CLINICAL RESEARCH DEVELOPMENT CORE

临床研究开发核心

• 批准号: 7459866
• 负责人: JAMES R BURKE
• 金额: $ 62.33万
• 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/7459866
• 关键词: Academia; Alzheimer' s Disease; Alzheimer' s disease risk; Apolipoprotein E; Arts; Autopsy; Behavior assessment; Biogenesis; Biological; Biological Specimen Banks; Blood specimen; Caring; Cells; Classification; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials, Other; Collection; Complex; Condition; 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; Range; Recording of previous events; Recruitment Activity; Research; Research Personnel; Resources; Risk Factors; Sampling; Science Policy; Specimen; Staging; Symptoms; Syndrome; Therapeutic Clinical Trial; Tissue Banks; Twin Studies; Update; Visit; Work; base; clinical phenotype; data management; disorder control; disorder risk; endophenotype; experience; follow-up; metabolomics; mild neurocognitive impairment; neuroimaging; neuropsychological; normal aging; 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地表型，获得生物学特性， 标本，并纵向评估受试者与轻度神经认知障碍，促进 Bryan ADRC的研究成果。临床核心的具体目标是：1。开发一口井 记忆投诉和痴呆患者的特征化存储库（第一层数据存储库）， 纳入遗传学研究，并转介到临床试验和其他资助的调查，在布赖恩 ADRC。记忆障碍诊所（MDC）的患者在同意的情况下登记到数据存储库中 为将来的研究。自2000年以来，该储存库目前由2500人组成， 包括健康和诊断信息的标准化最小数据集。2.招募一部分 患有轻度神经认知综合征的受试者（II级受试者），以获得详细的基因组医学 问题研究表型表征包括系统神经学和神经心理学 评估、功能和行为评估、危险因素计数、家族史和 药物检查表;年度医疗更新随访;采集血液样本， 遗传、转录、蛋白质组学和代谢组学研究3.以我们的历史为基础， 在杜克大学（NAS的卡奇县），我对遗传学和流行病学研究做出了巨大的贡献 Twin的研究，Conte中心），以探讨基因和环境因素在AD风险中的影响。4. 积极鼓励和促进利用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、基因样本和其他生物样本库合作 沿着详细的临床数据将提供给布莱恩ADRC及其他机构的研究人员， 包括其他ADCS和CHG，以促进AD和相关疾病的科学研究。5. 继续我们成功的招募和随访参与者进入尸检计划， 增加少数民族入学到我们的研究计划，通过我们加强重点， 招聘我们预计在未来5年结束时，将纵向跟踪200个样本， 认知正常的对照组和300名轻度神经认知综合征的受试者， 现有的150个对照和475个遗传家族成员的样本已经研究过。6.扩大我们 参与与其他ADC和行业合作的AD相关治疗临床试验。7. 与国家阿尔茨海默氏症协调中心（NACC）共享临床数据。