18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 5
- 主要终点
- Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
研究概览
简要总结
This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitively Healthy Volunteers
- •Mini-mental state examination (MMSE) ≥ 28
- •No history of cognitive decline or parkinsonian motor disorder
- •CBD and PSP subjects
- •Able to walk 10 steps with minimal assistance
- •MMSE ≥ 14 and ≤ 30
- •Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject
- •PSP subjects only
- •Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial
- •CBD subjects only
- •Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype
排除标准
- •All subjects
- •Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI
- •Claustrophobia
- •Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval >450 msec)
- •Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
- •Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- •Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- •Have received or participated in a trial with investigational medications in the past 30 days
- •Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
- •Have a history of neuroleptic use for a prolonged period of time or within the past 6 months
- •PSP and CBD subjects
- •Have evidence of amyloid deposition
- •Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease
- •Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits
- •Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay
- •Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43 pathology or known mutations
研究组 & 干预措施
PSP Subjects
Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
干预措施: Flortaucipir F18 (Drug)
PSP Subjects
Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.
干预措施: Brain PET scan (Procedure)
CBD subjects
Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
干预措施: Flortaucipir F18 (Drug)
CBD subjects
Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.
干预措施: Brain PET scan (Procedure)
Healthy volunteers
Healthy volunteers receiving a flortaucipir PET scan at baseline.
干预措施: Flortaucipir F18 (Drug)
Healthy volunteers
Healthy volunteers receiving a flortaucipir PET scan at baseline.
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Flortaucipir Imaging in PSP, CBD and Healthy Volunteers
时间窗: baseline and 9 month scans
A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. 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