NCT07177352招募中3 期
Master Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies as Assessed by Biomarker Status and Cognition
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80,000
- 试验地点
- 229
- 主要终点
- Concentration of pTau217 in Blood on Day1
研究概览
简要总结
This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to participate in an interventional clinical study, including meeting key eligibility criteria of linked interventional Roche AD studies (e.g., specific age ranges)
- •Ability and willingness to receive information about potential eligibility in an associated interventional Roche AD study
排除标准
- •Dependency in basic activities of daily living (bADLs) due to cognitive impairment
- •Visual or auditory impairment that would prevent them from performing the cognitive assessments (eyeglasses and hearing aids are permitted)
- •Any self-reported evidence or known diagnosis of a neurological or neurodegenerative condition that may lead to cognitive impairment other than AD
- •History of severe, clinically significant central nervous system trauma
- •Any serious medical condition that precludes a participant's safe participation and completion of a clinical study
- •For participants with a clinical diagnosis of MCI or mild AD: Previous AD diagnosis based on biomarker confirmation with an approved or validated rule in method (e.g., amyloid PET or cerebrospinal fluid, blood biomarker) is exclusionary
研究组 & 干预措施
Screening Arm
Other
Participants will be assessed for their concentration of pTau217 in blood and cognitive score in the International Shopping List Test (ISLT).
干预措施: No Intervention (Other)
结局指标
主要结局
Concentration of pTau217 in Blood on Day1
时间窗: Day 1
Cognitive score in ISLT on Day 1
时间窗: Day 1
Concentration of pTau217 in Blood on Day1
时间窗: Day 1
Cognitive score in ISLT on Day 1
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (229)
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