An Open-Label, Non-Randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection of Cerebral ß-Amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 主要终点
- Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome
研究概览
简要总结
To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participants were individuals with DS and healthy volunteers (HVs).
- •Main inclusion criteria for individuals without DS
- •>=21 and <= 40 years of age
- •Mini-Mental State Examination (MMSE) >= 28
- •Clinical Dementia Rating (CDR) of 0
- •Main inclusion criteria for individuals with DS
- •>= 40 years of age
排除标准
- •Main exclusion criteria for both groups
- •Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time
研究组 & 干预措施
Florbetaben (BAY94-9172)
干预措施: Florbetaben (BAY94-9172) (Drug)
结局指标
主要结局
Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome
时间窗: 100-120 min
The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.
次要结局
- Sensitivity Results in the Down Syndrome Age Subgroups(100 - 120 min)
- Quantitative Parameters Standard Uptake Value Ratio(100 - 120 min p.i.)
- Consistency Between Visual and Quantitative Efficacy(100 - 120 min)