NCT06289582招募中1 期
Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.
研究概览
简要总结
The overall goal of this protocol is to investigate [18F]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in [18F]DPA-714 binding in PD participants during a 24-month interval.
Primary Objectives
- To compare [18F]DPA-714 binding in prodromal and manifest PD and healthy volunteers.
- To determine the longitudinal change in [18F]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.
Secondary Objectives
- To evaluate the correlation between baseline [18F]DPA-714 and PPMI clinical and biomarker outcomes.
- To evaluate the correlation between the longitudinal change of [18F]DPA-714 and PPMI clinical and biomarker outcomes
- To acquire safety data following injection of [18F]DPA-714
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol
- •A PD participant enrolled in PPMI Clinical protocol who has not started symptomatic treatment at time of enrollment or in the first 2 years of participation.
- •Able to provide informed consent
- •Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)
- •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]DPA-714
- •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.
- •Includes a negative urine pregnancy test prior to injection of [18F]DPA-714 on day of PET scan.
排除标准
- •Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations , 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
Prodromal and manifest (PD) participants
Experimental
干预措施: [F-18]DPA714 administration IV (Drug)
Healthy participants
Experimental
干预措施: [F-18]DPA714 administration IV (Drug)
结局指标
主要结局
Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.
时间窗: 24 months
The changes over time in neuroinflammation based on TSPO will be assessed by comparing TSPO-PET imaging at baseline, 12 months and 24 months after enrollment.
次要结局
未报告次要终点
研究者
Deepak Prabataram Kalbi
Assistant Professor
University of Alabama at Birmingham
研究点 (2)
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