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RecruitingAccepts healthy volunteersEarly Phase 1

Assessment of Synaptic Density in MS

Brigham and Women's Hospital · with Massachusetts General Hospital · NCT04634994

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
30
US sites recruiting
1
Study start
May 14, 2025
Record last updated
January 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: [F-18]SDM-8

Conditions: Multiple Sclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Steven Cicero · 617-264-3044 · scicero@bwh.harvard.edu

Study contacts (from the official record)

  • Tarun Singhal, MD · 617-264-3043 · tsinghal@bwh.harvard.edu
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Assessment of Synaptic Density in MS (NCT04634994) | Bored Studies