The Four-Repeat Tauopathy Neuroimaging Initiative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 8
- 主要终点
- Eye Movement Function
研究概览
简要总结
The goal of this study is to identify the most reliable methods of analysis for tracking CBD, PSP, and o/vPSP over time. The results from this study may be used in the future to calculate statistical power for clinical drug trials. The study will also provide information about the relative value of novel imaging techniques for diagnosis, as well as the value of imaging techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No known history of neurological disease, or meet criteria for one of the following: Corticobasal Syndrome or Degeneration (CBS or CBD); Progressive Supranuclear Palsy (PSP); or Oligo- or Variant- Progressive Supranuclear Palsy (o/vPSP)
- •Needs a reliable study partner who has frequent contact with the participant, who is available to provide information about the participant, and who can accompany the participant to research visits as needed
- •Must be willing and able to undergo testing procedures, which include longitudinal follow-up visits
- •Must be able to walk five steps with minimal assistance
排除标准
- •Significant neurological disease other than CBD, PSP, or a variant PSP syndrome.
- •Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal fragments or metal objects in the eyes, skin, or body
- •In the site investigator's opinion, inability to complete sufficient key study procedures, or some other equivalent assessment of impairment
结局指标
主要结局
Eye Movement Function
时间窗: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of eye movement function.
Retinal Imaging
时间窗: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of retinal thickness.
Tau-PET Brain Scan
时间窗: Baseline, 1-year, and 2-years.
Change from Baseline of Tau protein distribution in the brain.
Brain Volume on MRI
时间窗: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of brain tissue volume.
UDS Neuropsychological Testing Battery, including supplemental FTLD Module
时间窗: Baseline, 6-months, 1-year, and 2-years.
Change fromm Baseline of cognitive function.
Amyloid-PET Brain Scan
时间窗: Baseline
Presence of Amyloid in the brain at Baseline.
Progressive Supranuclear Palsy Rating Scale (PSPRS)
时间窗: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of this rating scale.
Corticobasal Degeneration Functional Scale (CBDFS)
时间窗: Baseline, 6-months, 1-year, and 2-years.
Change from Baseline of this rating scale.
次要结局
未报告次要终点