RecruitingEarly Phase 1NCT04634994

Assessment of Synaptic Density in MS

Novel Assessment of Synaptic Density in Progressive MS


Sponsor

Brigham and Women's Hospital

Enrollment

30 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is using a specialized brain scan (PET imaging with a tracer called SV2A) to measure the density of synapses (the connections between brain cells) in people with multiple sclerosis (MS). Reduced synapse density may help explain cognitive symptoms like memory and thinking problems in MS. **You may be eligible if...** - You have been diagnosed with multiple sclerosis (any type: relapsing-remitting, primary progressive, or secondary progressive) - You are willing to undergo both a PET scan and an MRI - Healthy volunteers of similar age and sex are also being recruited for comparison **You may NOT be eligible if...** - You have another known neurological disorder, prior head injury, or substance abuse history - You have bipolar disorder or schizophrenia - You are pregnant or nursing, or trying to become pregnant - You have claustrophobia or a metal implant not compatible with MRI - You have taken corticosteroids in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[F-18]SDM-8

PET radiopharmaceutical. Subjects will undergo \[F-18\]SDM-8 PET Scanning to measure synaptic density.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT04634994


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