Clinical Core

项目摘要-临床核心 Hand在HIV+晚期感染者中的患病率保持在40%-50%左右，Hand可能 现在是全球最常见的青少年神经认知障碍形式。目前没有 用于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。该核心提供必要的支持，以评估CNS功能的新结果衡量标准，包括 神经认知评估(例如，手的筛查测试)和基于表现的功能 评估。此外，核心将为发展项目提供性格良好的个人，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 而不是神经心理测试手段。临床核心还将为以下人员提供良好的个性 评估在Biomarker Core中确定的新的实验室标记。具体地说，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 我们治疗核心中的靶点。这个核心的目标和目的如下：1)保持临床 特征良好的HIV+和人口统计匹配的HIV-个人队列，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 临床试验小组(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(卢旺达问题国际法庭)和约翰霍普金斯大学(JHU)药物发现单位 协助手部介入治疗的发展，3)提供基础设施和资源 有必要进行小规模早期研究，以评估包括新药在内的手部疗法， 神经调节和行为策略，4)维护数据基础设施，以允许高效查询 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。

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.