Assessment of Brain Tau Burden in Participants With Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Determination of [18F]PI-2620 standard uptake value ratio (SUVR) targeting brain tau deposition in comparison between Parkinson disease and healthy control participants.
研究概览
简要总结
The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) will evaluate if [18F] PI-2620 facilitates better understanding of Tau deposition in the brain in Parkinson's disease (PD).
详细描述
The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) is a companion study to the Parkinson's Progression Markers Initiative Clinical protocol (PPMI-002; NCT04477785). After consenting to the PPMI Clinical protocol, participants interested in completing an additional scan under this study will be asked to complete consent, additional activities, and one [18F]PI-2620 PET imaging scan as part of this study. Enrollment in the PPMI Tau PET Imaging companion study will facilitate comparison of tau deposition to clinical, imaging, blood and CSF tau already acquired in these PPMI participants under the PPMI Clinical protocol. The primary goal of this imaging study is to test whether positron emission tomography (PET) with [18F] PI-2620 can visualize in vivo brain tau deposition in participants with PD. The secondary goal is to evaluate tau deposition in PD LRRK2 mutation carriers given recent data that tau pathology may be present in those individuals.
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
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in PPMI Clinical protocol
- •Able to provide informed consent
- •Male or Female (Females must meet additional criteria specified below, as applicable)
- •Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of [18F]PI-
- •Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- •Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
- •Females of childbearing potential must not be pregnant, breastfeeding or lactating.
- •Females of childbearing potential have a negative urine pregnancy test prior to [18F]PI-2620 injection on day of PET scan.
排除标准
- •Exposure to an effective radiation dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines during the past year.
- •Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.
研究组 & 干预措施
Study Drug
All participants will receive PI-2620.
干预措施: [18F] PI-2620 (Drug)
结局指标
主要结局
Determination of [18F]PI-2620 standard uptake value ratio (SUVR) targeting brain tau deposition in comparison between Parkinson disease and healthy control participants.
时间窗: 90 minutes
次要结局
未报告次要终点