18F-AV-1451 PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 主要终点
- Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
研究概览
简要总结
A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the preclinical, prodromal and dementia phases of Alzheimer's disease.
详细描述
The Australian Imaging Biomarkers and Lifestyle Study (AIBL) is a multicenter multidisciplinary study of Alzheimer's disease and aging funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Flagship Initiative, involving research centers in both Victoria and Western Australia. The goal of the A08 protocol was to further investigate the positron emission tomography (PET) imaging results with flortaucipir in patients across the AD spectrum from individuals with subjective memory complaints (SMC) to those with dementia, based on recruitment into the parent AIBL study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or planned and MRI available
- •Subjects in the MCI and AD groups required to have a reliable caregiver capable of providing information about the subjects' symptoms
排除标准
- •lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
- •history of electroconvulsive therapy
- •MRI contraindicated
- •claustrophobic or, otherwise, unable to tolerate the imaging procedure
- •current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
- •history of additional risk factors for Torsades de Pointes
- •current clinically significant infectious disease, endocrine or metabolic disease, or pulmonary, renal, or hepatic impairment that the investigator believes would affect study participation
- •history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
- •current drug or alcohol abuse/dependence
- •history of alcohol abuse/dependence with 2 years of the onset of the symptoms of dementia
- •females of childbearing potential who were not surgically sterile, not refraining from sexual activity, or not using reliable methods of contraception
研究组 & 干预措施
Alzheimer's disease (AD)
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Flortaucipir F18 (Drug)
Alzheimer's disease (AD)
Alzheimer's disease subjects receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Brain PET scan (Procedure)
Mild cognitive impairment (MCI)
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Flortaucipir F18 (Drug)
Mild cognitive impairment (MCI)
Mild cognitive impairment subjects receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Brain PET scan (Procedure)
Subjective memory complainers (SMC)
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Flortaucipir F18 (Drug)
Subjective memory complainers (SMC)
Subjective memory complainers receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Brain PET scan (Procedure)
Cognitively normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Flortaucipir F18 (Drug)
Cognitively normal (CN)
Cognitively normal subjects receiving a flortaucipir PET scan at baseline and 12 months
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Number of Participants With AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
时间窗: baseline scan
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with AD Pattern scans (Advanced \[τAD++\] and Moderate \[τAD+\] Scan Pattern) were combined vs. the Not AD pattern group (τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B (\[C-11\] PiB) PET results available from the parent AIBL study.
Number of Participants With Advanced AD Pattern Flortaucipir PET Scan and Relationship to Cognitive Status
时间窗: baseline scan
Scans were visually read independently by two expert readers at the sponsor, blinded to any clinical information. Subject scans were categorized as follows: Advanced AD Scan Pattern (τAD++), Moderate AD Scan Pattern (τAD+), Not AD Scan Pattern (τAD-). For this analysis, subjects with Advanced (τAD++) scans were analyzed vs. the combined Moderate and Not AD pattern groups (τAD+/τAD-). Amyloid status was obtained by florbetapir or carbon-11-labeled Pittsburgh compound B (\[C-11\] PiB) PET results available from the parent AIBL study.
Flortaucipir PET Imaging (Quantitative)
时间窗: baseline scan
Flortaucipir PET cortical weighted average standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
次要结局
未报告次要终点