Core B: Clinical Core

核心 B：临床核心

• 批准号: 9977081
• 负责人: Richard J. Caselli
• 金额: $ 74.71万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9977081
• 关键词: Address; Aging; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s Disease Core Center; Alzheimer' s disease brain; Alzheimer' s disease risk; Arizona; Blood specimen; Brain; Brain imaging; Catchment Area; Categories; Cerebrospinal Fluid; Child; Clinic; Clinical; Clinical Research; Cognitive; Colombian; Consensus; Consent; DNA; Data; Data Analyses; Data Set; Dementia; Diagnosis; Diagnostic; Diagnostic tests; Down Syndrome; Early Diagnosis; Eligibility Determination; Enrollment; Evaluation; Fostering; Funding; Genetic; Genetic Diseases; Genetic Risk; Genomics; Genotype; Goals; Health; Health Personnel; Health Sciences; Heterozygote; Homozygote; Impaired cognition; Individual; Institutes; Institution; Intervention; Latino; Lewy Body Dementia; Longitudinal Studies; Magnetic Resonance Imaging; Measures; Medical; Minority Groups; Modeling; Native Americans; Neurologic; Neuropsychology; Normalcy; Participant; Patients; Persons; Plasma; Population; Positron-Emission Tomography; Prevention; Prevention therapy; Procedures; Research; Research Institute; Research Personnel; Research Project Grants; Research Subjects; Resources; Sampling; Scientist; Site; Specialist; Standardization; Structure; Testing; The Sun; Therapeutic Trials; Tissues; Translational Research; Universities; Videoconferences; Work; adjudicate; adjudication; aging brain; apolipoprotein E-4; biomedical referral center; clinical Diagnosis; clinical center; cognitive neuroscience; cohort; cooperative study; data management; design; education research; follow-up; interest; meetings; mild cognitive impairment; mutation carrier; neuroimaging; neuropathology; normal aging; outreach; outreach program; pre-clinical; preclinical study; presenilin-1; prevent; programs; recruit; scientific organization; statistics; symposium; tertiary care; translational neuroscience; tribal leader; young adult

PROJECT SUMMARY/ABSTRACT The Clinical Core (CC) of the Arizona ADCC is a consortium of five recruitment sites providing catchment areas throughout the state that comprise a standardized unit under a single Clinical Core Director. Since its inception, the CC has had an over-arching interest in the study of preclinical Alzheimer's disease (AD) and the accelerated evaluation of AD prevention therapies. It includes a cohort of cognitively unimpaired and annually assessed APOE e4 homozygotes (HMs), heterozygotes, and non-carriers, and has led us to incorporate longitudinal UDS assessments in an independently funded genetically enriched Arizona APOE cohort. CC resources are used to adjudicate their progression to mild cognitive impairment (MCI) and dementia leading to CC enrollment and consent for enrollment into our Brain and Body Donation Program (BBDP). The CC has provided subjects, DNA, longitudinal cognitive data and blood samples to characterize the preclinical course and trajectories of cognitive decline in unimpaired persons at three levels of genetic risk for AD; it has supported our effort to characterize PET, MRI and cerebrospinal fluid (CSF) changes associated with preclinical AD using independent NIA, state and organizational funds. It includes Latino and Native American APOE4 carriers and non-carriers to clarify the relevance of our advances to these understudied populations. It has led to collaborative research in other groups at genetic risk for AD, including children, young adult APOE4 carriers, Colombian presenilin 1 (PSEN1) E280A mutation carriers from the world's largest autosomal dominant AD (ADAD) cohort, and Down syndrome patients. It has provided data to help inform the design, statistical power, and optimized endpoints for our Alzheimer's Prevention Initiative (API) and API's ADAD and APOE4 HM trials. The CC maintains a target of 500 participants at all stages of the aging-dementia spectrum including 350 normal controls, 50 patients with MCI, and 100 with AD and other forms of degenerative dementia. Embedded within these diagnostic categories are defined Latino and Native American cohorts. The CC capitalizes on our multi-institutional diagnostic consensus conference, centralized data management program, and close working relationships with each of the other Cores. All subjects undergo standardized diagnostic testing that: 1) fulfills strict entrance criteria; 2) includes demographic, historical, medical, neurological, psychiatric, neuropsychological, and genetic measures; 3) incorporates the NACC Uniform Data Set (UDS); and 4) employs culturally sensitive test procedures. Patients eligible for enrollment and those completing annual follow-up are discussed in a biweekly diagnostic consensus conference. All undergo APOE genotyping at entry, and an annual standardized neuropsychological battery of tests at all sites. All are offered enrollment in the Brain Donation Program for neuropathological confirmation of clinical diagnoses. Patient eligibility for and participation in ongoing research projects is tracked and reviewed on an ongoing basis.

项目总结/摘要 亚利桑那州ADCC的临床核心（CC）是一个由五个招募网站组成的联盟， 整个州的地区，包括一个标准化的单位下的一个单一的临床核心主任。以来 从一开始，CC就对临床前阿尔茨海默病（AD）的研究产生了浓厚的兴趣， 加速评估AD预防疗法。它包括一个认知未受损的队列， 评估了APOE e4纯合子（HM）、杂合子和非携带者，并使我们将 在独立资助的基因富集亚利桑那州APOE队列中进行纵向UDS评估。CC 资源用于判定他们进展为轻度认知障碍（MCI）和痴呆， CC注册并同意加入我们的大脑和身体捐赠计划（BBDP）。消委会 提供了受试者、DNA、纵向认知数据和血液样本，以表征临床前过程 和轨迹的认知能力下降的未受损的人在三个层次的遗传风险的AD;它有 支持了我们对PET、MRI和脑脊液（CSF）变化的描述， 临床前AD使用独立的NIA，国家和组织基金。它包括拉丁美洲人和美洲原住民 APOE 4携带者和非携带者，以澄清我们的进展与这些研究不足的人群的相关性。它 导致了在其他具有AD遗传风险的群体中的合作研究，包括儿童、年轻成人APOE 4 携带者，哥伦比亚早老素1（PSEN 1）E280 A突变携带者，来自世界上最大的常染色体 显性AD（ADAD）队列和唐氏综合征患者。它提供了数据来帮助设计， 统计功效和我们的阿尔茨海默病预防倡议（API）和API的ADAD的优化终点， APOE 4 HM试验。CC保持了500名参与者的目标，这些参与者处于老年痴呆症谱的各个阶段。 包括350名正常对照，50名MCI患者，100名AD和其他形式的退行性疾病患者。 痴呆在这些诊断类别中嵌入定义的拉丁美洲人和美洲原住民队列。的 CC利用我们的多机构诊断共识会议，集中数据管理 项目，并与其他核心建立密切的工作关系。所有受试者均接受标准化 诊断测试：1）满足严格的入学标准; 2）包括人口统计学，历史，医学， 神经学、精神病学、神经心理学和遗传学指标; 3）纳入NACC统一数据 设置（UDS）;和4）采用文化敏感的测试程序。符合入组条件的患者和 在每两周一次的诊断共识会议上讨论完成年度随访。所有患者均接受APOE 入组时进行基因分型，并在所有研究中心进行年度标准化神经心理学成套测试。所有提供 参加脑捐赠计划，以进行临床诊断的神经病理学确认。患者 持续跟踪和审查参加正在进行的研究项目的资格。