Clinical Core

临床核心

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要 - 临床核心在晚期感染的 HIV+ 个体中，HAND 的患病率仍保持在 40-50% 左右，并且 HAND 可能目前已成为全球最常见的青少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、神经影像或实验室结果测量手。该核心提供评估中枢神经系统功能新结果测量所需的支持，包括神经认知评估（例如，HAND 筛选测试）和基于表现的功能评估。此外，核心将为发展项目提供具有良好特征的个人，例如作为新的神经影像结果，可能对中枢神经系统功能障碍和治疗反应更敏感比神经心理学测试措施。临床核心还将为以下领域提供具有良好特征的个人：评估生物标记核心中确定的新型实验室标记。具体来说，我们将检查以下标记细胞应激、神经元损伤和能量代谢，这些也被用作治疗平台我们的治疗核心目标。该核心的目的和目标如下： 1) 维持临床由特征明确的 HIV+ 和人口统计匹配的 HIV- 个体组成的队列，以提高治疗效率积累和开展临床试验，2) 与其他 NIMH 中心、其他受资助的 IPCP、艾滋病中心联络临床试验组 (ACTG)、约翰霍普金斯大学艾滋病研究中心 (JHU CFAR)、研究所临床和转化研究 (ICTR) 以及约翰霍普金斯大学 (JHU) 药物发现部门协助开发HAND介入疗法，3）提供基础设施和资源有必要进行小型早期研究来评估 HAND 的治疗方法，包括新药，神经调节和行为策略，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) 为涉及中心拨款资源的所有研究提供统计支持。