Microglial Activation Role In ALS (MARIA)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Concentration of cytokines in cerebrospinal fluid (pg/mL)
研究概览
简要总结
Neuroinflammation, characterized in particular by microglia activation, is an essential component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease activity. An experimental radiopharmaceutical specific of TSPO expression, namely [18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography (PET) imaging.
The purpose of this study is to longitudinally correlate the spatial distribution of neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary approaches in 20 ALS patients:
- in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines secreted by microglial cells in the cerebrospinal fluid (CSF).
- in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.
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
- •Signed informed consent
- •Age ≥ 18 years old
- •Patient with probable or definite sporadic Amyotrophic Lateral Sclerosis (ALS) form according to the modified criteria of El Escorial
- •Treated with riluzole 2 weeks
- •Evolution less than 18 months
- •Mini-Mental State Examination (MMS) score ≥ 26 and Frontal Assessment Battery (FAB) (normal)
- •Affiliated to a social security system
排除标准
- •Another unbalanced progressive pathology
- •Vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced
- •Forced vital capacity <75%
- •Weight loss> 10% of the weight before disease
- •Status "low affinity binder" or "mixed affinity binder", the TSPO respect to the [18 F] DPA-714, which can interfere with the process of neuroinflammation: drugs with anti-inflammatory drugs (NSAIDs, corticosteroids, azathioprine, anti-tumor necrosis factor (TNF), antibiotics)
- •Benzodiazepine in the week before the PET scan [18F] DPA-714 given the potential consequences for TSPO receivers
- •Contraindications to MRI in patients with:
- •Metallic foreign body eye.
- •Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
- •Metal heart valve,
- •Vascular clips formerly located on cranial aneurysm.
- •Treatment in the month before the PET scan [18F] DPA-714 antagonist N-methyl-D-aspartate (NMDA) (memantine)
- •Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy
- •◦Person under guardianship
研究组 & 干预措施
amyotrophic lateral sclerosis (ALS)
[18F]DPA-714 PET
干预措施: [18F]DPA-714 PET (Drug)
结局指标
主要结局
Concentration of cytokines in cerebrospinal fluid (pg/mL)
时间窗: 18 months
次要结局
- Fixation and distribution of [18F]DPA-714 (Binding Potential BP)(18 months)