An Open Label, Single Center Study to Evaluate the Safety and Test-retest Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau Deposition in the Brains of Patients With Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS) Compared to Non-demented Controls (NDC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
The overall goal of this protocol is to evaluate the imaging characteristics of [18F]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS)
详细描述
The imaging characteristics of [18F]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS) will be evaluated by a) determining the test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls (NDC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients
All eligible PSP patients will receive two injections of the investigational imaging agent [18F]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 10 PSP patients will be required to complete the study arm.
干预措施: [18F]-PI2620 (Drug)
Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects
All eligible non-demented control (NDC) subjects will receive two injections of the investigational imaging agent [18F]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 NDC subjects will be required to complete the study arm.
干预措施: [18F]-PI2620 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: The duration of the study for participants may be up to 74 days
Safety will be evaluated by collection of Adverse Events.
Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls
时间窗: The duration of the study for participants may be up to 74 days
Test-retest variability of \[18F\]PI-2620 accumulation will be analyzed using quantification
次要结局
- Correlate radioligand binding in PSP-RS with clinical scales(The duration of the study for participants may be up to 74 days)
- Compare quantification in terms if test-retest variability in PSP-RS and NDC(The duration of the study for participants may be up to 74 days)