Clinical Core

临床核心

• 批准号: 9353007
• 负责人: NED C SACKTOR
• 金额: $ 36.42万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-16 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9353007
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Age; Animals; Anti-Inflammatory Agents; Anti-inflammatory; Area; Baltimore; Behavioral; Biological Markers; Cellular Stress; Cerebrospinal Fluid; Clinical; Clinical Data; Clinical Research; Clinical Treatment; Clinical Trials; Cognition Disorders; Collaborations; Conduct Clinical Trials; Cost Savings; Data; Development; District of Columbia; Drug Targeting; Energy Metabolism; Ensure; Epidemic; Evaluation; Fluconazole; Functional Magnetic Resonance Imaging; Functional disorder; Funding; Glutamates; Goals; Grant; HIV; HIV Infections; HIV Seronegativity; HIV-associated neurocognitive disorder; Human immunodeficiency virus test; Impaired cognition; In Vitro; Individual; Infection; Institution; Insulin; Intervention; Laboratories; Laboratory Markers; Link; Magnetic Resonance Spectroscopy; Maintenance; Measures; Mental Health; Modeling; Multicenter Studies; National Institute of Mental Health; Neurocognitive; Neurocognitive Deficit; Neurologic; Neuromodulator; Neuronal Injury; Neuropsychological Tests; Neuropsychology; Optical Coherence Tomography; Outcome; Outcome Measure; Oxidative Stress; Paroxetine; Participant; Patients; Performance; Persons; Phase; Plasma; Play; Positron-Emission Tomography; Prevalence; Recruitment Activity; Regulation; Research Infrastructure; Research Institute; Resource Sharing; Resources; Risk Behaviors; Role; SIV; Safety; Sample Size; Services; Source; Specific qualifier value; Specimen; Sphingomyelinase; Therapeutic; Translating; Translational Research; Uganda; Universities; anakinra; base; clinical biomarkers; cohort; demographics; drug discovery; immune activation; improved; indexing; neuroimaging; neuroprotection; neuroregulation; novel; novel therapeutics; pre-clinical; research clinical testing; screening; therapeutic development; therapeutic target; therapy development; treatment response

PROJECT SUMMARY - CLINICAL CORE The prevalence of HAND in HIV+ individuals with advanced infection remains around 40-50%, and HAND may now be the most common form of young-age neurocognitive impairment globally. Currently there are no uniformly accepted clinical, neuroimaging, or laboratory outcome measures for clinical trials for the treatment of HAND. This Core provides the support necessary to evaluate new outcome measures of CNS function including both neurocognitive assessments (e.g., screening tests for HAND) and performance based functional assessments. In addition, the Core will provide well-characterized individuals for developmental projects such as novel neuroimaging outcomes which may be more sensitive to CNS dysfunction and response to treatment than neuropsychological test measures. The Clinical Core will also provide well-characterized individuals for evaluating novel laboratory markers identified in the Biomarker Core. Specifically, we will examine markers of cell stress, neuronal injury, and energy metabolism, which are also being used as platforms for therapeutic targets in our Therapeutic Core. The goals and objectives of this Core are as follows: 1) To maintain a clinical cohort of well-characterized HIV+ and demographically-matched HIV- individuals to improve the efficiency of accruing and conducting clinical trials, 2) To liaise with other NIMH Centers, other funded IPCPs, the AIDS Clinical Trials Group (ACTG), the Johns Hopkins University Center for AIDS Research (JHU CFAR), Institute for Clinical and Translational Research (ICTR), and the Johns Hopkins University (JHU) Drug Discovery unit to assist in the development of interventional therapeutics for HAND, 3) To provide the infrastructure and resources necessary to conduct small early phase studies to evaluate therapeutics for HAND including novel drugs, neuromodulation and behavioral strategies, 4) To maintain a data infrastructure to allow for efficient querying of clinical and laboratory data, 5) To provide statistical support for all studies involving the Center Grant resources.

项目总结-临床核心 HAND在晚期感染的HIV+个体中的患病率保持在40- 50%左右，HAND可能 现在是全球最常见的老年神经认知障碍形式。目前没有 用于治疗以下疾病的临床试验的统一接受的临床、神经影像学或实验室结局指标 手该核心为评价CNS功能的新结局指标提供了必要的支持，包括 神经认知评估（例如，筛选测试）和基于性能的功能 评估。此外，核心将为发展项目提供良好的个人， 作为新的神经影像学结局，可能对CNS功能障碍和治疗反应更敏感 而不是神经心理学测试临床核心还将提供特征良好的个人， 评估生物标志物核心中鉴定的新型实验室标志物。具体来说，我们将检查 细胞应激、神经元损伤和能量代谢，这些也被用作治疗的平台。 我们治疗核心的目标本核心的目标和目的如下：1）保持临床 充分表征的HIV+和人口统计学匹配的HIV-个体队列，以提高 积累和进行临床试验，2）与其他NIMH中心，其他资助的IPCP，艾滋病 临床试验组（ACTG），约翰霍普金斯大学艾滋病研究中心（JHU CFAR）， 临床和转化研究（ICTR）和约翰霍普金斯大学（JHU）药物发现部门， 协助开发HAND的介入治疗，3）提供基础设施和资源 有必要进行小型早期研究，以评估HAND的治疗方法，包括新药， 4）维护数据基础设施，以允许有效查询 临床和实验室数据，5）为所有涉及中心资助资源的研究提供统计支持。