Alzheimer's Clinical Trials Consortium (ACTC)

阿尔茨海默病临床试验联盟 (ACTC)

• 批准号: 10719531
• 负责人: Paul S. Aisen
• 金额: $ 2812.54万
• 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 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10719531
• 关键词: Acceleration; Address; Agreement; Alzheimer' s Disease; Alzheimer' s disease pathology; Alzheimer' s disease related dementia; Alzheimer' s disease therapeutic; Alzheimer’s disease biomarker; American; Amyloid; Amyloid beta-Protein; Autopsy; Benchmarking; Biological Markers; Biometry; Blood; Brain; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Unit; Cognitive; Collaborations; Communities; Computer software; Consensus; Contracts; Country; Data; Data Analyses; Decision Making; Development; Disease; Education; Enrollment; Excision; Expenditure; Fostering; Funding; Future; Goals; Image; Immunoassay; Improve Access; Informatics; Information Systems; Infrastructure; Institutional Review Boards; Intervention; Justice; Leadership; Learning; Magnetic Resonance Imaging; Mass Spectrum Analysis; Measures; Medical; Mentors; Mentorship; Methods; Mission; Multicenter Trials; Neurodegenerative Disorders; Outcome; Outcome Measure; Participant; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Plasma; Population; Population Heterogeneity; Positron-Emission Tomography; Primary Prevention; Privatization; Procedures; Process; Protocols documentation; Registries; Research; Research Design; Research Personnel; Resources; Safety; Sampling; Screening procedure; Signal Transduction; Site; Slide; Specimen; Statistical Data Interpretation; Structure; Therapeutic; Therapeutic Trials; Tissue Banks; Training; Trust; U-Series Cooperative Agreements; Underrepresented Populations; United States National Institutes of Health; Work; asymptomatic Alzheimer' s disease; biobank; clinical trial participant; clinical trial recruitment; cognitive testing; computerized; data management; data sharing; design; digital; drug development; effective therapy; electronic data capture system; equity, diversity, and inclusion; evidence base; experience; follow-up; improved; innovation; instrument; neurodegenerative dementia; neuroimaging; neuropathology; next generation; novel; novel strategies; open data; operation; pragmatic trial; pre-clinical; programs; public-private partnership; recruit; screening; small molecule; success; tau Proteins; tau-1; trial design; trial enrollment; user-friendly

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.

总结。这是一个多PI应用程序，续订U24合作协议以维持和扩展 NIA最先进的阿尔茨海默病临床试验联盟(ACTC)负责进行学术临床 在阿尔茨海默病(AD)的整个过程中进行试验。本ACTC将继续利用深度和 南加州大学、哈佛大学和梅奥诊所的AD临床研究团队的广度，以及相当多的 调查人员在35个AD专家试验点的经验。我们的目标是保持优化的基础设施 高效地开发和实施高质量的NIH支持的AD和相关痴呆的临床试验，同时 通过将绝地原则融入绝地来满足对正义、公平、多样性和包容性的需求 所有联合体的基础设施、活动和研究。在我们最初五年的经验基础上，我们将利用 简化合同程序，建立一个集中的IRB，专门关注神经退行性疾病，以及 融合了最先进的信息学和统计分析。我们将有效管理以下项目的绩效 临床试验地点，同时确定、指导和支持新的试验地点，以改善获得临床试验的机会。 我们将促进AD试验设计的持续创新，提供新的认知、成像和 生物标记物结果，以支持未来的ACTC试验应用。我们将评估有前景的探索性 我们目前试验中嵌入的措施，如Tau PET成像和计算机化认知测试，以及 努力将这些措施整合到一个强大的平台中，以供未来的概念验证(POC)试验快速 评估疗效信号。反恐协调中心将利用经验丰富的团队 南加州大学临床运营、数据系统和管理以及生物统计学。由梅奥领导的核磁共振小组， 由哈佛大学和加州大学伯克利分校领导的PET部门将利用无与伦比的多站点经验 通过ADNI、A4研究和多项正在进行的临床试验的方案。临床结果测定仪 Biomarkers Units将利用来自梅奥、哈佛和南加州大学的世界级专业知识来整合这两家公司 未来试验设计中的标准和新的结果衡量标准。新的IDEA-CT单位将提供培训和 为年轻的临床研究人员提供领导机会，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提供最高水平的专业知识来设计和进行试验 在AD的整个过程中，从初级预防倡议到晚期AD的联合试验 有症状的阶段。我们将在公私伙伴关系的基础上再接再厉，继续 加强我们的战略联盟以进行大规模试验，同时支持新的方法 由调查人员发起的较小规模的POC研究，将更好地为阶段3决策提供信息。一项计划 促进临床试验参与者的纵向跟踪，为脑捐赠提供现场援助， 组织集中存储和共享是更新的另一个关键目标。

项目成果

Validity of Online Versus In-Clinic Self-Reported Everyday Cognition Scale.

