South Texas Alzheimer's Disease Center Clinical Core

南德克萨斯阿尔茨海默病中心临床核心

• 批准号: 10662340
• 负责人: GABRIEL Alejandro DE ERAUSQUIN
• 金额: $ 61.15万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10662340
• 关键词: Acceleration; Acculturation; Affect; Alzheimer' s Disease; Alzheimer' s disease pathology; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Amyloid; Apolipoprotein E; Autopsy; Biological; Biological Assay; Biological Markers; Biology; Blood; Blood Vessels; Caregivers; Caring; Clinic; Clinical; Clinical Research; Clinical Trials; Cognitive; Cognitive aging; Collaborations; Collection; Comprehensive Health Care; Consent; Data; Data Collection; Data Set; Dementia; Diabetes Mellitus; Diagnosis; Diet; Disease; Disease Progression; Education; Elements; Eligibility Determination; Enrollment; Ensure; Environment; Ethnic Origin; Family; Gait; Genetic; Genomics; Genotype; Geography; Health; Hearing; High Prevalence; Hispanic Populations; Image; Individual; Life Style; Magnetic Resonance Imaging; Measures; Medical; Mexican Americans; Minority; Moods; Motor; Neurologic; Neurosciences; Outcome; Participant; Pathologic; Pathology; Patient Care; Patients; Pennsylvania; Persons; Phase; Phenotype; Physical activity; Population; Positron-Emission Tomography; Prevalence; Preventive Clinical Trial; Process; Prognosis; Protocols documentation; Race; Recording of previous events; Registries; Research; Risk; Risk Factors; Sampling; Sensory; Site; Sleep; Social support; South Texas; Syndrome; Testing; Translational Research; United States; Vision; Visit; advanced dementia; behavior measurement; bilingualism; biobank; biomarker identification; biotypes; brain morphology; care outcomes; clinical center; cohort; comorbidity; data management; data quality; data sharing; dementia care; dementia risk; diagnostic criteria; genome wide association study; health care availability; high risk; hispanic community; imaging biomarker; improved; machine learning method; multiple omics; neuroimaging; neuropathology; novel; novel marker; observational cohort study; outreach; precision medicine; primary caregiver; recruit; resilience; resilience factor; risk stratification; rural residence; social; social determinants; socioeconomics; tau Proteins; trial readiness; underserved area; underserved community; vascular factor; vascular risk factor; web site

Abstract The Mexican-American (MA) Hispanic community is the most rapidly growing minority and is disproportionately affected by Alzheimer’s disease and related dementias (ADRDs). Nonetheless, the prevalence, predictors, biology and clinical course of dementia, and the care needs of this population remain understudied. The Clinical Core (CC) of the South Texas Alzheimer Center (STAC) will establish a new culturally, socioeconomically, and geographically diverse cohort in this underserved region. Recruitment will be done at 3 core sites (San Antonio, Laredo and Harlingen, TX) using identical protocols. The CC will collect all the prescribed Uniform Dataset (UDS) data and collaborate with the Imaging (IC), Biomarker (BC), Genetics and Multiomics (GMC) and Neuropathological (NPC) cores to establish the brain morphology (ADNI3 protocol MRI, amyloid and tau PET), biomarker (blood, CSF, sensory-motor), genomic (clinical tests, APOE, GWAS, WGS) and pathological correlates of clinical syndromes to advance our understanding of the heterogeneous pathophysiological processes underlying ADRDs, especially in MA, using precision medicine approaches. In partnership with the Population Neuroscience Core (PNC), the CC will define risk and resilience factors for dementia by examining the impact of vascular, lifestyle, medical comorbidities, environment, culture, and social determinants (UDS+ data) on the transition from normal cognitive aging to dementia. In addition, the CC will create a trial-ready caregiver registry, examine a caregiver sample (same tests as patients except for PET and LP), and will study the interactional effect of the patient/caregiver dyad on disease course, care needs, and health outcomes. The CC will annually enroll 140 individuals with MCI or dementia and 60 cognitively normal controls; >50% will be of MA ancestry and at least 30% from underserved areas to establish a diverse longitudinal clinical cohort of ~700- 800 persons by year 4 (Aim 1a). The CC will also recruit all care partners of individuals in the clinical cohort into the caregiver registry and intensively study all willing caregivers, ~45/year from dyad and ~20 who provide care to ADRD patients who may be too advanced to enroll (Aim 1b). Within these cohorts, the CC will assess the prevalence of novel and established ADRD biomarkers of pathology, risk, and resilience with disease course and prognosis (Aim 2a). The CC will provide comprehensive care throughout illness, enabling deep longitudinal phenotyping and annual collection of biospecimens (BC, NPC), assessing serial change in imaging (IC), and clinicopathological correlations at autopsy (NPC). The approach will promote engagement (OREC), education (REC), and clinical trials for all disease stages (Aim 2b). The CC will also genetically characterize the cohort (Aim 3) and identify biomarkers for biological characterization of Suspected Non-Alzheimer Pathology (SNAP, A-/N+) in persons with and without diabetes (Aim 4). The DMSC will ensure timely, quality data collection and sharing. In summary, the CC will identify risk/resilience factors, utilize precision medicine approaches to improve risk-stratification, diagnosis, and prognosis, and enhance research recruitment of a predominantly MA cohort.

