Alzheimer's Clinical Trials Consortium (ACTC)

摘要这是一个多PI应用程序，更新U24合作协议，以维持和扩大 NIA最先进的阿尔茨海默氏症临床试验联盟（ACTC）负责进行学术临床研究， 阿尔茨海默病（AD）的连续性试验。该ACTC将继续利用深度和 南加州大学、哈佛和马约诊所的AD临床研究团队的广度，以及相当大的 35个专家AD试验中心的研究者经验。我们的目标是维持优化的基础设施， 有效地开发和进行高质量的NIH支持的AD和相关痴呆症临床试验， 通过将JEDI原则纳入各地区，满足正义、公平、多样性和包容性（JEDI）的需求。 所有联合体基础设施、活动和研究。基于我们前五年的经验，我们将利用 简化的合同流程，集中的IRB，特别关注神经退行性疾病， 结合最新信息学和统计分析。我们将有效管理 临床试验地点，同时确定、指导和支持新的试验地点，以改善临床试验的可及性。 我们将促进AD试验设计的持续创新，提供新的认知、成像和 生物标志物结果，以支持未来的ACTC试验应用。我们将评估有前景的探索性研究， 在我们目前的试验中嵌入的措施，如Tau PET成像和计算机化认知测试， 努力将这些措施纳入未来概念验证（POC）试验的强大平台， 评估疗效信号。ACTC协调中心将利用经验丰富的团队， 临床操作，数据系统和管理，以及南加州大学的生物统计学。由马约领导的核磁共振成像组， 由哈佛大学和加州大学伯克利分校领导的PET部门将利用其在多站点方面无与伦比的经验， 通过ADNI，A4研究和多个正在进行的临床试验的协议。临床结果工具 生物标志物部门将利用来自马约、哈佛和南加州大学的世界级专业知识， 在未来的试验设计中采用标准和新的结局指标。新的IDEA-CT股将提供培训， 年轻临床研究者的领导机会，以促进试验设计的持续创新，以及 催化下一代AD临床试验。 组成这一基础设施的专家为设计和开展试验提供最高水平的专业知识 在AD的整个连续性中，从初级预防措施到晚期 症状分期我们将在公私伙伴关系成功的基础上再接再厉， 加强我们的战略联盟，进行大规模试验，同时也支持新的方法， 更小规模的制药商发起的POC研究，将更好地为III期决策提供信息。程序 促进临床试验参与者的纵向随访，并在研究中心协助下进行脑捐赠， 集中组织库和共享是更新的另一个关键目标。

SUMMARY. This is a multi-PI application renewing the U24 Cooperative Agreement to sustain and expand the NIA’s state-of-the-art Alzheimer Clinical Trial Consortium (ACTC) responsible for conducting academic clinical trials across the continuum of Alzheimer’s disease (AD). This ACTC will continue to 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 sustain the optimized infrastructure that efficiently develops and conducts high quality NIH supported clinical trials in AD and related dementias, while addressing the need for Justice, Equity, Diversity, and Inclusion (JEDI) by incorporating JEDI principles across all consortium infrastructure, activities, and studies. Building on our first five years of experience, 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 will effectively manage performance of clinical trial sites, while identifying, mentoring and supporting new trial sites to improve access to clinical trials. 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. 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. The new IDEA-CT Unit 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. The experts comprising this infrastructure provide the highest levels of expertise to design and conduct trials across the full continuum of AD, from primary prevention initiatives to combination trials for advanced symptomatic stages. We will build on our successes with public/private partnerships and continue to strengthen our strategic alliances to conduct large scale trials, while also supporting novel approaches to smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. A program facilitating the longitudinal follow up of clinical trial participants with site assistance for brain donation, centralizing tissue banking and sharing is another key aim of the renewal.