve the diversity, and successfully complete NIH supported clinical trials in AD and related dementias. We will utilize streamlined contracting processes, a centralized IRB with a specific focus on neurodegenerative diseases, and incorporate state-of-the-art informatics and statistical analyses. We propose to redouble our efforts to improve the diversity of participants in AD clinical trials, incorporating learnings from our recent experience, and establishing a new Minority Outreach and Recruitment (MORE) Team to support both central and local partnerships with communities of color. We will foster continued innovation in AD trial design, providing expertise on novel cognitive, imaging, and biomarker outcomes to support future ACTC trial applications. We will evaluate promising exploratory measures imbedded in our current trials, such as Tau PET imaging and computerized cognitive testing, and work to incorporate these measures into a robust platform for future Proof of Concept (POC) trials to rapidly assess signals of efficacy. We propose a tightly coordinated, distributed leadership model to create a true consortium and take full advantage of the expertise across multiple institutions. The ACTC Coordinating Center will leverage the highly experienced teams in Clinical Operations, Data Systems and Management, and Biostatistics at USC. The MRI Unit, led by Mayo, and PET Unit, led by Harvard and UC Berkeley, will capitalize on unparalleled experience with multi-site protocols through ADNI, the A4 Study, and multiple ongoing clinical trials. The Clinical Outcome Instrument and Biomarkers Units will leverage world-class expertise from Mayo, Harvard, and USC to incorporate both standard and novel outcome measures in future trial designs. This ACTC will provide expertise and infrastructure to design and conduct trials across the full continuum of AD, from primary prevention initiatives to combination trials for advanced symptomatic stages. We also stand ready to collaborate on trials in other age- related dementias, leveraging the experience of the NeuroNext team at Harvard and other expert investigators in vascular and non-AD neurodegenerative diseases. We will build on our successes with public/private partnerships and continue to strengthen our strategic alliances to conduct large scale trials, but will also focus on supporting novel approaches to smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. Finally, we will provide training and leadership opportunities to young clinical investigators to facilitate continued innovation in trial design, and catalyze the next generation of AD clinical trials.

概括。这是U24合作协议的多PIP申请，以开发最先进的 阿尔茨海默氏症临床试验联盟（ACTC）支持整个临床试验的进行 阿尔茨海默氏病（AD）的连续体。该ACTC将利用AD临床研究的深度和广度 南加州大学，哈佛大学和梅奥诊所的团队，以及35岁的调查人员的丰富经验 专家广告试用网站。我们旨在创建一个优化的基础架构，以更有效地启动，快速招募， 改善多样性，并成功完成NIH支持AD和相关痴呆症的临床试验。我们 将利用精简的合同过程，这是一种集中的IRB，特别关注神经退行性 疾病，并纳入最先进的信息学和统计分析。我们建议加倍 为改善广告临床试验中参与者多样性的努力，并从我们最近的学习中纳入了学习 经验，并建立新的少数族裔宣传和招聘（更多）团队来支持这两个中央 以及与有色社区的当地伙伴关系。我们将促进广告试验设计中的持续创新， 提供有关新颖认知，成像和生物标志物结果的专业知识，以支持未来的ACTC试验 申请。我们将评估当前试验中嵌入的有希望的探索措施，例如TAU 宠物成像和计算机认知测试，并致力于将这些措施纳入强大的 未来概念证明（POC）试验的平台，以快速评估功效信号。我们紧紧提出 协调的，分布式领导模型，以创建一个真正的财团并充分利用专业知识 跨多个机构。 ACTC协调中心将利用经验丰富的团队 USC的临床操作，数据系统和管理以及生物统计学。由梅奥（Mayo）领导的MRI单元， 由哈佛和加州大学伯克利分校领导的宠物单位将利用多站点的无与伦比的体验 通过ADNI，A4研究和多次正在进行的临床试验的方案。临床结果工具 生物标志物单元将利用梅奥，哈佛和南加州大学的世界一流的专业知识来纳入这两者 未来试验设计中的标准和新颖的结果度量。该ACTC将提供专业知识，并 从主要的预防计划到全面设计和进行试验的基础设施，从主要预防计划到 晚期症状阶段的组合试验。我们还准备在其他年龄的试验中进行合作 - 相关的痴呆症，利用哈佛大学的神经网站团队和其他专家调查员的经验 在血管和非AD神经退行性疾病中。我们将以公共/私人的成功为基础 伙伴关系并继续加强我们的战略联盟以进行大规模试验，但也将集中精力 在支持较小研究者发起的POC研究的新型方法上，该研究将更好地告知第3阶段 决策。最后，我们将向年轻的临床研究人员提供培训和领导机会 促进试验设计中的持续创新，并促进下一代AD临床试验。