Imaging Biomarkers in Preclinical and Symptomatic AD. (ACS PiB IND)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD
研究概览
简要总结
The purpose of this research study is to evaluate adult children of parents with and without Alzheimer's disease which represent an ideal population for investigating the biological changes that precede the clinical onset of AD. The investigators will be imaging the brain to detect the presence of amyloid deposits (plaques in the brain). Amyloid is a protein that may be related to dementia of Alzheimer's disease (DAT).
详细描述
This study will use a radioactive tracer called [11C]-Pittsburgh Compound B (11C]PIB), which is a tracer that binds to beta amyloid protein in the brain. This compound is considered investigational, which means that it has not been approved by the United States Food and Drug Administration (FDA).
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;
- •Active participants currently enrolled in the Knight Alzheimer's Disease Research Center (ADRC) at Washington University.
排除标准
- •Hypersensitivity to [11C] PIB or any of its excipients;
- •Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate;
- •Severe claustrophobia;
- •Women who are pregnant or breast-feeding will be excluded from PIB PET participation;
- •Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data;
- •Currently participating in any clinical trial which involves an active study medication or placebo within the past 30 days before scanning and up to 2-weeks past the imaging visit.
- •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
[11C] Pittsburgh Compound-B (PIB)
Using [11C] Pittsburgh Compound-B (PIB) to look for biomarkers in preclinical and symptomatic AD.
干预措施: [11C] Pittsburgh Compound-B (PIB) (Drug)
结局指标
主要结局
develop an integrated timeline for the imaging changes which occur during the transition from asymptomatic to symptomatic AD
时间窗: 5 years
the annual rate of CDR progression will accelerate due to the aging of the ACS cohort., and estimate that among \~375 ACS participants who either remain CDR 0 currently and will continue to be clinically assessed or will be the new future enrollees, a total of 45 individuals will progress to CDR\>0 by the end of next funding cycle.
次要结局
未报告次要终点
研究者
Tammie L. S. Benzinger, MD, PhD
Professor of Radiology, Neuroradiology Section Professor of Neurological Surgery Director, Knight Alzheimer Research Imaging Program
Washington University School of Medicine