HABS-HD - Core C - Clinical Core

HABS-HD - 核心 C - 临床核心

• 批准号: 10708870
• 负责人: Sid E O'Bryant
• 金额: $ 1154.5万
• 依托单位: UNIVERSITY OF NORTH TEXAS HLTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708870
• 关键词: Adherence; Adult; African American population; Age; Agreement; Alzheimer' s Disease; Alzheimer' s disease related dementia; Ancillary Study; Back; Behavioral; Biological Markers; Blood specimen; Brain; Cataloging; Cerebrospinal Fluid; Clinical; Clinical Data; Cognitive; Collaborations; Collection; Communities; Community Relations; Consensus; Consent; Data; Data Collection; Diagnosis; Disparity; Educational Materials; Enrollment; Ensure; Ethnic Population; Family; Feedback; Focus Groups; Foundations; Goals; Health; Health Disparities Research; Health Personnel; Image; Informatics; Informed Consent; Infrastructure; Interview; Letters; Licensing; Magnetic Resonance Imaging; Measures; Medical; Mexican Americans; Modeling; Monitor; Multicultural Education; Neuropsychology; Not Hispanic or Latino; Parents; Participant; Persons; Population; Positron-Emission Tomography; Prevention strategy; Printing; Procedures; Process; Protocols documentation; Real-Time Systems; Research; Sampling; Spinal Puncture; Standardization; Time; Update; Visit; Work; aging brain; biobank; clinical diagnosis; cohort; electronic data capture system; future implementation; health disparity; health goals; informant; neuroimaging; novel; outreach; participant interview; precision medicine; programs; racial population; recruit; social culture; treatment strategy; virtual; web site

HABS-HD CLINICAL CORE (CORE C) ABSTRACT The long-term goal of the Health & Aging Brain Study – Health Disparities (HABS-HD) is to establish a population-specific informed precision medicine for novel treatment and prevention strategies for Alzheimer’s disease (AD) as called for in NIA AD+ADRD Milestone 1. The Clinical Core (Core C) will meet this goal by continuing to conduct all direct participant interviews, assessments, imaging, and other protocol components (parent study and/or ancillary studies). By the time of the initiation of the U19, the cohort will consist of 3,000 community-dwelling participants ages 50 and above (n=1,000 African Americans [AA], 1,000 Mexican Americans [MA], and 1,000 non-Hispanic whites [NHW]). Visit one (V1) and 24-month longitudinal V2 data will be available at initiation of the U19 among the MA and NHW participants with V1 data available for the AA participants. As part of this U19, we will continue 24-month assessments of the existing cohort as well as enroll an additional 1,500 participants (n=500 per racial/ethnic group; age 30-49) for a more comprehensive examination of AT(N) defined biomarkers across adulthood among the three largest racial/ethnic groups in the U.S. Core C is responsible for reviewing all data for assignment of research diagnoses (medical and cognitive) as well as providing feedback to participants, families and health care providers as part of our “give back” to the community as indicated during the informed consent process by the participant. The data collected by Core C will be crucial for all Projects and will also be made available to the scientific community via LONI. The Clinical Core Aims are as follows: Aim 1 (Data Capture): In collaboration with all Cores, continue to follow harmonized protocols for the collection, processing, cataloging, storage and distribution of demographic, clinical and imaging data in support of overall program goals. Aim 2 (CSF Substudy): Conduct cerebrospinal fluid (CSF) collection substudy. Aim 3 (Consensus Reviews and Feedback): Continue to conduct consensus reviews to ensure appropriate assignment of research-based clinical diagnoses (cognitive and medical) and provide feedback to participants, families and heath care providers as indicated during informed consent process. Aim 4 (Collaboration): Collaborate with Cores and Projects. Aim 5 (Brain Bank): Build foundation, community relations and infrastructure for future implementation of HABS-HD Brain Bank. Aim 6 (Cross-Study Comparisons): Work collaboratively with other AD+ADRD projects and programs for cross-study comparisons leveraging HABS-HD clinical data. In collaboration with the Administrative Core (Core A), work to ensure cross-study comparisons with ongoing initiatives such as ADNI, WHICAP, SOL/INCA, LEADS, ABC-DS, New IDEAS, ADCs and others.

HABS-HD 临床核心（核心 C）摘要 健康与老龄化大脑研究 – 健康差异 (HABS-HD) 的长期目标是建立一个 针对特定人群的精准医疗，为阿尔茨海默病提供新的治疗和预防策略 NIA AD+ADRD 里程碑 1 中要求的疾病 (AD)。临床核心（核心 C）将通过以下方式实现这一目标： 继续进行所有直接参与者访谈、评估、成像和其他协议组成部分 （母体研究和/或辅助研究）到 U19 启动时，该队列将由 3,000 人组成。 年龄 50 岁及以上的社区居民参与者（n=1,000 名非裔美国人 [AA]、1,000 名墨西哥人 美国人 [MA] 和 1,000 名非西班牙裔白人 [NHW]）访问一次 (V1) 和 24 个月纵向 V2 数据。 在 MA 和 NHW 参与者之间的 U19 启动时可用，并为 AA 提供 V1 数据 作为 U19 参与者的一部分，我们将继续对现有队列进行 24 个月的评估并招募参与者。 另外 1,500 名参与者（n=每个种族/族裔群体 500 人；年龄 30-49 岁），以进行更全面的调查 对美国三个最大种族/族裔群体的整个成年期的 AT(N) 定义的生物标志物进行检查 美国核心 C 负责审查分配研究诊断（医学和认知）的所有数据 以及向参与者、家庭和医疗保健提供者提供反馈，作为我们“回馈”的一部分 参与者在知情同意过程中指出的社区由 Core 收集的数据。 C 对于所有项目都至关重要，并且还将通过 LONI 向科学界提供。 临床核心目标如下： 目标 1（数据采集）：与所有核心合作，继续遵循 人口统计数据收集、处理、编目、存储和分发的统一协议， 支持总体计划目标的临床和影像数据（CSF 子研究）：进行脑脊髓检查。 液体（CSF）收集子研究目标 3（共识审查和反馈）：继续进行共识。 审查以确保基于研究的临床诊断（认知和医学）的适当分配以及 根据知情同意书的指示，向参与者、家庭和医疗保健提供者提供反馈 目标 4（协作）：与核心和项目协作。目标 5（脑库）：建立基础， 未来实施 HABS-HD 脑库的社区关系和基础设施（交叉研究）。 比较）：与其他 AD+ADRD 项目和计划协作进行交叉研究比较 利用 HABS-HD 临床数据 与行政核心（核心 A）合作，努力确保 与正在进行的举措（例如 ADNI、WHICAP、SOL/INCA、LEADS、ABC-DS、New）进行交叉研究比较 想法、ADC 等。