跳至主要内容
临床试验/NCT01000870
NCT01000870终止早期 1 期

An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate Efficacy & Safety of MNI-513 Positron Emission Tomography for Detection/Exclusion of Cerebral Amyloid Beta in Patients w/ Alzheimer Disease Compared to Healthy Volunteers

Institute for Neurodegenerative Disorders1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
终止
入组人数
6
试验地点
1
主要终点
To evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers

研究概览

简要总结

The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers.

详细描述

To determine diagnostic efficacy of the MNI-513 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. PET scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The nuclear physician will be unaware of the clinical diagnosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Access MNI-513 and PET Imaging

Experimental

干预措施: MNI-513-01 (Drug)

结局指标

主要结局

To evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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