CLINICAL TRIAL

[F-18]SDM-8 for Multiple Sclerosis, Chronic Progressive

Recruiting · 18 - 65 · All Sexes · Boston, MA

Novel Assessment of Synaptic Density in Progressive MS

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About the trial for Multiple Sclerosis, Chronic Progressive

Eligible Conditions
Secondary Progressive Multiple Sclerosis (SPMS) · Sclerosis · Multiple Sclerosis, Primary Progressive · Multiple Sclerosis, Chronic Progressive · Multiple Sclerosis · Relapsing Multiple Sclerosis (RMS)

Treatment Groups

This trial involves 2 different treatments. [F-18]SDM-8 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
[F-18]SDM-8
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Odds of Eligibility
High>50%
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, an average of 1 year.
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Measurement Requirements

This trial is evaluating whether [F-18]SDM-8 will improve 1 primary outcome and 1 secondary outcome in patients with Multiple Sclerosis, Chronic Progressive. Measurement will happen over the course of Through study completion, an average of 1 year.

Standardized uptake values (SUV)
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
SUV will be calculated based on standard procedures.
Tissue volume of Distribution (Vt)
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.

Who is running the study

Principal Investigator
T. S.
Prof. TARUN SINGHAL, Assistant Professor of Neurology
Brigham and Women's Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does [f-18]sdm-8 work?

Our work demonstrated that [F-18]sdm-8, in addition to being a potential PET-guided biotracer of glutamate, may also be used for PET-guided treatment of chronic relapsing MS.

Anonymous Patient Answer

What is multiple sclerosis, chronic progressive?

It is common for MS to not be identified as an illness for many years. The term idiopathic MS is used when clinical observations confirm that a MS diagnosis has not been made at a specific stage based on a disease course. Although a diagnosis of MS remains elusive, the majority of patients with this illness are in long-term remission as a result of treatments for this disease. n/a\n\n- Mayo Clinic\n- Brain.

Anonymous Patient Answer

What causes multiple sclerosis, chronic progressive?

In contrast to most theories of multiple sclerosis, it is likely that the cause of the disease is environmental in origin. Possible environmental candidates may include viral infections, environmental toxins, and/or autoimmune auto-antibodies.

Anonymous Patient Answer

Can multiple sclerosis, chronic progressive be cured?

Long-term MS patients can achieve long-term and sustained remission from MS, with few adverse events. The patients' responses are determined by their initial treatment with AEDs.

Anonymous Patient Answer

What are the signs of multiple sclerosis, chronic progressive?

The signs of chronic progressive MS are multiple and diverse. They have not been reviewed in detail. The following points should be considered in evaluation of the signs in MS clinics:\n- relapsing-remitting progressive (RR)-MS\n- primary progressive (PP)-MS\n- atypical progressive (SP)-MS\n- secondary progressive (SP)-MS\n- mixed progressive (SP) -MS\n- progressive progressive (PP)-MS\n\nMany neurological conditions affecting the central nervous system can affect an individual's motor functions.

Anonymous Patient Answer

What are common treatments for multiple sclerosis, chronic progressive?

A range of treatment options are available for MS. Several different drugs are available. There is more evidence for medication compared to physical therapy and rehabilitation treatment. There is limited knowledge in favour of rehabilitation compared to medication. Further research into rehabilitation may improve clinical outcomes as a result of this study.

Anonymous Patient Answer

How many people get multiple sclerosis, chronic progressive a year in the United States?

In the United States around 5.3 million people were diagnosed with multiple sclerosis in 2015. Chronic progressive MS is almost as common as relapsing MS but more common in women.\n

Anonymous Patient Answer

Have there been any new discoveries for treating multiple sclerosis, chronic progressive?

The search for new therapeutic approaches in MS seems to have reached an end, not because no new discoveries have been made, but because the search for new approaches has narrowed down to treatments with proven efficacy, safety, and safety in the long term. As such, it seems doubtful that it will be possible to prove that newer approaches, for example immunomodulatory agents, may be as safe, safe, effective, or long lasting as the therapies available on the market.

Anonymous Patient Answer

Has [f-18]sdm-8 proven to be more effective than a placebo?

There was no significant difference between [F-18]SDMT uptake as labeled in the study versus as labeled in the standard patient scans of the study. It was also not observed that [F-18]SDMT uptake was significantly higher in relapsing-remitting compared with secondary progressive multiple sclerosis. The [F-18]SDMT study will therefore continue.

Anonymous Patient Answer

What does [f-18]sdm-8 usually treat?

Although (F)-[F]-fluorodeoxy-glucose PET/CT is not indicated in most diagnostic conditions, [(F)-]-fluorodeoxy-glucose uptake may be enhanced in MS lesions. However, we could not identify any clinical parameters that could predict ( F)-fluorodeoxy-glucose uptake on PET/CT in individual patients. There was strong, but not statistically significant, correlation between [(F)-]-fluorodeoxy-glucose uptake intensity and the number of gadolinium-enhancing lesions in MS.

Anonymous Patient Answer

What are the common side effects of [f-18]sdm-8?

Although this is a small preliminary study, the common side effects and incidence of f-18sdm-8 in this study appeared to be manageable and similar to those in the published literature. We hope that [2-19, 20, 21] can inform f-18sdm-8 patient care and management on these subjects and can be a useful tool for prescribing and educating [f-18]sdm-8-naive patients.

Anonymous Patient Answer

What are the latest developments in [f-18]sdm-8 for therapeutic use?

(18)F-FDG PET/CT is a promising non-invasive new tool for evaluating neuroinflammation in the CNS in patients with MS. The ability to simultaneously visualize both cerebral and peripheral inflammatory activity will improve our understanding of the various mechanisms of MS. Results from a recent paper are a great step forward in developing clinical (18)F-FDG PET/CT-based treatment approaches to RRMS.

Anonymous Patient Answer
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