Clinical Core

临床核心

基本信息

批准号：
10413094
负责人：
James McCallum Noble
金额：
$ 87.37万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-15 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10413094
关键词：
Address African American population Aging Alzheimer&apos s Disease Alzheimer&apos s Disease Pathway Alzheimer&apos s disease related dementia Area Autopsy Basic Science Biological Biological Markers Blood Blood Cells Blood specimen Brain Brain imaging Caregivers Cells Cerebrospinal Fluid Cessation of life Clinical Clinical Data Clinical Research Clinical Trials Code Collaborations Correlation Studies DNA Data Data Collection Data Coordinating Center Data Element Data Set Database Management Systems Dementia Dementia with Lewy Bodies Diagnosis Diagnostic Disease Enrollment Ensure Environment Evaluation Extramural Activities Family Frontotemporal Dementia Funding Genetic Genetic study Goals Hispanic Populations Image Imaging Device Immunologics Impaired cognition Impairment Individual International Interview Liquid substance Magnetic Resonance Imaging Medical Neurologic Neuropsychological Tests Neuropsychology New York Participant Pathway interactions Patient Recruitments Peripheral Blood Mononuclear Cell Persons Pharmaceutical Preparations Plasma Population Preparation Quality Control Randomized Clinical Trials Research Research Personnel Resource Sharing Resources Sampling Scientist Site Specific qualifier value Specimen Spinal Puncture Students Time Tissues Training Translational Research brain tissue clinical center cohort data cleaning data exchange data management data standards ethnic diversity improved instrument mild cognitive impairment multi-ethnic neuroimaging neuroimmunology neuropathology outreach patient engagement ranpirnase recruit repository research clinical testing skills social symposium training opportunity transmission process

项目摘要

CLINICAL CORE PROJECT SUMMARY/ABSTRACT The Clinical Core is the central component of the P30 Alzheimer’s Disease Research Center (ADRC). The Clinical Core mandate is to provide resources to further the goals of the Center in understanding biological pathways of Alzheimer’s Disease. The Core is a shared resource interacting closely with: the Outreach, Recruitment, and Engagement Core (ORE) Core with regard to recruitment and training; the Database Management and Statistical (DMS) Core with respect to data entry, storage and management; the Neuropathology Core, through arranging brain autopsy and providing relevant correlative clinical data; and the Biomarker, Genetics, and Neuroimmunology Cores through provision of DNA, plasma, blood cells, and cerebrospinal fluid samples for biomarker, genetic, and immunological analyses. The Core will build upon its 29 years as a funded P50 ADRC, during which time it has enrolled more than 6,000 individuals, nearly 1,900 of which are in the NACC Uniform Data Set (UDS) – with ethnic diversity including about 20% Hispanics and 11% African Americans. The P30 Core will enroll 500 individuals in a new cohort: 100 new participants per year, including 25 normal controls, and 75 persons with mild cognitive impairment or dementia. These participants will each have extensive biomarker studies including research-grade 3T MRI, and lumbar puncture for cerebrospinal fluid studies, and be followed annually. The Core will provide data to the DMS Core, transmitted to the National Alzheimer’s Coordinating Center (NACC), and DNA for the Genetics Core, sent to the National Centralized Repository for Alzheimer’s Disease (NCRAD). Evaluations will include detailed medical and neurological interviews and examinations and neuropsychological testing, using NACC and Columbia site- specific instruments. Biomarkers will flow to Biomarker, Genetics, and Neuroimmunology Cores, including blood samples for plasma and peripheral blood cell populations, DNA preparation for genetic studies, CSF specimens for spinal fluid cells and fluid biomarkers, and 3T MRI neuroimaging. The Clinical Core goals include brain autopsies at the time of death, to provide neuropathological samples. The Core coordinates closely with Administrative, Biomarkers, DMS, ORE, Genetics, Neuroimmunology, and Neuropathology Cores, and with the REC module. Participants in the Core are informed of other trials and projects, and encouraged to participate in these important imaging, instrument, drug study, and biomarker trials. The Clinical Core provides training to students, residents, fellows, and investigators. Coded participant data, images, and biological specimens, including plasma, DNA, CSF, and brain tissue are shared with ADRC, and other Columbia and extramural investigators to improve diagnosis, understanding and treatment of aging and dementia, promoting basic and translational research at Columbia, in the New York area, nationwide, and internationally.

临床核心项目总结/摘要临床核心是 P30 阿尔茨海默病研究中心 (ADRC) 的核心组成部分。临床核心任务是提供资源以进一步实现中心在生物学理解方面的目标阿尔茨海默氏病的相互作用途径是与以下机构密切共享的资源：招聘和参与核心 (ORE) 有关招聘和培训的核心；管理和统计（DMS）核心，涉及数据输入、存储和管理；神经病理学核心，通过安排脑部尸检并提供相关的相关临床数据和通过提供 DNA、血浆、血细胞和用于生物标志物、遗传和免疫学分析的脑脊液样本将以其为基础。作为一家受资助的 P50 ADRC 已有 29 年历史，在此期间，它已招募了 6,000 多名个人，其中近 1,900 名位于 NACC 统一数据集 (UDS) 中 – 具有种族多样性，包括约 20% 的西班牙裔和 11% 非裔美国人。P30 核心将在新队列中招募 500 人：每年 100 名新参与者，其中包括 25 名正常对照者和 75 名患有轻度认知障碍或痴呆症的人。每个人都将进行广泛的生物标志物研究，包括研究级 3T MRI 和腰椎穿刺脑脊液研究，并每年进行跟踪，核心将向 DMS 核心提供数据并传输。到国家阿尔茨海默病协调中心 (NACC)，并将遗传核心 DNA 发送到国家阿尔茨海默病协调中心 (NACC) 阿尔茨海默病集中存储库 (NCRAD) 评估将包括详细的医疗和信息。使用 NACC 和哥伦比亚网站进行神经学访谈和检查以及神经心理学测试特定仪器将流向生物标记、遗传学和神经免疫学核心，包括血浆和外周血细胞群的血液样本、遗传研究的 DNA 制备、脑脊液脊髓液细胞和液体生物标志物样本以及 3T MRI 神经影像学目标。包括死亡时的脑部尸检，以提供神经病理学样本。与行政、生物标志物、DMS、ORE、遗传学、神经免疫学和神经病理学核心密切合作，并通过 REC 模块告知核心参与者其他试验和项目，并鼓励他们参与。参与临床核心提供的这些重要的成像、仪器、药物研究和生物标志物试验。对学生、住院医师、研究员和研究人员进行编码的参与者数据、图像和生物信息的培训。样本（包括血浆、DNA、脑脊液和脑组织）与 ADRC 以及其他哥伦比亚和校外研究人员改善衰老和痴呆症的诊断、理解和治疗，促进哥伦比亚大学、纽约地区、全国和国际的基础和转化研究。