Clinical Core

临床核心

• 批准号: 10647864
• 负责人: Victor Henderson
• 金额: $ 88.41万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10647864
• 关键词: Acceleration; Adherence; Adopted; Adult; Age; Aging; Agreement; Alzheimer' s Disease; Alzheimer' s disease pathology; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Amyloid; Amyloid beta-Protein; Behavior assessment; Behavioral; Biological Markers; Brain; Catchment Area; Categories; Clinical; Clinical Trials; Clinical assessments; Cognitive; Cognitive aging; Consensus; Consent; Data; Dementia; Dementia with Lewy Bodies; Development; Diagnosis; Disease; Elderly; Enrollment; Environment; Ethnic Population; Faculty; Family history of; First Degree Relative; Funding; Genetic; Goals; Grant; Hispanic; Image; Immune System Diseases; Impaired cognition; Individual; Latino; Lewy Bodies; Magnetic Resonance Imaging; Measures; Medical Research; Medical Students; Minority Enrollment; Nerve Degeneration; Neurodegenerative Disorders; Neurofibrillary Tangles; Neurologic; Parkinson Disease; Parkinson' s Dementia; Participant; Pathogenesis; Patients; Phenotype; Population; Population Control; Populations at Risk; Positron-Emission Tomography; Protocols documentation; Qualifying; Research; Research Personnel; Research Support; Resistance; Resources; Risk; Therapeutic; Time; Training; Work; alpha synuclein; amyloid imaging; cognitive testing; cohort; education research; follow-up; graduate student; insight; mild cognitive impairment; motor impairment; neuropathology; outreach; participant enrollment; participant retention; pre-clinical; protein misfolding; recruit; resilience; tau Proteins

1. SUMMARY (Clinical Core) In support of the goals of the National Alzheimer's Project Act, the Stanford ADRC will focus on the Alzheimer's disease (AD) spectrum and the Lewy body (LB) spectrum of neurodegenerative cognitive impairment. Recognizing that critical answers will emerge more readily when investigators can delve deeply within and across multiple levels of participant data, we have adopted a strategy of deep phenotyping. Stanford ADRC participants are characterized intensively and followed over time. The AD spectrum includes cognitively impaired patients with AD dementia and mild cognitive impairment due to AD, as well as preclinical AD inferred from biomarker data. The LB spectrum encompasses dementia with Lewy bodies and Parkinson's disease dementia and Parkinson's disease patients with mild cognitive impairment. Healthy adults without cognitive or motor impairment can serve as an age-equivalent comparison population, as an asymptomatic at-risk population, and as a potential preclinical population in which mechanisms of cognitive aging and preclinical transition can be studied. Within the LB spectrum, Parkinson's disease patients without cognitive impairment serve as age-equivalent comparators and as an at-risk transitional population for the development of LB- spectrum cognitive impairment. Stanford ADRC resources will enable the parallel study of these AD and LB spectrum disorders. Opportunities for investigators to compare and contrast can provide unique insights into pathogenesis, resistance and resilience, and therapeutic approaches. The Clinical Core will be responsible for participant enrollment and for clinical, cognitive, and behavioral assessments. In support of a strategy that emphasizes the deep phenotyping of individual participants, the Clinical Core is also responsible for biospecimen procurement, imaging referral, and brain donation consent. It is responsible for participant retention and for longitudinal follow-up. Most new participants in the Stanford ADRC will be asked to provide disease-defining biomarkers measured in CSF, imaged by amyloid-PET/MRI, or both; to consent to longitudinal follow-up; and to agree to brain donation through the Neuropathology Core. The Clinical Core will work with other ADRC Cores to accomplish four aims focused on the AD spectrum and the LB spectrum of neurodegenerative cognitive impairment: (1) Enroll participants into longitudinal research protocols of the Stanford ADRC; characterize their neurological, cognitive, and behavioral status; provide consensus diagnoses; follow participants longitudinally; and promote adherence; (2) support the efforts of other ADRC Cores; (3) support ADRC development project grants and research needs of qualified externally funded investigators who could benefit from Core resources; and (4) support the Research Education Component by providing a rich training environment for medical and graduate students, residents, fellows, and junior faculty.

1.总结（临床核心） 为了支持《国家阿尔茨海默病项目法案》的目标，斯坦福 ADRC 将重点关注 阿尔茨海默病 (AD) 谱和神经退行性认知的路易体 (LB) 谱 损害。认识到当调查人员能够深入研究时，关键答案会更容易出现 在参与者数据的多个级别内和之间，我们采用了深度表型分析策略。斯坦福大学 ADRC 参与者被集中描述并随着时间的推移进行跟踪。 AD 谱系包括认知方面 患有 AD 痴呆和 AD 引起的轻度认知障碍以及临床前推断的 AD 的受损患者 来自生物标志物数据。 LB 谱系包括路易体痴呆和帕金森病 患有轻度认知障碍的痴呆症和帕金森病患者。没有认知能力或 运动障碍可以作为年龄相当的比较人群，作为无症状的高危人群 人群，并作为潜在的临床前人群，其中认知衰老和临床前机制 可以研究过渡。在 LB 谱系中，没有认知障碍的帕金森病患者 作为年龄相当的比较者和LB-发展的高危过渡人群 频谱认知障碍。斯坦福 ADRC 资源将使这些 AD 和 LB 的并行研究成为可能 频谱障碍。研究人员进行比较和对比的机会可以提供独特的见解 发病机制、抵抗力和恢复力以及治疗方法。临床核心将负责 参与者登记以及临床、认知和行为评估。支持一项战略 强调个体参与者的深层表型分析，临床核心还负责 生物样本采购、成像转诊和脑捐赠同意书。它对参与者负责 保留和纵向随访。斯坦福 ADRC 的大多数新参与者将被要求提供 在脑脊液中测量、通过淀粉样蛋白 PET/MRI 成像或两者同时测量的疾病定义生物标志物；同意 纵向随访；并同意通过神经病理学核心进行大脑捐赠。临床核心将 与其他 ADRC 核心合作，实现专注于 AD 频谱和 LB 频谱的四个目标 神经退行性认知障碍：（1）将参与者纳入纵向研究方案 斯坦福大学ADRC；描述他们的神经、认知和行为状态；提供共识 诊断；纵向跟踪参与者；并促进依从性； (2) 支持其他ADRC的努力 核心； (3) 支持ADRC发展项目补助金和符合条件的外部资助的研究需求 可以从核心资源中受益的研究人员； (4) 通过以下方式支持研究教育部分： 为医学生、研究生、住院医师、研究员和初级教师提供丰富的培训环境。