No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
30 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for people with multiple sclerosis (MS) to help researchers learn more about brain activity. Participants will undergo PET and MRI scans and provide blood samples for testing.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with multiple sclerosis (MS).
I can give informed consent.
I am willing to undergo PET and MRI imaging.
I am matched by age and sex to healthy controls.
You may not be able to join if
I have a known alternate neurological disorder.
I have had a head injury.
I have a history of substance abuse.
I have bipolar disorder or schizophrenia.
I have other medical conditions that would prevent me from participating.
I am pregnant or nursing.
I have claustrophobia.
I have an implanted device that is not MRI compatible.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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).
Trial Locations
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Eligibility 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 co…
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
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