Recruiting
Early Phase 1

F-18SDM-8

Sponsor:

Brigham and Women's Hospital

Code:

NCT04634994

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

[F-18]SDM-8

Study Details

Brief 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).

Conditions

Multiple Sclerosis

Study ID

NCT04634994

Start date

May 14, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PMS, RRMS, and Healthy Control Subjects

Interventions

[F-18]SDM-8

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

Primary outcome measure

  • PET measurements in individuals with PMS, RRMS, and healthy controls [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Tarun Singhal, MD

617-264-3043tsinghal@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Steven Cicero

617-264-3044scicero@bwh.harvard.edu

Principal Investigator:

Tarun Singhal, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • Multiple Sclerosis
  • MS
  • Synaptic Density
  • Positron Emission Tomography
  • PET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-01-09.