F 18 T807 Tau PET Imaging of Alzheimer's Disease [IND# 123119] Protocol A
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
研究概览
简要总结
A single-center, open-label baseline controlled imaging study designed to assess whether brain tau fibril uptake of flortaucipir as measured by PET correlates with cognitive status of individuals with and without brain tau fibrils.
详细描述
This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with and without brain tau fibrils. The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.
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
- 否
入选标准
- •Male or female participants, at least 18 years of age.
- •Cognitively normal, or with mild dementia, as assessed clinically
- •Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
- •Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration.
排除标准
- •Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- •Is deemed likely unable to perform the imaging procedures for any reason.
- •Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
- •Has hypersensitivity to F 18 T807 or any of its excipients.
- •Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- •Severe claustrophobia.
- •Currently pregnant or breast-feeding.
- •For those electing to undergo the optional lumbar puncture: currently on anticoagulant of any form -
研究组 & 干预措施
Experimental F 18 T807
Participants will undergo a PET scan using the flortaucipir imaging tracer
干预措施: F 18 T807 (Drug)
结局指标
主要结局
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
时间窗: 5 years
Employing statistical parametric mapping (SPM), a voxel-based analytic measure in order to quantify and co-localize the imaging patterns from the multiple imaging datasets in this study.
次要结局
未报告次要终点
研究者
Tammie L. S. Benzinger, MD, PhD
Professor of Radiology & Neurological Surgery
Washington University School of Medicine