Clinical Core

临床核心

• 批准号: 8676142
• 负责人: DOUGLAS R GALASKO
• 金额: $ 92.69万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8676142
• 关键词: Activities of Daily Living; Age; Alzheimer disease detection; Alzheimer' s Disease; Alzheimer' s disease risk; Area; Attitude; Autopsy; Biological; Biological Markers; Biological Specimen Banks; Clinical; Clinical Data; Clinical Research; Cognition; Cognitive; Consent; Correlation Studies; DNA; Data; Data Coordinating Center; Data Set; Dementia; Development; Diagnosis; Diagnostic; Differential Diagnosis; Disease; Early Diagnosis; Education; Effectiveness; Elderly; Enrollment; Evaluation; Fibroblasts; Frontotemporal Dementia; Funding; Future; Genetic; Genotype; Goals; Image; Information Dissemination; Interdisciplinary Study; International; Laboratories; Lewy Body Dementia; Memory; Neurological Nursing; Neuropsychological Tests; Parkinson' s Dementia; Participant; Pathology; Patients; Pharmaceutical Preparations; Pilot Projects; Plasma; Primary Prevention; Procedures; Protocols documentation; Research; Research Personnel; Research Project Grants; Research Subjects; Research Support; Resources; Specimen; Spinal Puncture; Staging; TNFRSF5 gene; Testing; Therapeutic; Time; Tissues; Work; abstracting; clinical Diagnosis; cohort; data management; innovation; meetings; mild cognitive impairment; neuroimaging; neuropathology; neuropsychological; novel; pre-clinical; prevention clinical trial; research clinical testing; statistics; tool; willingness

CORE B: CLINICAL - ABSTRACT The Clinical Core clinically and neuropsychologically characterizes, and longitudinally follows, a cohort of cognitively-normal elderly control (NC) subjects and patients with Alzheimer's disease (AD), Mild Cognitive Impairment (MCI), Dementia with Lewy bodies (DLB), Parkinson's disease with dementia (PDD), Frontotemporal dementia (FTD) or other dementing disorders. It also banks biological specimens (e.g., plasma, DNA, fibroblasts, CSF) from these subjects and facilitates autopsy. Over the past 30 years, the Core has provided well-characterized subjects, clinical and cognitive data, and biological specimens to local, national and international research that has contributed to great progress in the areas of detection of AD in its earliest (even pre-clinical) stages, differential diagnosis of AD from other dementias, tracking the course of AD over time, and testing new treatment approaches for AD. The Specific Aims of the Clinical Core are to: (1) Maintain and follow a panel of about 500 well characterized English- or Spanish-speaking subjects with AD, MCI, DLB/PDD, or FTD, and age- and education-matched NC subjects. (2) Maintain a high autopsy rate (i.e., greater than 75%). (3) Perform annual detailed and standardized nursing, neurological, and neuropsychological evaluations of all subjects using Uniform Data Set (UDS) and supplemental procedures. (4) Maintain and augment banks of plasma, DNA, and CSF from subjects with AD, MCI, DLB/PDD and healthy controls. (6) Share clinical data with the NACC UDS and with investigators performing other multi-center analyses of clinical data. (7) Participate in projects with other ADCs, in ADNI, and in multi-center therapeutic drug trials for AD. (8) Refine and evaluate clinical and neuropsychological assessment procedures for accurate identification of the transition from normal cognition and pre-clinical AD to MCI to very mild AD dementia. (9) Refine and evaluate clinical, neuropsychological, and laboratory assessment procedures to differentiate AD from DLB/PDD, FTD, and other dementing disorders. The Core will also engage in innovative developmental research that will examine novel neuropsychological approaches to early detection of AD, assess subjective memory and other cognitive complaints, and assess attitudes and potential barriers to participation in primary prevention clinical trials. This will be enhanced by new recruitment of cognitively normal elderly with increased risk of AD (due to age and APOE genotype) and willingness to undergo typical AD trial procedures (including neuroimaging and plasma and CSF biomarkers). This cohort will provide important ecological validity in relation to enrollment for future primary prevention clinical trials.

核心B：临床-摘要 临床核心的临床和神经心理学特征，并纵向如下，一个队列， 认知正常的老年对照（NC）受试者和患有阿尔茨海默病（AD）、轻度认知障碍（AD）和轻度认知障碍（AD）的患者。 障碍（MCI）、路易体痴呆（DLB）、帕金森病伴痴呆（PDD）， 额颞叶痴呆（FTD）或其他痴呆症。它还储存生物标本（例如， 血浆、DNA、成纤维细胞、CSF），并便于尸检。在过去的30年里， Core提供了特征良好的受试者、临床和认知数据以及生物标本， 地方、国家和国际的研究，为发现艾滋病毒/艾滋病领域的重大进展做出了贡献。 AD的早期（甚至临床前）阶段，AD与其他痴呆的鉴别诊断，跟踪 随着时间的推移，AD的过程中，并测试新的治疗方法，为AD。临床的具体目标 核心是：（1）保持和遵循约500名讲英语或西班牙语的人组成的小组 AD、MCI、DLB/PDD或FTD受试者以及年龄和教育匹配的NC受试者。(2)保持 高尸检率（即，大于75%）。(3)实施年度细致化、规范化护理， 使用统一数据集（UDS）对所有受试者进行神经学和神经心理学评价， 补充程序。(4)维护和增加受试者的血浆、DNA和CSF库， AD、MCI、DLB/PDD和健康对照。(6)与NACC UDS和研究者共享临床数据 对临床数据进行其他多中心分析。(7)参与其他ADC的项目，在ADNI， 以及AD的多中心治疗药物试验。(8)完善和评估临床和神经心理学 用于准确识别从正常认知和临床前AD转变的评估程序 从轻度认知障碍到非常轻微的AD痴呆(9)完善和评估临床、神经心理学和实验室检查 区分AD与DLB/PDD、FTD和其他痴呆症的评估程序。核心 还将从事创新的发展研究，将检查新的神经心理学 早期检测AD的方法，评估主观记忆和其他认知主诉，并评估 参与初级预防临床试验的态度和潜在障碍。这将得到加强， 新招募的认知正常老年人，AD风险增加（由于年龄和APOE基因型） 并且愿意接受典型的AD试验程序（包括神经影像学和血浆和CSF 生物标志物）。该队列将为未来的小学入学提供重要的生态有效性 预防临床试验。