Clinical Core

临床核心

• 批准号: 10615163
• 负责人: DOUGLAS R GALASKO
• 金额: $ 99.71万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10615163
• 关键词: Address; Adopted; Age; Aging; Agreement; Alzheimer' s Disease; Alzheimer' s disease related dementia; Area; Autopsy; Biochemical; Biological Markers; Biopsy; Blood; Blood specimen; Brain; Brain Chemistry; Brain imaging; Cells; Cessation of life; Classification; Clinical; Clinical Research; Cognition; Cognitive; Cognitive aging; Consent; DNA; Data; Data Set; Databases; Dementia; Diagnosis; Disease; Early Diagnosis; Elderly; Enrollment; Environment; Excision; Frontotemporal Lobar Degenerations; Funding; Genetic; Heterogeneity; Hippocampus; Human Microbiome; Image; Latino; Latino Population; Lewy Body Disease; Link; Magnetic Resonance Imaging; Measures; Medical Genetics; Memory; Methodology; Mexican Americans; Minority Enrollment; Neurodegenerative Disorders; Participant; Pathology; Persons; Phenotype; Physiological; Plasma; Pluripotent Stem Cells; Population; Positron-Emission Tomography; Quality Control; Registries; Research; Research Support; Sampling; Serum; Skin; Spinal Puncture; Staging; Structure; Symptoms; Testing; United States National Institutes of Health; Variant; Work; aging brain; alpha synuclein; biomarker evaluation; cell transformation; clinical phenotype; clinical trial recruitment; clinically significant; cognitive testing; cohort; data management; data sharing; dementia risk; follow-up; hazard; hippocampal sclerosis; indexing; induced pluripotent stem cell; innovation; interest; meetings; member; metabolomics; mild cognitive impairment; minority subjects; neuropathology; novel; novel marker; outreach; pre-clinical; recruit; response; social; symposium; tau Proteins; volunteer

CLINICAL CORE SUMMARY/ ABSTRACT The primary aim of the Clinical Core will be to enroll, characterize and follow a cohort maintained at 500-600 elders to support many types of research into Alzheimer’s Disease and Related Disorders. People who are enrolled will include some with normal cognition, some of whom may have markers of Alzheimer’s in their brain already, people with mild cognitive impairment and mild Alzheimer’s, and people with other types of neurodegenerative disorders, including Lewy Body Disease and Fronto-Temporal Lobar Degeneration. The core will enroll minority subjects as part of the groups that are followed, in particular Latinos. In addition to collecting and storing data about the ADRC participants at UCSD, the core will include components that are part of a national effort across centers, called the Uniform Data Set (UDS). The Core will submit UDS data on all subjects it follows to the national Alzheimer’s Coordinating Center (NACC). This will allow data sharing with a large national database. The Clinical Core will perform further testing beyond the tests required for the UDS. The core will draw a sample of blood for DNA, plasma and serum from participants, and will obtain CSF samples by lumbar puncture from those who agree. The core will obtain skin biopsies to be used to transform the cells in the skin into cells that can change into many identities (called pluripotent stem cells). Participants will have MRI brain imaging and PET imaging to support research into brain changes and pathology. Blood, CSF, skin biopsies and imaging will be stored at UCSD to allow for further analysis, and it may be available to share with collaborators. All participants will be invited to undergo follow-up research assessments once per year, to determine change in brain functioning, memory and other abilities. In subjects who consent, after their death the core will arrange for autopsy removal of the brain, for pathology analysis and to support further research. Some of the particular areas where the core will focus its efforts are in novel cognitive tests and assessing the brain through biomarkers related to structure, function, pathology and chemistry of the brain. This may help in early detection of change before major symptoms of dementia have arisen. Alzheimer’s disease has different features and progresses at varying rates, and we will try to identify factors that may account for this variation. Another area of interest for the core is in developing better ways to assess Latino participants, supported through social, cultural, and research expertise of the Latino Core. Finally, the core will work with other members of the ADRC to maintain and expand a Registry of research- ready volunteers.

临床核心总结/摘要 临床核心研究的主要目的是招募、表征和随访维持在500-600的队列 老年人支持对阿尔茨海默病和相关疾病的多种类型的研究。的人 参加的人将包括一些认知正常的人，其中一些人的大脑中可能有阿尔茨海默氏症的标记 已经有轻度认知障碍和轻度阿尔茨海默氏症患者，以及其他类型的 神经退行性疾病，包括路易体病和额颞叶变性。的 核心将招收少数民族科目作为被跟踪的群体的一部分，特别是拉丁美洲人。 除了收集和存储有关加州大学圣地亚哥分校ADRC参与者的数据外，核心还包括 这些组件是跨中心的国家努力的一部分，称为统一数据集（UDS）。芯会 将所有受试者的UDS数据提交给国家阿尔茨海默氏症协调中心（NACC）。这将 允许与大型国家数据库共享数据。临床中心将在 UDS所需的测试。 核心将从参与者中抽取血液样本用于DNA、血浆和血清，并将获得CSF 从同意的人身上进行腰椎穿刺。核心将获得皮肤活检，用于转化 将皮肤中的细胞转化为可以转变为多种身份的细胞（称为多能干细胞）。参与者 将有MRI脑成像和PET成像，以支持对大脑变化和病理学的研究。鲜血， CSF、皮肤活检和成像将储存在UCSD，以进行进一步分析， 与合作者分享。 所有参与者将被邀请每年进行一次后续研究评估，以确定 大脑功能、记忆力和其他能力的改变。在同意的受试者中，在他们死后， 安排进行脑部解剖、病理分析和支持进一步研究。 核心将集中精力的一些特定领域是新颖的认知测试和评估 通过与脑的结构、功能、病理学和化学相关的生物标志物来研究脑。这可以帮助 在痴呆症的主要症状出现之前及早发现变化。老年痴呆症有不同的 特征和进展以不同的速度，我们将试图确定可能导致这种变化的因素。 核心感兴趣的另一个领域是开发更好的方法来评估拉丁美洲参与者， 通过社会，文化，和研究的拉丁美洲核心的专业知识。 最后，核心将与ADRC的其他成员合作，维护和扩大研究登记册- 志愿者准备