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临床试验/NCT04001270
NCT04001270Unknown不适用

Core Cerebrospinal Fluid Biomarker Profile in Leucine Rich Glioma Inactivated 1 (LGI1) Antibody Associated Encephalitis

Hospices Civils de Lyon0 个研究点目标入组 24 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
主要终点
Biomarker levels of leucine rich glioma inactivated 1 associated encephalitis

研究概览

简要总结

Limbic encephalitis associated with anti leucine-rich glioma inactivated-1 LGI1 antibody (anti-LGI1) usually presents with seizures and progressive disturbance of memory and behavior. But anti-LGI1 associated encephalitis (LGI1-E) could present with a variety of features including an elective cognitive form of the disease, which mimicks a neurodegenerative condition such as Creutzfeld Jakob disease or rapidly progressive Alzheimer disease. In these patients, the appropriate diagnosis could be challenging.

The primary aim of this study is to describe cerebrospinal fluid biomarkers in a cohort of LGI1-E patients as results of these markers are currently not described in LGI1-E. Moreover, patients with LGI1-E often present seizures. At this point, the impact on cerebrospinal fluid biomarkers has not been described in this condition. The secondary aims of this study are to compare cerebrospinal fluid (CSF) biomarkers in LGI1-E patients to these in other neurodegenerative conditions ( e.g. creutzfeld Jakob disease, Alzheimer disease), which are considered as a possible differential diagnosis in these patients. The last aim of this study is to look for correlations between cerebrospinal fluid biomarkers in LGI1-E and clinical data in these patients, especially seizure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of well characterized leucine rich glioma inactivated 1 (LGI1) antibody in serum or cerebrospinal fluid (CSF);
  • LGI1 antibody associated encephalitis diagnosis according to the international guidelines;
  • At least one core CSF biomarkers sample (T-tau, P-tau, AB-1-42) available after disease onset;
  • Age at least 18 years old.

排除标准

  • Absence of clinical data

结局指标

主要结局

Biomarker levels of leucine rich glioma inactivated 1 associated encephalitis

时间窗: 3 months

Core CSF biomarkers (T-tau, P-tau, Amyloid β Protein Fragment 1-42 (AB1-42), AB1-40, Neurofilament light chain, in ng/L) will be assessed in LGI1-E patients and will be compared to the profile of patients presenting with common and rapid Alzheimer's disease and with Creutzfeldt Jacob disease (CJD). For each biomarker, statistical comparisions will be made by Kruskal Wallis test then if needed with Wilcoxon Mann Whitney test.

Biomarker levels of anti leucine rich glioma inactivated 1 associated encephalitis

时间窗: 3 months

Prion protein Cerebrospinal Fluid (CSF) levels (ug/L) will be assessed in LGI1-E patients

次要结局

  • Comparison of biomarker profile in anti leucine rich glioma inactivated 1 associated encephalitis (LGI1-E) with versus without faciobrachial dystonic seizures.(two weeks)
  • Comparison of biomarker profile (T-tau, P-tau, Amyloid β Protein Fragment 1-42 (AB1-42), AB1-40, Neurofilament light chain, in nanograms/Liter (ng/L)(two weeks)

研究者

申办方类型
Other
责任方
Sponsor

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