Community-based Screening for Alzheimer's Disease (CSAD)
Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Xiaojun Kuang, PhD
- 电话号码：021-57426172
- 邮箱：xj_kuang@126.com
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国
- 招聘中
- Fengcheng Community Health Service Center
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接触：
- Zhongming Sheng
- 电话号码：021-57131233
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Shanghai、Shanghai Municipality、中国
- 招聘中
- Fengpu Community Health Service Center
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接触：
- Zhiping Jin
- 电话号码：021-37136190
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Shanghai、Shanghai Municipality、中国
- 招聘中
- Qingcun Community Health Service Center
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接触：
- Jingxin Zhu
- 电话号码：021-57561250
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Shanghai、Shanghai Municipality、中国
- 招聘中
- Xidu Community Health Service Center
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接触：
- Xiaoqing Gu
- 电话号码：021-37130155
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Aged 60-80 years
- Capable of normal communication and able to complete the questionnaire
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Screening group
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This is a purely observational cohort study with no intervention assigned to participants.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Blood biomarkers （pTau217、Aβ42、GFAP）
大体时间：Baseline (at enrollment)
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Baseline (at enrollment)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.