Alzheimers Clinical Trials Consortium (ACTC)

阿尔茨海默病临床试验联盟 (ACTC)

基本信息

批准号：
9753042
负责人：
Paul S. Aisen
金额：
$ 225.2万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-12-02 至 2022-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9753042
关键词：
Agreement Alzheimer&apos s Disease Alzheimer&apos 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 pre-clinical prediction algorithm programs public-private partnership recruit retention rate success tau Proteins trial design

项目摘要

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 PI 应用程序，旨在开发最先进的阿尔茨海默病临床试验联盟 (ACTC) 支持在整个国家/地区开展学术临床试验阿尔茨海默病（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 岁的研究人员的丰富经验专家 AD 试用网站。我们的目标是创建一个优化的基础设施，以更有效地启动、快速招募、提高多样性，并成功完成 NIH 支持的 AD 和相关痴呆症临床试验。我们将利用简化的合同流程，一个专门关注神经退行性疾病的集中式 IRB 疾病，并结合最先进的信息学和统计分析。我们建议加倍努力努力提高 AD 临床试验参与者的多样性，结合我们最近的经验教训经验，并建立一个新的少数族裔外展和招聘（更多）团队来支持中央以及与有色人种社区的当地合作伙伴关系。我们将促进 AD 试验设计的持续创新，提供有关新型认知、成像和生物标志物结果的专业知识，以支持未来的 ACTC 试验应用程序。我们将评估当前试验中嵌入的有前途的探索性措施，例如 Tau PET 成像和计算机化认知测试，并努力将这些措施纳入强有力的未来概念验证 (POC) 试验的平台，以快速评估功效信号。我们建议严格协调、分布式领导模式，创建真正的联盟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南加州大学的临床操作、数据系统和管理以及生物统计学。由 Mayo 领导的 MRI 部门由哈佛大学和加州大学伯克利分校领导的 PET 部门将利用多站点无与伦比的经验通过 ADNI、A4 研究和多项正在进行的临床试验的协议。临床结果仪器和生物标志物部门将利用梅奥、哈佛大学和南加州大学的世界一流专业知识将两者结合起来未来试验设计中的标准和新颖的结果测量。该 ACTC 将提供专业知识和设计和进行整个 AD 连续性试验的基础设施，从初级预防举措到晚期症状阶段的联合试验。我们还准备在其他年龄的试验上进行合作相关痴呆症，利用哈佛大学 NeuroNext 团队和其他专家研究人员的经验血管和非 AD 神经退行性疾病。我们将在公共/私人领域的成功基础上再接再厉伙伴关系并继续加强我们的战略联盟以进行大规模试验，但也将重点关注支持小型研究者发起的 POC 研究的新方法，这将更好地为第 3 阶段提供信息决策。最后，我们将为年轻的临床研究人员提供培训和领导机会促进试验设计的持续创新，并促进下一代 AD 临床试验。