Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fluctuations in plasma pTau217 biomarker results
研究概览
简要总结
This is an observational study that will serially collect 10 plasma samples over the course of 9 weeks from the same individuals to assess fluctuations in blood biomarker results.
详细描述
Blood biomarkers offer a less invasive and cheaper method for identifying Alzheimer's disease (AD)-related changes. Already, blood biomarkers for AD are being adopted by clinical practice and their use will only expand in coming years. However, blood biomarkers are susceptible to fluctuations not yet well characterized. Such fluctuations, although rarely observed in current research settings, may influence the biological evaluation of dementia once implemented into routine settings. The study at present aims to identify how blood biomarkers fluctuate over a short period of time in the same individual and assess drivers of these fluctuations.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able and wiling to provide informed consent
- •Aged 50-80 years old at the time of signing study consent; participants aged 50-59 years will be no more than 20% of the total study population
- •Has normal cognition or mild impairment at screening MoCA by a score of greater than or equal to 18; participants with a Montreal Cognitive Assessment (MoCA Test) score between 18-25 will be no more than 20% of the total study population
- •able and wiling to fully comply with study procedures defined in the protocol
- •Written and spoken fluency in English
排除标准
- •Plans to begin any new treatment or is having surgery during the 9-week draw timeframe
- •Currently enrolled in a clinical trial using an investigational drug
结局指标
主要结局
Fluctuations in plasma pTau217 biomarker results
时间窗: 9 weeks
Assess within participant changes in plasma pTau217 biomarker assay levels over the course of the study
Frequency of large unknown biomarkers spike
时间窗: 9 weeks
Determine the frequency of large, unknown biomarkers spike that would influence a clinical decision.
次要结局
未报告次要终点