Imaging of Brain Structural/Functional Connectivity and Amyloid and Tau Lesions in APOE4 Carriers. (IND 123119, Protocol Z)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- F 18 T807 Standard Uptake Value Ratios
研究概览
简要总结
To advance current knowledge on the vascular contributions to dementia
详细描述
This is a multi-center study at Washington University (WASH U), University of Southern California (USC), and Huntington Medical Research Institute (HMRI).The overall goal of both the AA program and the PPG program is to advance current knowledge on the vascular contributions to dementia particularly in individuals with the major genetic risk factor for late-onset AD, i.e., apolipoprotein E-ε4 (APOE4) gene that develop early vascular dysfunction and significant cerebrovascular pathology compared to non-carriers, and establish whether the neurovasculature plays a key role in cognitive decline, and therefore is a key new therapeutic target to treat dementia in APOE4 carriers.
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, any race
- •Age > 18 years
- •Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
- •Normal cognition or early-stage symptomatic AD
- •Females of childbearing potential without documented history of menopause or hysterectomy who do participate must not be pregnant or breastfeeding at screening
- •(negative urine β-HCG within 24 hours prior to injection), and must agree to avoid becoming pregnant. Females of childbearing potential who do not agree to use reliable contraception or refrain from sexual activity for 24 hours following administration of flortaucipir injection.
- •Enrollment in DCE-MRI study
- •Capacity to give informed consent and follow study procedures
排除标准
- •Any illness preventing cooperation with testing or longitudinal participation
- •Exclusion from the Knight ADRC or DIAN referring project
- •Has a high risk for Torsades de Pointes or is taking medications known to prolong or may prolong QT interval (refer to study attachment "Restricted Medication List").
- •MRI contraindications (e.g. electronic medical devices, severe claustrophobia, inability to lie still for long periods) that make it unsafe to participate in an MRI scan, using standard screening processes implemented by Washington University and Barnes-Jewish Hospital
- •Currently pregnant or breastfeeding
研究组 & 干预措施
Experimental Flortaucipir
Participants will receive a single intravenous bolus injection of flortaucipir along with PET imaging.
干预措施: F 18 T807 Flortaucipir (Drug)
结局指标
主要结局
F 18 T807 Standard Uptake Value Ratios
时间窗: 5 years
F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.
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