CLINICAL RESEARCH DEVELOPMENT CORE

临床研究开发核心

• 批准号: 7925610
• 负责人: JAMES R BURKE
• 金额: $ 67.78万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7925610
• 关键词: Academia; Alzheimer' s Disease; Alzheimer' s disease risk; Apolipoprotein E; Arts; Autopsy; Behavior assessment; Biogenesis; Biological; Biological Specimen Banks; Blood specimen; Cells; Classification; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical trial protocol document; Collection; Complex; Consent; County; Data; Data Set; Databases; Dementia; Development; Diagnostic; Disease; Education; Enrollment; Environment; Environmental Exposure; Environmental Risk Factor; Epidemiologic Studies; Ethnic group; Evaluation; Factor Analysis; Family; Family history of; Family member; Funding; Future; Genes; Genetic; Genetic Transcription; Genome; Genomics; Goals; Health; Human Genetics; Individual; Industry; Institutes; Investigation; Medical; Medicine; Memory; Memory Disorders; Methods; Minority; Neurocognitive; Neurologic; Operative Surgical Procedures; Participant; Pathologic; Pathology; Patients; Pharmaceutical Preparations; Phenotype; Population; Positioning Attribute; Proteomics; Recording of previous events; Recruitment Activity; Research; Research Personnel; Resources; Risk Factors; Sampling; Science Policy; Specimen; Staging; Symptoms; Syndrome; Therapeutic Clinical Trial; Tissue Banking; Tissue Banks; Twin Studies; Update; Visit; Work; antibody-dependent cell cytotoxicity; base; clinical care; clinical phenotype; data management; disorder control; disorder risk; endophenotype; experience; follow-up; metabolomics; mild neurocognitive impairment; neuroimaging; neuropsychological; normal aging; population based; programs; repository; research and development; statistics

The major aims of the Clinical Core are to accurately phenotype, obtain biological specimens, and longitudinally evaluate subjects with mild neurocognitive disorders facilitating the research efforts of the Bryan ADRC. The Clinical Core's Specific Aims are: 1. Development of a well characterized repository of patients with memory complaints and dementia (Tier I Data Repository) for inclusion in genetic studies and referral into clinical trials and other funded investigations in the Bryan ADRC. Patients to the Memory Disorders Clinic (MDC) are enrolled with consent into a data repository for future studies. This repository is currently comprised of 2500 individuals since yr 2000 and includes a standardized, minimum dataset of health and diagnostic information. 2. Recruit a subset of participants with mild neurocognitive syndromes (Tier II Participants) for detailed genomic medicine studies. Phenotypic characterization includes systematic neurological and neuropsychological evaluations, functional, and behavioral assessments, risk factor enumeration, family history and medication checklists; annual follow-up with medical updates; and collection of blood samples for genetic, transcription, proteomic, and metabolomic studies 3. Build on our history as a Center with strong contributions to genetic and epidemiological studies funded here at Duke (Cache County, NAS Twin's study, Conte Center) to explore the influence of genes and environmental factors in AD risk. 4. Actively encourage and facilitate collaborative studies which draw from the Clinical Core resources of biologic samples and clinical data. Working with the Data Management & Statistics Core, genetic samples and other biological specimens banked at GSK and the IGSP along with detailed clinical data will be made available to researchers at the Bryan ADRC and beyond, including other ADCS and CHG, to promote scientific investigations of AD and related conditions. 5. Continue our successful enrollment and follow-up of participants into the autopsy program, and increase minority enrollment into our research program through our strengthened focus on recruitment. We expect at the end of the next 5 years, to have longitudinally followed a sample of 200 cognitively normal controls and 300 subjects with mild neurocognitive syndromes to augment the existing sample of 150 controls and 475 genetic family members already studied. 6. To expand our participation in collaborative therapeutic clinical trials related to AD with other ADCs and industry. 7. Share clinical data with the National Alzheimer's Coordinating Center (NACC).

临床核心的主要目标是准确的表型，获得生物学 样本，并纵向评估患有轻度神经认知障碍的受试者 布莱恩ADRC的研究努力。临床核心的具体目标是：1.开发一口井 记忆主诉和痴呆症患者的特征存储库(Tier I数据存储库) 在布莱恩纳入基因研究和转介到临床试验和其他资助的研究 ADRC。在同意的情况下，记忆障碍诊所(MDC)的患者被登记到数据存储库 以备将来研究之用。这个储存库目前由2500人组成，自2000年以来 包括一个标准化的健康和诊断信息的最小数据集。2.招募一批 有轻度神经认知综合征的参与者(Tier II参与者)了解详细的基因组医学 学习。表型特征包括系统的神经学和神经心理学 评估、功能和行为评估、风险因素列举、家族病史和 药物清单；每年对最新的医疗情况进行跟踪；收集血液样本 基因、转录、蛋白质组和代谢组学研究3.以我们作为中心的历史为基础 为杜克大学(NAS卡西县)资助的遗传和流行病学研究做出了巨大贡献 TWin的研究，Conte中心)，以探索基因和环境因素在AD风险中的影响。4. 积极鼓励和促进来自临床核心资源的合作研究 生物样本和临床数据。与GSK和IGSP的数据管理和统计核心、遗传样本和其他生物样本合作 与详细的临床数据一起，将向布莱恩ADRC和其他地方的研究人员提供， 包括其他ADC和CHG，以促进对AD和相关疾病的科学研究。5. 继续我们的成功登记和参与者的后续尸检计划，以及 通过加强对以下方面的关注，增加我们研究项目的少数民族招生人数 招聘。我们预计在未来5年结束时，将对200个样本进行纵向跟踪 认知正常的对照组和300名患有轻度神经认知综合征的受试者 已研究的150个对照和475个基因家族成员的现有样本。6.扩大我们的 参与与AD相关的合作治疗临床试验，与其他ADC和行业合作。7. 与国家阿尔茨海默氏症协调中心(NACC)共享临床数据。