1Florida Alzheimer's Disease Research Center Clinical Core

1佛罗里达阿尔茨海默病研究中心临床核心

• 批准号: 10663218
• 负责人: Melissa Jo Armstrong
• 金额: $ 140.08万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663218
• 关键词: Acculturation; Affect; African American; Alzheimer' s Disease; Alzheimer' s disease related dementia; Amyloid; Amyloid beta-42; Autopsy; Biological Markers; Blood Vessels; Brain; Brain Pathology; Brain region; Classification; Clinical; Clinical Trials; Cognition; Cognitive; Collaborations; Communities; Complement; Consent; Data; Dementia; Diagnosis; Diagnostic; Disease; Early Diagnosis; Education; Elderly; Elements; Enrollment; Ensure; Epidemiology; Evaluation; Florida; Funding; Genetic; Genotype; Goals; Hispanic; Hispanic Populations; Image; Impaired cognition; Individual; Investigation; Language; Lewy Body Disease; Longitudinal Studies; MRI Scans; Magnetic Resonance Imaging; Medical center; Methodology; Methods; Minority Groups; Monitor; National Institute on Alcohol Abuse and Alcoholism; Nerve Degeneration; Neuropsychological Tests; Neuropsychology; Not Hispanic or Latino; Parkinson Disease; Parkinsonian Disorders; Participant; Pathology; Performance; Phenotype; Positron-Emission Tomography; Protocols documentation; Qualifying; Research; Research Activity; Research Personnel; Research Project Grants; Site; Standardization; Training; Underrepresented Minority; Universities; Vascular Dementia; Vascular Diseases; bilingualism; blood-based biomarker; cerebrovascular; clinical center; clinical research site; cognitive change; cohort; comorbidity; disparity reduction; ethnic diversity; follow-up; improved; instrument; mild cognitive impairment; neuroimaging; neuropathology; novel; preclinical study; racial diversity; recruit; research study; retention rate; success; tau Proteins

The goal of the 1Florida ADRC is to advance the understanding of Alzheimer’s disease and Related Disorders (ADRDs), especially in underrepresented minority groups. Among 370 participants currently recruited at Mount Sinai Medical Center (MSMC), 60% are Hispanic, with a retention rate of ~80%, over 50% are normal or have various stages of Mild Cognitive Impairment (MCI). Structural MRI has been obtained on 90% and amyloid PET (aPET) scans on ~70% of participants (comprising 1/3 of all aPET scans in NACC). Autopsy has been obtained on over 95% of those consented, including > 50% from Hispanic decedents. Novel neuropsychological instruments in English and Spanish have been developed and utilized to detect cognitive impairment before it is detectable by standard assessments. The effects of language, culture, acculturation and bilingualism among minority groups on cognitive and functional performance, the demographic and genetic factors that affect the threshold for amyloid positivity and the differential effect of APOE genotype on amyloid load in Hispanics versus non-Hispanics have been studies in depth. In the current P30 application, we propose to expand the clinical core to include MSMC as well as University of Miami (UM), where recruitment and retention of AA participants has been very successful and expertise in evaluating vascular comorbidities and contributions to dementia exists, and the University of Florida (UF), Gainesville, where considerable expertise exists in evaluation and studies of Lewy Body Disease (LBD) and early Parkinson’s disease. In total we propose to recruit 600 participants (~40% Hispanic, ~40% White non- Hispanic [WNH], and ~20% AA), including 100 new participants at each of three sites and at least 200 follow- ups at MSMC and 100 follow-ups each at UM and UF. All new participants will receive MRI and aPET scans. Follow-up participants will also receive repeat MRI scans and most will receive aPET scans. Blood-based biomarker assessments (Aβ42:40, NFL, and others) will be used to complement the imaging and neuropsychological assessments. Clinical Core activities will be integrated closely with ORE, REC, Biomarker and Pathology Cores, and harmonized across the three clinical sites with respect to consistency of assessments, biospecimens, biomarker studies, standardized implementation of all NACC modules, LBD and vascular assessments diagnostic methodology. Utilization of elements of the NIA-AA Research Framework ATN classification (Amyloid, Tau, Neurodegeneration) will be implemented. Methods and metrics will be used to ensure full integration between the sites, including recruitment and enrollment for brain autopsies, which will be done at all three sites, with correlation of imaging findings to regional brain pathology and structural changes. Qualified investigators and the larger ADRD community will receive access to Clinical Core participants and their data and biospecimens for research projects and education, training purposes.

1佛罗里达 ADRC 的目标是增进对阿尔茨海默病和相关疾病的了解 （ADRD），特别是在代表性不足的少数群体中。目前在 Mount 招募的 370 名参与者中 西奈医疗中心 (MSMC)，60% 是西班牙裔，保留率约为 80%，超过 50% 是正常人或有 轻度认知障碍 (MCI) 的各个阶段。已获得 90% 的结构 MRI 和淀粉样蛋白 PET (aPET) 扫描约 70% 的参与者（占 NACC 中所有 aPET 扫描的 1/3）。尸检已获得 超过 95% 的人表示同意，其中超过 50% 的人来自西班牙裔后裔。新颖的神经心理学 英语和西班牙语的工具已经开发出来并用于在认知障碍出现之前对其进行检测 可通过标准评估检测到。语言、文化、文化适应和双语的影响 少数群体的认知和功能表现、影响的人口和遗传因素 淀粉样蛋白阳性阈值以及 APOE 基因型对西班牙裔和西班牙裔淀粉样蛋白负荷的差异影响 对非西班牙裔人进行了深入研究。 在当前的 P30 应用中，我们建议将临床核心扩展到包括 MSMC 以及 University of 迈阿密（UM），AA 参与者的招募和保留非常成功，并且在 佛罗里达大学 (UF) 正在评估血管合并症及其对痴呆症的影响， 盖恩斯维尔，在路易体病 (LBD) 的评估和研究方面拥有丰富的专业知识和 早期帕金森病。我们总共建议招募 600 名参与者（~40% 西班牙裔，~40% 非白人） 西班牙裔 [WNH]，约 20% AA），包括三个地点各 100 名新参与者以及至少 200 名后续参与者 MSMC 进行了 100 次随访，UM 和 UF 各进行了 100 次随访。所有新参与者都将接受 MRI 和 aPET 扫描。 后续参与者还将接受重复的 MRI 扫描，大多数人将接受 aPET 扫描。以血液为基础 生物标志物评估（Aβ42:40、NFL 等）将用于补充成像和 神经心理学评估。 临床核心活动将与 ORE、REC、生物标志物和病理学核心紧密结合， 三个临床中心在评估、生物样本、生物标志物的一致性方面进行了协调 研究、所有 NACC 模块、LBD 和血管评估诊断的标准化实施 方法论。利用 NIA-AA 研究框架 ATN 分类的要素（淀粉样蛋白、Tau、 神经退行性疾病）将被实施。将使用方法和指标来确保之间的充分集成 这些地点，包括脑部尸检的招募和登记，这将在所有三个地点进行， 成像结果与区域脑病理学和结构变化的相关性。合格的调查员和 更大的 ADRD 社区将获得临床核心参与者及其数据和生物样本的访问权限 用于研究项目和教育、培训目的。