Investigation of Inflammation in Alzheimer's Disease and Related Dementias (ADRD) Using [11C]-CS1P1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer.
研究概览
简要总结
This study involves a brain positron emission tomography (PET) scan with a new, investigational radioactive tracer called [11C]-CS1P1 to identify inflammation in the brain by testing with healthy older adults and with cognitively impaired older adults.
详细描述
The primary objective of this IND study is to further evaluate the [11C]-CS1P1 for PET imaging of S1P1 expression in healthy older adults and in adults with Alzheimer's disease and Related Dementia (ADRD). Investigators will complete imaging of the brain and neck in older adults with normal cognition and those with clinically diagnosed cognitive impairment from ADRD to characterize [11C]-CS1P1 uptake in the brain. Investigators will compare the normal cognition participants to patients with ADRD to collect preliminary data that will subsequently test the hypothesis that [11C]-CS1P1 uptake is elevated in patients with ADRD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, any race;
- •Age ≥ 50 years;
- •Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure;
- •Additional inclusion for ADRD group: clinical diagnosis of mild cognitive impairment or early dementia due to ADRD, OR biomarker diagnosis of Alzheimer's disease, with or without symptoms.
排除标准
- •Hypersensitivity to [11C]-CS1P1 or any of its excipients;
- •Contraindications to PET, CT, or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate;
- •Severe claustrophobia;
- •Women who are currently pregnant or breast-feeding;
- •Currently undergoing radiation therapy;
- •Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, advanced cancer);
- •Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including high grade heart block (type 2 or greater), unstable angina, or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
- •Moderate to Severe anemia with Hemoglobin < than 9.9 in both males and females.
- •Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.
- •https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
研究组 & 干预措施
Healthy participants
Healthy participants will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a brain [11C]-CS1P1 PET scan
干预措施: [11C]-CS1P1 (Drug)
Participants with cognitive impairment (Alzheimer's disease)
Participants with cognitive impairment will receive a single intravenous bolus injection of 12.0 - 17.0 milliCurie (mCi) of the investigational radiotracer [11C]-CS1P1. Participants will then undergo a brain [11C]-CS1P1 PET scan
干预措施: [11C]-CS1P1 (Drug)
结局指标
主要结局
PET imaging studies of [11C]-CS1P1 in healthy control participants and participants with Alzheimer's Disease and measuring the uptake of [11C]-CS1P1 tracer.
时间窗: Through study completion, an average of 1 year
To test the hypothesis that specific binding of \[11C\]-CS1P1 is elevated in participants with ADRD compared to healthy normal control participants.
次要结局
未报告次要终点
研究者
Tammie L. S. Benzinger, MD, PhD
Professor of Radiology Division, Diagnostic Radiology Section, Neuroradiology
Washington University School of Medicine