NCT01834625终止不适用
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
In this pilot study the investigators shall prospectively in a blinded fashion evaluate with Aβ PET in patients committed to shunt surgery and then investigate the relationship of these biomarkers with outcome on gait, cognition and urinary control improvement in the short term (3 months) and long term (1 year). The imaging agent will be provided by AVID.
Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual and auditory acuity adequate for neuropsychological testing.
- •Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
- •Must speak English fluently.
- •Willing to undergo one Amyloid imaging PET scan.
- •Agrees to at least one lumbar puncture for the collection of CSF.
- •Must agree to return for a Month 3 and Month 12 visit.
- •Participant, who in the opinion of the investigator, can tolerate the PET scan procedures
排除标准
- •History of schizophrenia (DSM IV criteria).
- •History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- •Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
- •Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.
- •Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the participant?
- •Current clinically significant cardiovascular disease, including one or more of:
- •cardiac surgery or myocardial infarction within the last 4 weeks;
- •unstable angina;
- •acute decompensated congestive heart failure or class IV heart failure
结局指标
主要结局
Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline to 1 year
次要结局
未报告次要终点
研究者
Neill R. Graff-Radford, M.D.
Professor of Neurology
Mayo Clinic
研究点 (1)
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