[F-18]SDM-8 for Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for examining brain activity in people with multiple sclerosis (MS). The study uses a special tool called [F-18]SDM-8, an imaging agent, to create images that reveal the functionality of the brain's connections. It compares individuals with different types of MS to healthy individuals to observe how MS affects the brain over time. This trial may suit someone diagnosed with progressive or relapsing MS who is willing to undergo brain scans. As an Early Phase 1 trial, this research aims to understand how the imaging agent functions in people, offering participants a chance to contribute to groundbreaking insights into MS.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had corticosteroid treatment in the past four weeks.
What prior data suggests that this imaging technique is safe for assessing synaptic density in multiple sclerosis?
Research has shown that [F-18]SDM-8, also known as [F-18]SynVesT-1, has been tested in early studies. These studies found it effective and without major issues in animal models, such as monkeys.
Since the trial for multiple sclerosis is just beginning, information about its safety in humans remains limited. This early phase focuses on assessing the treatment's safety and understanding its behavior in the body. If [F-18]SDM-8 proves safe in these initial trials, it will advance to more detailed studies to confirm its safety and effectiveness in people. Interested individuals should discuss potential risks with the trial team or their doctor.12345Why are researchers excited about this trial?
Most treatments for multiple sclerosis (MS), like interferons and monoclonal antibodies, focus on suppressing the immune system to reduce inflammation and slow disease progression. But [F-18]SDM-8 works differently, targeting synaptic density in the brain. This unique approach could provide new insights into how MS affects brain function, potentially leading to more precise and personalized treatments. Researchers are excited because understanding synaptic changes may open the door to new ways of diagnosing and monitoring MS, beyond just managing symptoms.
What evidence suggests that this novel imaging technique is effective for assessing synaptic density in progressive multiple sclerosis?
Research has shown that the SV2a-PET marker, [F-18]SDM-8, measures the number of connections between nerve cells in the brain, known as synaptic density. These connections are crucial for brain function. [F-18]SDM-8 has provided clearer images of these connections, particularly in aging and Alzheimer's disease. In this trial, researchers are investigating [F-18]SDM-8 in participants with primary and relapsing-remitting multiple sclerosis (MS), as well as healthy control subjects. This suggests it might be useful for studying MS, a condition where these nerve connections can be damaged. Understanding synaptic density in MS could help link changes in the brain to symptoms like disability, fatigue, and depression.678910
Who Is on the Research Team?
Tarun Singhal, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for individuals with Multiple Sclerosis (MS), including those with primary progressive MS (PPMS) and secondary progressive MS (SPMS). It's also open to healthy people matched by age and sex. Participants must be willing to undergo PET and MRI scans and able to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Visit
Subjects are administered the screening questionnaire, review and sign the consent form, and complete standardized questionnaires for cognitive testing and/or other co-morbidities.
PET Visit
Subjects undergo a PET scan with radiopharmaceutical injection and pregnancy testing for women of childbearing age.
MRI Visit
Subjects undergo a 3T Brain MRI scan, with pregnancy screening for women.
Follow-up
Participants are monitored for safety and effectiveness after imaging procedures.
What Are the Treatments Tested in This Trial?
Interventions
- [F-18]SDM-8
Trial Overview
[F-18]SDM-8, a novel PET ligand, is being tested to measure synaptic density in the brain of patients with different types of MS compared to healthy subjects. The study will explore how these measures relate to physical disability, cognitive issues, fatigue, depression, brain atrophy, lesion load on MRI scans, serum neurofilament light chain levels, and inflammatory markers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborator
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT04634994?intr=synaptic&aggFilters=studyType:int&viewType=Table&rank=5&checkSpell=Novel Assessment of Synaptic Density in Progressive MS
The investigators propose to use the novel SV2a-PET ligand, [F-18]SDM-8 to assess synaptic density in progressive MS (including primary progressive multiple ...
Novel Assessment of Synaptic Density in Progressive MS
The investigators propose to use the novel SV2a-PET ligand, [F-18]SDM-8 to assess synaptic density in progressive MS (including primary ...
Imaging synaptic density in ageing and Alzheimer's ...
Subsequent SV2A PET ligands radiolabeled with the 18F isotope have been developed, with [18F]-SynVesT-1 (also known as [18F]-SDM8) shown to have ...
Outcome Measures in Relapsing-Remitting Multiple Sclerosis
This review will define outcome measures and surrogate endpoints, discuss the metrics that have been used to date in MS trials, and present challenges
Primary Progressive Multiple Sclerosis (PPMS)
A multiple sclerosis that is characterized by steady worsening of neurologic functioning, without any distinct relapses or periods of remission.
First-in-Human Evaluation of 18F-SynVesT-1, a ... - PubMed
We developed a new tracer, an 18F-labeled difluoro-analog of UCB-J (18F-SynVesT-1, also known as 18F-SDM-8), which displayed favorable properties in monkeys.
GMP-compliant automated radiosynthesis of [18F] SynVesT-1 ...
Retention time of the [19F] SynVesT-1 ((R)-SDM-8) reference was 24.702 min, and [18F] SynVesT-1 eluted at 25.274 min without any other ...
Reduced SV2A and GABAA receptor levels in the brains of ...
Reduced SV2A and GABAA receptor levels in the brains of type 2 diabetic rats revealed by [18F]SDM-8 and [18F]flumazenil PET. Author links open overlay panel
9.
ppmi-info.org
ppmi-info.org/sites/default/files/docs/PPMI%20SV2A%20PET%20Imaging%20Protocol_v1.0_28Feb2023_Final.pdfLongitudinal [18F]SynVesT-1 PET targeting SV2A in PPMI ( ...
This tracer, previously known as [18F]MNI-1126 was developed independently from [18F]SDM-8 (Li et al. 2019), although sharing the same.
10.
researchgate.net
researchgate.net/publication/343967603_First-in-human_evaluation_of_18_F-SynVesT-1_a_novel_radioligand_for_PET_imaging_of_synaptic_vesicle_protein_2AFirst-in-human evaluation of 18 F-SynVesT-1, a novel ...
We developed a new tracer, an 18F-labeled difluoro-analog of UCB-J (18F-SynVesT-1, a.k.a. 18F-SDM-8), which displayed favorable properties in ...
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