NAPS2 Administrative Core

NAPS2 管理核心

• 批准号: 10187083
• 负责人: Yo-El S Ju
• 金额: $ 453.81万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10187083
• 关键词: Address; Administrative Supplement; American; Applications Grants; Biological Markers; Biological Specimen Banks; Cessation of life; Clinical Trials; Collection; Communication; Communities; Conflict of Interest; Data; Decision Making; Dementia with Lewy Bodies; Development; Enrollment; Ensure; Foundations; Goals; Human Resources; Institutional Review Boards; Lead; Leadership; Licensing; Mentorship; Mind; Multiple System Atrophy; North America; Parkinson Disease; Participant; Persons; Phenotype; Procedures; Process; Protocols documentation; Publications; REM Sleep Behavior Disorder; Records; Regulation; Reporting; Research; Research Personnel; Research Project Grants; Resources; Scientist; Site; Site Visit; Specimen; Standardization; Structure; Time; United States National Institutes of Health; cohort; cooperative study; data quality; data repository; disability; follow-up; industry partner; investigator training; loss of function; meetings; participant enrollment; prevent; progressive neurodegeneration; scientific organization; synucleinopathy; tool; treatment trial

ABSTRACT: NAPS2 ADMINISTRATIVE CORE Synucleinopathies including Parkinson disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA) in aggregate afflict ~2 million Americans, and lead to progressive neurodegeneration and loss of function toward severe disability and death. Rapid eye movement (REM) Sleep Behavior Disorder (RBD) usually reflects a prodromal synucleinopathy, and presents a window of opportunity when treatment may be effective to prevent or slow the progression to overt synucleinopathy. The North American Prodromal Synucleinopathy (NAPS) Consortium for RBD was established in 2018 to prepare for such neuroprotective treatment trials. As NAPS1—the current, R34-supported stage of NAPS—we have been very successful in engaging key RBD researchers and cohorts across North America. NAPS1 has been extremely productive: >200 participants have thus far been enrolled across 10 Sites, and have completed standardized, comprehensive assessments. We established key administrative procedures and processes in parallel with rapid enrollment, and NAPS1 functions smoothly as a transparent, efficient Consortium. To address important questions about biomarkers and phenotypic trajectories in prodromal synucleinopathy, we propose Stage 2 of NAPS, or NAPS2, to enable longitudinal followup and expanded biomarker collection. NAPS2 will build and substantially expand upon NAPS1, to establish 8 Cores that support a central research Project. The Administrative Core will formalize and streamline the administrative tasks across NAPS2 and all its components. The current Sites will come under the umbrella of the Administrative Core as they continue into NAPS2, and the Administrative Core will oversee the activities and interactions between all NAPS2 components. The Aims of the Administrative Core are to 1) coordinate all NAPS2 Cores, Sites, Project, personnel, and resources; 2) facilitate communication within and outside of NAPS; 3) safeguard data quality and consistency across the NAPS Consortium; 4) promote research in RBD; and 5) guarantee compliance with required regulatory bodies. The NAPS2 Administrative Core will oversee the inter-relationships between NAPS2 components with the goal of an efficient and productive Consortium. Through the proposed aims, the Administrative Core will enable all NAPS2 components to perform optimally, toward the goal of neuroprotective clinical trials to slow or stop the progression of synucleinopathies.

摘要：NAPS2 管理核心 突触核蛋白病，包括帕金森病 (PD)、路易体痴呆 (DLB) 和多种 系统萎缩（MSA）总共困扰着约 200 万美国人，并导致进行性神经退行性变 以及功能丧失导致严重残疾和死亡。快速眼动 (REM) 睡眠行为障碍 (RBD) 通常反映前驱期突触核蛋白病，并且在治疗时提供了机会之窗 可能有效预防或减缓明显的突触核蛋白病的进展。北美前驱期 RBD 突触核蛋白病 (NAPS) 联盟成立于 2018 年，旨在为此类神经保护药物做准备 治疗试验。作为 NAPS1（NAPS 当前支持 R34 的阶段），我们在以下方面取得了非常成功的成果： 吸引北美主要 RBD 研究人员和群体的参与。 NAPS1 非常富有成效： 迄今为止，已在 10 个站点注册了超过 200 名参与者，并已完成标准化、 综合评估。我们同时制定了关键的行政程序和流程 快速注册，并且 NAPS1 作为一个透明、高效的联盟顺利运作。解决重要的 关于前驱突触核蛋白病的生物标志物和表型轨迹的问题，我们建议第二阶段 NAPS 或 NAPS2，用于实现纵向随访和扩大生物标志物收集。 NAPS2 将构建并 大幅扩展 NAPS1，建立 8 个核心来支持中央研究项目。这 管理核心将正式化并简化 NAPS2 及其所有项目的管理任务 成分。当前站点将在行政核心的保护下继续发展 NAPS2 和行政核心将监督所有 NAPS2 之间的活动和互动 成分。管理核心的目标是 1) 协调所有 NAPS2 核心、站点、项目、 人员和资源； 2) 促进 NAPS 内部和外部的沟通； 3）保障数据质量 以及整个 NAPS 联盟的一致性； 4）促进RBD研究； 5) 保证遵守 所需的监管机构。 NAPS2 管理核心将监督各机构之间的相互关系 NAPS2 组件的目标是建立一个高效且富有成效的联盟。通过拟议的目标， 管理核心将使所有 NAPS2 组件能够以最佳方式运行，以实现以下目标： 减缓或阻止突触核蛋白病进展的神经保护临床试验。