Alzheimers Clinical Trials Consortium (ACTC)

阿尔茨海默病临床试验联盟 (ACTC)

• 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
• 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' 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; 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.

摘要这是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），以支持跨学科的学术临床试验的开展。 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，哈佛和马约诊所的团队，以及35岁的调查人员的丰富经验， 专家AD试验网站。我们的目标是创建一个优化的基础设施，以更有效地启动，快速招聘， 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，集中的IRB，特别关注神经退行性疾病 疾病，并纳入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，结合我们最近的研究结果， 经验，并建立一个新的少数民族外联和招聘（更多）团队，以支持中央和 和当地有色人种社区的合作。我们将促进AD试验设计的持续创新， 提供关于新型认知、成像和生物标志物结局的专业知识，以支持未来的ACTC试验 应用.我们将评估嵌入我们当前试验中的有希望的探索性措施，如Tau PET成像和计算机化认知测试，并努力将这些措施纳入一个强大的 未来概念验证（POC）试验的平台，以快速评估疗效信号。我们提出了一个紧密的 协调的分布式领导模式，以创建真正的联盟，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， 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研究和多项正在进行的临床试验制定方案。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。该ACTC将提供专业知识， 基础设施，以设计和实施从初级预防措施到 晚期症状的联合试验。我们也随时准备在其他时代的审判中进行合作- 利用哈佛的NeuroNext团队和其他专家调查人员的经验， 血管和非AD神经退行性疾病。我们将在成功的基础上与公共/私营部门合作， 合作伙伴关系，并继续加强我们的战略联盟，进行大规模的试验，但也将重点 支持新方法，以更好地为III期研究提供信息， 决策的最后，我们将为年轻的临床研究者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。