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 临床核心从临床和神经心理学角度描述并纵向跟踪一组 认知正常的老年对照 (NC) 受试者和阿尔茨海默病 (AD) 患者，轻度认知 损伤 (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。它还储存生物样本（例如， 来自这些受试者的血浆、DNA、成纤维细胞、脑脊液）并促进尸检。过去 30 年来， Core 提供了特征明确的受试者、临床和认知数据以及生物样本 地方、国家和国际研究为检测领域的巨大进步做出了贡献 AD 处于最早（甚至临床前）阶段，AD 与其他痴呆症的鉴别诊断，跟踪 随着时间的推移，AD 的病程，并测试 AD 的新治疗方法。临床的具体目标 核心是： (1) 维持并关注由约 500 名擅长英语或西班牙语的专家组成的小组 患有 AD、MCI、DLB/PDD 或 FTD 的受试者，以及年龄和教育程度匹配的 NC 受试者。 (2) 维持 尸检率高（即大于75%）。 （3）每年进行详细、规范的护理， 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估 补充程序。 (4) 维持和增加患有以下疾病的受试者的血浆、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 ADNI 中其他 ADC 的项目， 以及 AD 的多中心治疗药物试验。 (8) 细化和评估临床和神经心理学 准确识别从正常认知到临床前 AD 转变的评估程序 到 MCI 到非常轻度的 AD 痴呆。 (9) 完善和评估临床、神经心理学和实验室 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，检查新的神经心理学 早期发现 AD、评估主观记忆和其他认知问题的方法，以及评估 参与初级预防临床试验的态度和潜在障碍。这将通过以下方式得到增强 新招募认知正常但 AD 风险增加的老年人（由于年龄和 APOE 基因型） 并愿意接受典型的 AD 试验程序（包括神经影像学、血浆和脑脊液检查） 生物标志物）。该队列将为未来小学入学提供重要的生态有效性 预防临床试验。