18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Quantitative Evaluation of Flortaucipir PET Scans
研究概览
简要总结
This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
- •Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
- •Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
- •Can tolerate PET scan procedures
排除标准
- •Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
- •Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
- •Have history of drug or alcohol dependence within the last year
- •Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
- •Have history of relevant severe drug allergy or hypersensitivity
- •Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session
- •Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
- •Possess PET scan evidence of amyloid deposition
- •Determined by the investigator to be unsuitable for this type of study
研究组 & 干预措施
FTD Subjects
Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan
干预措施: Flortaucipir F18 (Drug)
FTD Subjects
Subjects diagnosed by dementia specialist with a clinical Frontotemporal Dementia (FTD) syndrome and expected tau or tar DNA binding protein (TDP)-43 pathology receiving a flortaucipir PET scan
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Quantitative Evaluation of Flortaucipir PET Scans
时间窗: baseline scan
Standard Uptake Value Ratio (SUVr) using a weighted cortical average (MUBADA), and individual regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Qualitative Evaluation of Flortaucipir PET Scans
时间窗: baseline scan
Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's Disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.
次要结局
未报告次要终点