Imaging brain synapse density in people with multiple sclerosis
Official title: Novel Assessment of Synaptic Density in Progressive MS
Run by Brigham and Women's Hospital · NCT04634994 · Data updated 2026-11-12
This study will test whether a new PET tracer ([F-18]SDM-8) can measure synaptic (brain connection) loss in people with progressive and relapsing MS compared with healthy volunteers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | May 14, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT04634994 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed MS (PPMS, SPMS, or RRMS) who can safely undergo PET and MRI, are able to give informed consent, and are willing to travel to the study site are ideal candidates.
✕Probably not a fit
People with other neurologic disorders, recent corticosteroid use, pregnancy or breastfeeding, severe psychiatric illness, claustrophobia, or non‑MRI‑compatible implanted devices will likely be excluded and therefore will not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, early phase 1, cross-sectional study will use the novel SV2A PET ligand [F-18]SDM-8 to image cortical and subcortical synaptic density in groups with progressive MS (PPMS or SPMS), relapsing-remitting MS (RRMS), and healthy controls. Researchers will compare regional synaptic density between groups and correlate PET findings with standard 3T MRI measures (brain atrophy, lesion load) and clinical measures of disability, cognition, fatigue, and depression. The study will also explore relationships between synaptic PET signal and serum neurofilament light chain levels. About 30 evaluable subjects (target enrollment ~40 to allow for screen failures) will be recruited and may attend up to four in-person visits at Brigham and Women's Hospital.
Why it matters
Potential benefit: If successful, this imaging method could provide a sensitive biomarker to detect synaptic loss and help track disease progression or treatment effects in MS.
How similar studies have gone: Related SV2A PET tracers (for example [11C]UCB-J and [18F]UCB-H) have successfully measured synaptic loss in other neurodegenerative conditions and early work suggests applicability to MS, while use of [F-18]SDM-8 is a newer, less-tested approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Tarun Singhal, MD — Brigham and Women's Hospital
- Study coordinator: Tarun Singhal, MD
- Email: tsinghal@bwh.harvard.edu
- Phone: 617-264-3043
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.