Novel Assessment of Synaptic Density in Progressive MS
Brigham and Women's Hospital
Summary
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).
Description
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: 1. Subjects meeting the definition for PMS (PPMS or SPMS) by International Panel Criteria 2. Subjects meeting the definition for RRMS by the International Panel Criteria, 3. 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 calc…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * 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 wo…
Interventions
- Drug[F-18]SDM-8
PET radiopharmaceutical. Subjects will undergo \[F-18\]SDM-8 PET Scanning to measure synaptic density.
Location
- Brigham and Women's HospitalBoston, Massachusetts