Fluselenamyl - Beta Amyloid PET Imaging for Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging.
研究概览
简要总结
The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.
The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.
Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging along with MRI will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.
Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed.
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
- 18 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 ≥ 18 years
- •Healthy volunteers or volunteers with Alzheimer's disease
排除标准
- •Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
- •Has hypersensitivity to 11C-PIB or any of its excipients ;
- •Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
- •Unwilling or unable to undergo PET scans tracer injections ;
- •Unwilling or unable to undergo MRI (Aim 2 and Aim 3);
- •Any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
- •Women who are currently pregnant or breast-feeding;
- •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 361.1.
研究组 & 干预措施
Healthy participants
Drug: [18F]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush.
Drug: [11C]-Pittsburgh Compound ([11C]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET certified professional will prepare and administer the [11C]-PIB tracer. Participants will receive the PIB injection followed by 10 ml 0.9% sodium chloride (normal saline) flush.
干预措施: 18F-Fluselenamyl (Drug)
Participants with mild cognitive impairment
Drug: [18F]-Fluselenamyl. A dosage range of 10 mCi +/- 20% of Fluselenamyl will be injected by a PET certified medical professional followed by 10 ml 0.9% sodium chloride (normal saline) flush.
Drug: [11C]-Pittsburgh Compound ([11C]PIB) A dosage range between 6.0-20.0 mCi is planned. A PET certified professional will prepare and administer the [11C]-PIB tracer. Participants will receive the PIB injection followed by 10 ml 0.9% sodium chloride (normal saline) flush.
干预措施: 18F-Fluselenamyl (Drug)
结局指标
主要结局
To determine the safety of the tracer [18F]-Fluselenamyl for PET Imaging.
时间窗: 1 year
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of \[18F\]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans). The primary objective is to evaluate the biodistribution, kinetics and calculate human dosimetry of this radioligand and confirm it's lack of toxicity in human subjects.
PET imaging of [18F]-Fluselenamyl in healthy normal control participants and human participants with mild cognitive impairment of Alzheimer's dementia.
时间窗: 2 years
To assess the sensitivity of \[18F\]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct comparative analysis of PET imaging data using \[11C\]-PIB imaging in same participants.
次要结局
未报告次要终点
研究者
Tammie L. S. Benzinger, MD, PhD
Professor of Radiology and Neurological Surgery
Washington University School of Medicine