Neurofilament Light Chain and Cognitive Impairment as Diagnostic and Prognostic Markers in naïve Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- The primary outcome is the detection of neurofilament light chain as diagnostic and prognostic inflammatory markers in newly diagnosed MS patients.
研究概览
简要总结
Neurofilament protein detected in the serum appears to be a good marker for the extent of active neurodegeneration. Chitinase may also be a good marker reflecting the degree of astrocyte activation, or damage in active lesions (Paul et al, 2018).These markers have some clinical value for diagnosis and monitoring of disease activity. NfL can be objectively measured and quantified, it is highly sensitive to neurodegenerative processes and its concentration changes as the disease worsens or improves (Disanto et al., 2017). Numerous studies have shown that NfL levels increase during MS relapses and correlate with MRI lesion development (Disanto et al., 2016, 2017; Novakova et al., 2017), disease activity, (Thebault et al., 2020). Cognitive impairment is common in the early stages of multiple sclerosis, mainly affecting attention, working memory, and information processing speed, but also memory, inhibition, and conceptualisation. Poor performance is common but remains subtle and does not significantly affect the quality of life at this stage. However, many studies shows that these deficits reflect the destruction both within and outside lesions, and that they may therefore be considered as a severity marker in the early stages of multiple sclerosis. (Lengenfelder et al., 2005).
The aim of the work is to detect the role of serum NFL and chitinase as biomarkers in the diagnosis and prognosis of newly diagnosed multiple sclerosis patients, and to estimate the incidence of cognitive impairment and their relationship with the NFL in newly diagnosed MS patients.
详细描述
Many immunological studies have been performed with the aim to identify MS specific biomarkers and disease mechanisms and to find markers able to predict clinical disease course and outcome (Housley et al, 2015) Besides MRI and markers related to therapy (induction of blocking antibodies) or JC virus infection, they include markers for neurodegeneration, such as neurofilaments, markers for astrocytic activation (eg. chitinase or GFAP). Neurofilament protein detected in the serum or cerebrospinal fluid appears to be a good marker for the extent of active neurodegeneration, but this is not MS specific. Chitinase may be a good marker for active disease in RRMS, reflecting the degree of astrocyte activation, or damage in active lesions (Paul et al, 2018).These markers have some clinical value for diagnosis and monitoring of disease activity. Cognitive impairment is common in the early stages of multiple sclerosis, mainly affecting attention, working memory, and information processing speed, but also memory, inhibition, and conceptualisation. Poor performance is common but remains subtle and does not significantly affect the quality of life at this stage. However, many studies shows that these deficits reflect the destruction both within and outside lesions, and that they may therefore be considered as a severity marker in the early stages of multiple sclerosis. (Lengenfelder et al., 2005).Aim of the work The aim of the work is to detect the role of serum neurofilament light chain and chitinase as well as cognitive impairment as biomarkers in the diagnosis and prognosis of newly diagnosed multiple sclerosis patients, and to estimate the incidence of cognitive impairment and their relationship with the NFL in newly diagnosed MS patients.Study Design This study is a cross-sectional, prospective, observational study. Subjects All newly diagnosed cases With MS patients attending different MS unites in Assiut governorate will be recruited and all eligible patients will be included.
Inclusion criteria:
All patients newly diagnosed MS according to the 2017-McDonalds criteria.
Exclusion criteria:
- patients who are already diagnosed as MS and on treatment.
- Presence of other disorder or on medications that may affect the neurological or cognitive disorders.
- Patients failed to commit to the follow up visits and regular MRI scans
- Patients refused to sign the written informed consent
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients newly diagnosed MS according to the 2017-McDonalds criteria.
- •Exclusion criteria:
- •patients who are already diagnosed MS and under DMTs treatment
- •Presence of other disorder or on medications that may affect the neurological or cognitive disorders.
- •Patients failed to commit to the follow up visits and regular MRI scans
- •Patients refused to sign the written informed consent
排除标准
- 未提供
结局指标
主要结局
The primary outcome is the detection of neurofilament light chain as diagnostic and prognostic inflammatory markers in newly diagnosed MS patients.
时间窗: 1 and half year
Assessment of the serum level of NFL at base line before starting DMT and correlate it with motor disability, cognitive impairment after one and half year
次要结局
- Assessment of the incidence of cognitive impairment among naive multiple sclerosis patients and their correlation with neurofilment light chain(1 and half year)
研究者
Eman M. Khedr
professor of Neurology
Assiut University