• DOI: 10.14283/jpad.2022.20
• 发表时间: 2022
• 期刊: JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE
• 影响因子: 6.4
• 作者: Howell, T.;Neuhaus, J.;Glymour, M. M.;Weiner, M. W.;Nosheny, R. L.
• 通讯作者: Nosheny, R. L.

Comprehensive cross-sectional and longitudinal analyses of plasma neurofilament light across FTD spectrum disorders.

• DOI: 10.1016/j.xcrm.2022.100607
• 发表时间: 2022-04-19
• 期刊: CELL REPORTS MEDICINE
• 影响因子: 14.3
• 作者: Gendron, Tania F.;Heckman, Michael G.;White, Launia J.;Veire, Austin M.;Pedraza, Otto;Burch, Alexander R.;Bozoki, Andrea C.;Dickerson, Bradford C.;Domoto-Reilly, Kimiko;Foroud, Tatiana;Forsberg, Leah K.;Galasko, Douglas R.;Ghoshal, Nupur;Graff-Radford, Neill R.;Grossman, Murray;Heuer, Hilary W.;Huey, Edward D.;Hsiung, Ging-Yuek R.;Irwin, David J.;Kaufer, Daniel, I;Leger, Gabriel C.;Litvan, Irene;Masdeu, Joseph C.;Mendez, Mario F.;Onyike, Chiadi U.;Pascual, Belen;Ritter, Aaron;Roberson, Erik D.;Rojas, Julio C.;Tartaglia, Maria Carmela;Wszolek, Zbigniew K.;Rosen, Howard;Boeve, Bradley F.;Boxer, Adam L.;Petrucelli, Leonard
• 通讯作者: Petrucelli, Leonard

Brain amyloid burden, sleep, and 24-hour rest/activity rhythms: screening findings from the Anti-Amyloid Treatment in Asymptomatic Alzheimer's and Longitudinal Evaluation of Amyloid Risk and Neurodegeneration Studies.

• DOI: 10.1093/sleepadvances/zpab015
• 发表时间: 2021
• 期刊: Sleep advances : a journal of the Sleep Research Society
• 作者: Spira AP;Zipunnikov V;Raman R;Choi J;Di J;Bai J;Carlsson CM;Mintzer JE;Marshall GA;Porsteinsson AP;Yaari R;Wanigatunga SK;Kim J;Wu MN;Aisen PS;Sperling RA;Rosenberg PB
• 通讯作者: Rosenberg PB

Presence of Preoperative Neurodegeneration Biofluid Markers in Patients with Postoperative Delirium.

术后谵妄患者术前神经变性生物流体标志物的存在。

• DOI: 10.1097/aln.0000000000004666
• 发表时间: 2023
• 期刊: Anesthesiology
• 影响因子: 8.8
• 作者: Leung,JacquelineM;Rojas,JulioC;Tang,Christopher;Chan,Brandon;Lario-Lago,Argentina;Boxer,AdamL;Do,Quyen;Kramer,JoelH;Du,Zhiyuan;Du,Pang;Sands,LauraP;PerioperativeMedicineResearchGroup
• 通讯作者: PerioperativeMedicineResearchGroup

Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease.

Lecanemab 和 Elenbecestat 治疗早期阿尔茨海默病的 2 期和 3 期安慰剂对照、双盲、随机试验中不同种族和民族的美国参与者的合格率。

• DOI: 10.1002/ana.26819
• 发表时间: 2024
• 期刊: Annals of neurology
• 影响因子: 11.2
• 作者: Grill,JoshuaD;Flournoy,Charlene;Dhadda,Shobha;Ernstrom,Karin;Sperling,Reisa;Molina-Henry,Doris;Tranotti,Kate;Harris,Russell;Kanekiyo,Michio;Gee,Michelle;Irizarry,Michael;Kramer,Lynn;Aisen,Paul;Raman,Rema
• 通讯作者: Raman,Rema