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Novel Assessment of Synaptic Density in Progressive MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04634994
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
TARUN SINGHAL, Brigham and Women's Hospital

Brief Summary:

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 sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)) as compared to relapsing-remitting multiple sclerosis (RRMS) patients and healthy controls, 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 progressive MS patients, patients with relapsing-remitting MS, 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).


Condition or disease Intervention/treatment Phase
Primary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis Relapsing Multiple Sclerosis Multiple Sclerosis Drug: [F-18]SDM-8 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Assessment of Synaptic Density in Progressive MS
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [F-18]SDM-8 tracer
Subjects will be administered standardized questionnaires for cognitive testing/other co-morbidities. They will undergo PET Scan and 3T Brain MRI. For PET Scan, an intra-arterial catheter will be inserted into the radial artery for [F-18]SDM-8 metabolite blood sampling by a trained anesthesiologist. Allen's test will be performed prior to insertion of the intra-arterial catheter. If arterial line can't be established to obtain metabolite samples, a venous line will be placed. In addition, an intravenous (IV) catheter will be inserted into the radial antecubital or other arm or hand vein for injection of tracer. Radiopharmaceutical will be injected as a bolus (approximately 5mCi for [F-18]SDM-8 followed by 5 mL of saline). The PET session will last up to 120 min. A head support apparatus will be used to minimize head motion. Brain PET data acquisition will begin at the moment of radiotracer injection. For MRI, several pulse sequences will be performed, no IV contrast will be used.
Drug: [F-18]SDM-8
PET radiopharmaceutical. Subjects will undergo [F-18]SDM-8 PET Scanning to measure synaptic density.




Primary Outcome Measures :
  1. Tissue volume of Distribution (Vt) [ Time Frame: Through study completion, an average of 1 year ]
    This will be calculated over whole brain, within white matter, within grey matter, and within MRI-visible lesions.


Secondary Outcome Measures :
  1. Standardized uptake values (SUV) [ Time Frame: Through study completion, an average of 1 year ]
    SUV will be calculated based on standard procedures.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634994


Contacts
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Contact: Tarun Singhal, MD 617-732-5566 tsinghal@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
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Principal Investigator: Tarun Singhal, MD Brigham and Women's Hospital
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Responsible Party: TARUN SINGHAL, Assistant Professor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04634994    
Other Study ID Numbers: 2020P003171
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TARUN SINGHAL, Brigham and Women's Hospital:
multiple sclerosis
MS
PPMS
SPMS
RRMS
Synaptic Density
PET
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases