A Non-therapeutic Feasibility Study to Evaluate the Kinetics and Test-retest Repeatability and Reproducibility of the Radioligand [11C]-UCB-J for Imaging Synaptic Density in Healthy Subjects and Mild-to-moderate Alzheimer's Disease Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Measure concentration of radioactivity as a function of time according to pre-defined brain regions
研究概览
简要总结
Up to 20 subjects will receive an injection with [11C]-UCB-J followed by a PET scan on Days 1 and 28
详细描述
After assessing eligibility during a 4-week screening period, approximately 20 subjects will participate in the PET acquisition phase of the study. Drop-outs or unevaluable subjects will be replaced for a target sample size of 20 completed and evaluable subjects.
During the screening period, a 3D T1-weighted MRI must be acquired and reviewed for exclusion criteria and acquisition quality.
On the day of radioligand administration (Day 1), subjects will come to the study center for an ambulatory visit (Visit 1). After re-confirming eligibility, all subjects will receive an injection with [11C]-UCB-J followed by a PET scan.
Using an arterial line and manual sampling, blood samples will be collected up to 90 minutes after radioligand injection in order to quantify radioactivity concentration in whole blood and plasma as well as parent fraction over time.
Subjects will return to the clinic for one more ambulatory visit on Day 28 ± 3 (Visit 2). The same procedures will be performed as on Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female age 55 - 75 years old, inclusive, at the time of informed consent.
- •Mini-mental state examination (MMSE) greater than or equal to
- •Adult males or females age 55 - 75 years old, inclusive, at the time of informed consent.
- •Confirmed diagnosis of mild-to-moderate AD, defined as:
- •National Institute on Aging - Alzheimer's Association (NIA-AA) "probable" diagnosis (see Appendix 2);
- •MMSE 18-26.
排除标准
- •History or current evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD in Group 2), psychiatric, renal, or other major disease, as determined by the Investigator.
研究组 & 干预措施
Healthy subjects [11C]-UCB-J
Net dose of approximately 370 megabecquerel (MBq) of [11C]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
干预措施: [11C]-UCB-J (Other)
AD patients [11C]-UCB-J
Net dose of approximately 370 megabecquerel (MBq) of [11C]-UCB-J, Total injected mass of UCB-J per will not to exceed 10 µg for each dose given on Days 1 and 28
干预措施: [11C]-UCB-J (Other)
结局指标
主要结局
Measure concentration of radioactivity as a function of time according to pre-defined brain regions
时间窗: Day 1 to 28
Measure [11C]-UCB-J plasma radioactivity levels in plasma over time
时间窗: Day 1 to 28
次要结局
未报告次要终点