NCT06304129尚未招募不适用
Threshold Values and Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers
Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2024年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Aβ40 and Aβ42, P-Tau, Tau and NFL
研究概览
简要总结
.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:
- to define a threshold value for each of the plasma,
- to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
- to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
- to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 18 or over
- •Person affiliated to a social security scheme or beneficiary of such a scheme
- •Person who has received full information on the organization of the research and has signed an informed consent form
- •Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease
排除标准
- •Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- •An adult unable to give consent
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons under psychiatric care under articles L. 3212-1 and L. 3213-
- •Pregnant, parturient or breast-feeding women
- •Persons staying in a health or social establishment for purposes other than research.
结局指标
主要结局
Aβ40 and Aβ42, P-Tau, Tau and NFL
时间窗: 2 years
Peptides Aβ40 and Aβ42, P-Tau and NFL, assayed in plasma. Peptides Aβ40 and Aβ42, Tau and P-Tau assayed in CSF
次要结局
- Final diagnosis(2 years)
- Sensitivity/specificity(2 years)
- Co-mobidity(2 years)
研究者
Catherine MALAPLATE
Dr
Central Hospital, Nancy, France
研究点 (2)
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