Imaging brain synapse density in people with multiple sclerosis
Novel Assessment of Synaptic Density in Progressive MS
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 |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04634994 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.