Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 4
- 主要终点
- Blood biomarkers （pTau217、Aβ42、GFAP）
研究概览
简要总结
The goal of this prospective, multicenter, observational cohort study is to evaluate the screening performance of blood-based biomarkers for Alzheimer's disease (AD) in a real-world community screening setting, and to establish the population baseline levels and reference intervals of these biomarkers in Chinese older adults.
The main questions it aims to answer is:
What is the clinical screening value of blood biomarkers (phosphorylated tau 217 to amyloid β 42 ratio [pTau217/Aβ42] and glial fibrillary acidic protein [GFAP]) for AD among community-dwelling older adults? Eligible study participants will be randomly enrolled from community-dwelling older adults undergoing routine physical examinations and outpatient clinic attendees. All enrolled participants will undergo AD screening via blood biomarker testing. Participants with positive blood biomarker results (defined as abnormal pTau217/Aβ42 ratio and/or GFAP levels) will further complete a full battery of cognitive scale assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Activities of Daily Living (ADL) scale, and 17-item Hamilton Depression Rating Scale (HAMD-17). In addition, 15% of participants with negative blood biomarker results, selected via random sampling, will also complete the same cognitive scale assessments.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60-80 years
- •Capable of normal communication and able to complete the questionnaire
排除标准
- •Severe mental disorders
- •Severe visual, auditory, comprehension or mobility impairments
- •Current participation in other health intervention clinical studies
- •Severe renal insufficiency, heart failure, cerebrovascular disease, anemia, hyperthyroidism, hypothyroidism
- •Multiple cerebral infarctions, severe white matter hyperintensities, history of cerebral hemorrhage, current anticoagulant use, MRI abnormalities (cortical iron deposition, cerebral contusion)
- •Unable to comply with study procedures with no legal guardian
研究组 & 干预措施
Screening group
干预措施: No study-specific intervention (Other)
结局指标
主要结局
Blood biomarkers （pTau217、Aβ42、GFAP）
时间窗: Baseline (at enrollment)
次要结局
未报告次要终点
研究者
Kuang XiaoJun
Assistant Researcher
Shanghai Fengxian District Central Hospital