Novel Assessment of Synaptic Density in Progressive MS
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PET measurements in individuals with PMS, RRMS, and healthy controls
研究概览
简要总结
The investigators propose to use the novel SV2a-PET ligand, [F-18]SDM-8 to assess synaptic density in progressive multiple sclerosis (PMS) (including primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)), given its improved imaging characteristics and potential for large scale applicability.
The specific aims of the study are:
Aim 1: To compare the cortical and subcortical grey matter synaptic density in PMS patients, patients with relapsing-remitting MS (RRMS), and healthy subjects, using a novel [F-18] labeled synaptic density PET ligand, [F-18]SDM8, also known as [F-18]SynvesT-1.
Aim 2: To compare the relationship of synaptic density PET and standard 3T MRI measures including global and regional brain atrophy and lesion load with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS patients.
Aim 3: To assess the relationship of synaptic density PET with serum neurofilament light chain (NfL) and with serum measurements of inflammatory markers, IL-1β, TNF-α, IL-6, MCP-1 (Monocyte Chemoattractant Protein-1) and MIF-1 (Macrophage Migration Inhibitory Factor-1).
详细描述
This is a single center, cross-sectional study of synaptic density measurement in patients with progressive MS as compared to RRMS and healthy controls.
Three groups of subjects will be recruited:
- Subjects meeting the definition for PMS (PPMS or SPMS) by International Panel Criteria
- Subjects meeting the definition for RRMS by the International Panel Criteria,
- Healthy Controls
Sample Size: We plan to enroll 40 subjects including at least 10 with PMS (PPMS or SPMS), 10 with RRMS and 10 healthy controls. This is a pilot study and the sample size estimations are not based on power calculations. In order to attain our goal sample size of 30 subjects, we estimate that we may need to enroll approximately 40 subjects to account for screen failures.
Physicians at the Brigham MS Center may present the study to a subject during a regular scheduled clinic visit. If the subject is interested in the study, a copy of the consent form will be given. The subject will then be contacted by telephone prior to the screening visit appointment. At the time of the subject's screening visit, an investigator will go over the study in detail, answer any questions the subject may have regarding the study and a licensed physician investigator will obtain informed consent. In accordance with NIH guidelines, efforts will be made to attain a mix of study participants, in terms of gender and racial/ethnic representation.
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
- 是
入选标准
- •Subjects meeting the definition for MS (including PPMS, RRMS or SPMS) by International Panel (2017 McDonald) Criteria. Age and sex-matched healthy controls will also be recruited.
- •Subjects willing to undergo PET and MRI imaging
- •Subjects willing and able to give informed consent
排除标准
- •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
- •Corticosteroid treatment in the past four weeks
研究组 & 干预措施
PMS, RRMS, and Healthy Control Subjects
干预措施: [F-18]SDM-8 (Drug)
结局指标
主要结局
PET measurements in individuals with PMS, RRMS, and healthy controls
时间窗: Baseline
To compare PET measurements including standardized uptake value (SUV) and standardized uptake value ratio (SUVR) in individuals with PMS, RRMS, and healthy controls.
次要结局
- Correlations between PET measurements and clinical, MRI, and blood and serum measures(Baseline)
研究者
TARUN SINGHAL
Associate Professor of Neurology
Brigham and Women's Hospital