A Clinico-Pathological Study of the Correspondence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 31
- 主要终点
- Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score)
研究概览
简要总结
This study is designed to test the relationship between ante-mortem flortaucipir Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a projected life expectancy of ≤ 6 months
- •Can tolerate a 20 minute PET scan
- •Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die
排除标准
- •Aggressively being treated with life sustaining measures
- •Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
- •Clinically significant infectious disease
- •Currently receiving any investigational medications except with permission from the study sponsor
- •Participated in an experimental study with an amyloid or tau targeting agent
- •Suspected encephalopathy due to alcoholism or end-stage liver disease
- •Females of childbearing potential
- •History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
研究组 & 干预措施
Flortaucipir PET Scan
干预措施: Flortaucipir F18 (Drug)
Flortaucipir PET Scan
干预措施: PET Scan (Procedure)
结局指标
主要结局
Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score)
时间窗: at autopsy within 9 months of baseline scan
Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem flortaucipir PET imaging for detection of a pattern of flortaucipir neocortical uptake that corresponds to neurofibrillary tangles (NFT) Score of B3 (Hyman et al., 2012; Montine et al., 2012). NFT B scores range from B0 (Braak Stage 0; no NFTs in the brain) to B3 (Braak Stage V/VI; widespread NFTs in the brain). Sensitivity and specificity are percentages that can range from 0 to 100%. The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs ≥50%, for both sensitivity and specificity.
Primary Outcome 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
时间窗: at autopsy within 9 months of baseline scan
Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem flortaucipir imaging for detection of a pattern of flortaucipir neocortical uptake that corresponds to high levels of Alzheimer's disease neuropathologic change (High ADNC) as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. ADNC categories are None, Low, Intermediate and High, with High indicating the most severe level of AD-related pathology changes in the brain (Hyman et al., Alzheimers Dement. 2012 Jan;8(1):1-13). The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% CIs ≥50%, for both sensitivity and specificity.
次要结局
- Flortaucipir Diagnostic Performance (NFT Score)(at autopsy within 9 months of baseline scan)
- Flortaucipir Diagnostic Performance (NIA-AA Autopsy Diagnosis)(at autopsy within 9 months of baseline scan)
- Inter-Reader Agreement(baseline scan)