Effect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PET Uptake/Standardized uptake value ratio (SUVR) change
研究概览
简要总结
Specific Aims
The specific aims of the study are:
- Primary Objective: To assess the effect of alemtuzumab on microglial activation in MS patients. The hypothesis is that alemtuzumab reduces microglial activation in MS, which may mediate its effect on reducing conversion of RRMS patients to SPMS, and its effects on cognition, including cognitive fatigue.
- Secondary Objective: To determine the time course of effect of alemtuzumab on microglial activation. The hypothesis is that alemtuzumab reduces microglial activation at 6 months after initiation of treatment and this effect persists and is accentuated at 18 years, i.e. after administration of the second course
详细描述
I. Subject Selection
Subjects will be recruited at the Partners MS Center, 60 Fenwood Road, Boston, MA. In addition, referrals for the study will be obtained from MS Center at University of Massachusetts Medical center, Worcester, MA. Subjects will also be recruited through Health and Clinical Research OnCall websites, and from individual physician references.
II. Study Procedures
Initial Visit:
During the first visit, subjects will be adminsitered a screening questionnaire. Subjects will review and eventually sign the consent form. They will be administered standardized questionnaires for cognitive testing and/or other co-morbidities. In addition, a blood sample will be drawn for genotype testing to identify high affinity, medium affinity and low affinity binders.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (defined by International Panel Criteria)
- •Age 18-60 years
- •Enrolled to start treatment with alemtuzumab
排除标准
- •Relapse/Corticosteroid treatment in the past 4 weeks to avoid transient effects on imaging
- •Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- •Individuals with bipolar disease and schizophrenia
- •Concurrent medical conditions that contraindicate study procedures.
- •Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
- •Claustrophobia
- •Non-MRI compatible implanted devices
- •Low affinity binder
研究组 & 干预措施
Relapsing Remitting Multiple Sclerosis starting Alemtuzumab
Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (defined by International Panel Criteria), age 18-60 years, enrolled to start treatment with alemtuzumab.
Subjects will undergo [F-18]PBR06 PET scans at baseline, 6 months and 18 months.
干预措施: [F-18]PBR06 (Drug)
结局指标
主要结局
PET Uptake/Standardized uptake value ratio (SUVR) change
时间窗: baseline and 18 months
PET outcome measure change at 18 months from baseline
次要结局
- Minimal Assessment of Cognitive Function in MS (MACFIMS) change(baseline and 18 months)
- Whole brain/deep gray matter atrophy change(baseline and 18 months)
- Expanded Disability Status Scale (EDSS) change(baseline and 18 months)
- PET Uptake/Standardized uptake value ratio (SUVR) change(baseline and 6 months)
- T2/FLAIR lesion load change(baseline and 18 months)
- Timed 25-foot walk (T25FW) change(baseline and 18 months)
- Modified Fatigue Impact Scale (MIFS) change(baseline and 18 months)
研究者
TARUN SINGHAL
Assistant Professor of Neurology
Brigham and Women's Hospital