NCT02605785招募中不适用
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 332
- 试验地点
- 2
- 主要终点
- The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
研究概览
简要总结
This study is designed to learn more about overall tau burden in the brain of patients with Progressive Supranuclear Palsy (PSP).
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be over 35 years of age and present with gradual progression of PSP-related symtoms
- •Must have an informant or study partner that can provide independent information of functioning.
- •Must meet criteria for possible or probable Progressive Supranuclear Palsy. To fulfill criteria for possible PSP, subjects must have a gradually progressive disorder with either vertical (upward or downward) supranuclear palsy or both slowing of vertical saccades and prominent postural instability with falls in the first year of disease onset. To fulfill criteria for probable PSP, subjects must have vertical (upward or downward gaze) supranuclear palsy and prominent postural instability with falls in the first year of disease onset.
排除标准
- •Subjects will be excluded if they meet criteria for another neurodegenerative disease (including corticobasal syndrome, frontotemporal dementia, primary progressive aphasia, Alzheimer's disease, multiple system atrophy and Parkinson's disease) or do not have the symptoms necessary to fulfill inclusion criteria for possible PSP.
- •Subjects with concurrent illnesses that could account for their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes will be excluded.
- •Women that are pregnant or post-partum and breast-feeding will be excluded.
- •Subjects will be excluded from the study if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome.
- •Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g. chemotherapy).
- •Subjects will also be excluded if they do not have an informant, or do not consent to research.
研究组 & 干预措施
Tau PET Scan, F-18 AV 1451
Experimental
All subjects will received a Tau PET scan.
干预措施: F-18 AV 1451 (Drug)
结局指标
主要结局
The investigators will be looking at the amount of Tau protein in the brain of patients with PSP.
时间窗: 5 years
次要结局
- Rates of change in tau-PET burden over time.(baseline, 1 year)
研究者
Keith A. Josephs
Professor of Neurology
Mayo Clinic
研究点 (2)
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