Multiple Sclerosis study: [F-18]SDM-8
Official title Assessment of Synaptic Density in MS
ClinicalTrials.gov ID: NCT04634994
What this study is testing
What is [F-18]SDM-8?
an investigational PET radiopharmaceutical being studied to measure synaptic density in multiple sclerosis
Also referred to as [F-18]SynvesT-1.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how many nerve connections are left in the brains of people with progressive multiple sclerosis. It also looks at how these connections relate to brain shrinkage, blood tests, and daily symptoms.
- Who it's for
- The study is looking for adults with progressive multiple sclerosis, as well as people with relapsing-remitting multiple sclerosis and healthy volunteers for comparison.
- What's involved
- Participants will have a PET scan (a type of imaging that shows brain activity) and a standard MRI. They will also give blood samples and answer questions about their health and daily life.
- Time commitment
- The study involves one main visit for the scans and blood tests, with follow-up visits to track changes over time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- people meeting the definition for MS (including PPMS, RRMS or SPMS) by International Panel (2017 McDonald) Criteria.
- people willing to undergo PET and MRI imaging
- people willing and able to give informed consent
You likely can't join if
- 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
See the full eligibility criteria
- people 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.
- people willing to undergo PET and MRI imaging
- people willing and able to give informed consent
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.