Novel Assessment of Synaptic Density in Progressive MS
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|ClinicalTrials.gov Identifier: NCT04634994|
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
PET radiopharmaceutical. Subjects will undergo [F-18]SDM-8 PET Scanning to measure synaptic density.
- 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.
- Standardized uptake values (SUV) [ Time Frame: Through study completion, an average of 1 year ]SUV will be calculated based on standard procedures.
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
|Contact: Tarun Singhal, MDemail@example.com|
|Principal Investigator:||Tarun Singhal, MD||Brigham and Women's Hospital|