M1 精神分裂症 PET 研究
2024年3月21日 更新者：Rajiv Radhakrishnan, MD、Yale University
精神分裂症中毒蕈碱 M1 受体的可用性和认知
这项探索性研究旨在检查 SZ 患者的 M1 受体可用性，并将 M1 受体可用性与认知表现的近端和远端测量相关联，即脑电图和语言记忆中诱发的 ɣ 振荡。
此外，还将探讨海马 [11C]EMO 可用性 (BPND)、诱发的 ɣ 振荡、语言记忆和疾病严重程度测量之间的关系。
研究概览
详细说明
来自死后研究的汇聚证据提供了强有力的证据，证明精神分裂症 (SZ) 患者的一个子集存在脑毒蕈碱 M1 受体缺陷。 M1 受体是 SZ 中认知缺陷的重要目标。 然而，直到现在，还无法检查 SZ 在体内 M1 受体可用性方面的异质性。 耶鲁 PET 中心开发的新型正电子发射断层扫描 (PET) 配体 [11C]EMO 提供了一个独特的机会，可以首次检查 SZ 中体内脑毒蕈碱 M1 受体的可用性，同时阐明两者之间的关系M1 受体对 SZ 认知缺陷的影响。
研究人员将使用 [11C]EMO 和高分辨率研究断层扫描仪 (HRRT) 比较 SZ 患者和年龄、性别匹配的健康对照者的 M1 受体可用性，HRRT 是一种具有高灵敏度和高分辨率的 PET 扫描仪，可用于人脑成像。 本研究将探索以下之间的关系：海马 [11C]EMO 结合（作为海马 M1 AChR 可用性的衡量标准）、语言记忆任务期间编码相关的 γ 功率、语言记忆、性别和血清乙酰胆碱水平。 这项探索性研究将提供必要的试点数据，以进行更大规模的研究，以充分调查 SZ 在 M1 受体可用性方面的异质性。
研究类型
介入性
注册 (实际的)
18
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rajiv Radhakrishnan, MD
- 电话号码：4080 203-932-5711
- 邮箱：rajiv.radhakrishnan@yale.edu
研究联系人备份
- 姓名：Deepak D'Souza, MD
- 电话号码：2594 203-932-5711
- 邮箱：deepak.dsouza@yale.edu
学习地点
-
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Connecticut
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New Haven、Connecticut、美国、06519
- Connecticut Mental Health Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人、年长者)
接受健康志愿者
是的
描述
纳入标准：
- 除 DSM-5 精神分裂症或分裂情感障碍诊断外，身心健康的 18-55 岁男性和女性
- 体内没有金属的受试者可能在 MRI 扫描期间构成风险
- 没有明显的病史，包括头部外伤和出血性疾病
排除标准：
- 有临床显着疾病病史或存在的男性和女性
- 无法戒烟 5 天的吸烟者
- 患有幽闭恐惧症、有不兼容 MRI 植入物或其他 MRI 和 PET 扫描禁忌症的人
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：11C-EMO - 一种用于毒蕈碱 M1 受体的新型 PET 放射性示踪剂
参加者将进行一次 [11C]EMO ≤ 20 mCi 的 PET 扫描
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放射性示踪剂 [11C]EMO 将在每次 PET 扫描开始时使用。
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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海马 M1 可用性
大体时间：10天
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通过 [11C]EMO 可用性 (BPND) 衡量
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10天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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诱发 ɣ 振荡
大体时间：10天
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通过脑电图测量
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10天
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口头记忆
大体时间：10天
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通过认知评估衡量
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10天
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rajiv Radhakrishnan, MD、Yale University
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年4月20日
初级完成 (实际的)
2023年10月31日
研究完成 (实际的)
2023年10月31日
研究注册日期
首次提交
2021年10月22日
首先提交符合 QC 标准的
2021年10月22日
首次发布 (实际的)
2021年11月3日
研究记录更新
最后更新发布 (实际的)
2024年3月22日
上次提交的符合 QC 标准的更新
2024年3月21日
最后验证
2024年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 2000031171
- 1R21MH123870-01A1 (美国 NIH 拨款/合同)
- 1R01MH113557-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.