抽象的 墨西哥裔美国人 (MA) 西班牙裔社区是增长最快的少数族裔，并且比例过高 然而，受阿尔茨海默病和相关痴呆症（ADRD）的影响，患病率、预测因素、 痴呆症的生物学和临床病程以及该人群的护理需求仍未得到充分研究。 南德克萨斯阿尔茨海默病中心 (STAC) 的核心 (CC) 将建立一个新的文化、社会经济和 该服务欠缺地区的不同地理位置的群体将在 3 个核心地点（圣安东尼奥、圣安东尼奥）进行招募。 拉雷多和哈林根，德克萨斯州）使用相同的协议，CC 将收集所有规定的统一数据集 (UDS)。 数据并与成像 (IC)、生物标记 (BC)、遗传学和多组学 (GMC) 以及 神经病理学 (NPC) 核心，用于建立大脑形态（ADNI3 协议 MRI、淀粉样蛋白和 tau PET）， 生物标志物（血液、脑脊液、感觉运动）、基因组（临床测试、APOE、GWAS、WGS）和病理学 临床综合征的相关性，以增进我们对异质病理生理学的理解 ADRD 的基本流程，特别是在 MA 中，与精准医学方法合作。 人口神经科学核心 (PNC)，CC 将通过检查来定义痴呆症的风险和恢复因素 血管、生活方式、医疗合并症、环境、文化和社会决定因素的影响 (UDS+ 数据）此外，CC 将创建一个可供试验的模型。 护理人员登记，检查护理人员样本（除 PET 和 LP 外与患者进行相同的测试），并将研究 患者/护理人员二人组对病程、护理需求和健康结果的相互作用。 CC 每年将招募 140 名患有 MCI 或痴呆症的患者，以及 60 名认知正常的对照组； MA 血统和至少 30% 来自服务不足地区，以建立约 700 名纵向多样化临床队列 到第 4 年将招募 800 人（目标 1a）。CC 还将招募临床队列中个人的所有护理伙伴。 护理人员登记处并深入研究所有自愿护理人员，每年约 45 名护理人员，约 20 名提供护理的人员 对于可能因病情太重而无法入组的 ADRD 患者（目标 1b），CC 将评估这些患者的情况。 新型和已确定的 ADRD 病理学、风险和恢复力生物标志物的流行率随病程的变化 和预后（目标 2a）。CC 将在整个疾病过程中提供全面的护理，从而实现深入的纵向治疗。 表型分析和生物样本（BC、NPC）的年度收集，评估成像（IC）的系列变化，以及 尸检（NPC）中的临床病理学相关性该方法将促进参与（OREC）和教育。 (REC) 以及所有疾病阶段的临床试验 (目标 2b)，CC 还将对队列进行基因表征。 （目标 3）并确定疑似非阿尔茨海默病病理学生物学特征的生物标志物（SNAP， A-/N+）适用于糖尿病患者和非糖尿病患者（目标 4）。DMSC 将确保及时、高质量的数据收集和评估。 总之，CC 将识别风险/弹性因素，利用精准医学方法来改善。 风险分层、诊断和预后，并加强主要 MA 队列的研究招募。