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Assessment of Synaptic Density in MS

RECRUITINGEarly 1Sponsored by Brigham and Women's Hospital
Actively Recruiting
PhaseEarly 1
SponsorBrigham and Women's Hospital
Started2025-05-14
Est. completion2026-12-31
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04634994

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

Age: 18 Years – 60 YearsHealthy volunteers accepted
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 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

Conditions1

Multiple Sclerosis

Locations1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Steven Cicero617-264-3044scicero@bwh.harvard.edu

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