Multiple SclerosisNCT06591429
Smoldering Inflammation in MS
An observational study of Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS). The main questions it aims to answer are: How does abnormal neural inflammation compare to cellular and molecular inflammation in MS? Once treated, why does abnormal inflammation persist? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Radiotracer [11C]-CS1P1, Radiotracer [11C]-DPA-713 and anti-CD20 MS treatment
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25 adult patients with relapsing remitting multiple sclerosis will be enrolled in this study. Patients will be recruited from the John L. Trotter MS Center at Washington University in St. Louis. Participants will be referred to the study by their treating neurologist.
Who may be able to join
- Male or female, any race
- Age ≥ 18 years
- Capable of providing written informed consent for volunteering to undergo research procedures
- Diagnosis of MS as established by the referring physician and confirmed by the Sponsor-Investigator. Only patients with active disease, defined as at least 1 enhancing lesion present in the preceding 6 months, will be enrolled
- Treatment naïve except for relapse-related treatments such as corticosteroids or plasmapheresis,
- Planned initiation, at the discretion of the referring physician, of a high efficacy DMT. High efficacy DMT will be defined to include ocrelizumab, natalizumab, or any MS treatment in the opinion of the Sponsor-Investigator to have similar efficacy as the named treatments
- Clinical labs, including at least a CBC and BMP, without significant abnormality as determined by the Sponsor-Investigator or designee, within the 3 months prior to enrollment
Who cannot join
- Presence of a low binding polymorphism for TSPO
- Hypersensitivity to [11C]-CS1P1, [11C]-DPA-713, [18F]-FDG, or any of their excipients
- Contraindications to PET, CT or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate
- eGFR less than 60 (for gadolinium)
- Severe claustrophobia
- Women who are currently pregnant or breast-feeding
Show all 11Show fewer
- Currently undergoing radiation therapy
- Insulin dependent diabetes
- Contraindication to lumbar puncture (LP), including use of antiplatelet therapy (other than aspirin 81mg), therapeutic anticoagulation, or space occupying intracranial mass. History of a coagulopathy is also exclusionary
- Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data (e.g., renal or liver failure, advanced cancer)
- Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed 5 rem
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnes Jewish Center for Clinical Imaging Research
St Louis, Missouri, 63110
Matthew R Brier, MD, PhD, 314-362-7666, brierm@wustl.edu
Nicole E Shelley, MA, nshelley@wustl.edu
About this study
Official title: Investigation of Smoldering Inflammation in Multiple Sclerosis
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS). The main questions it aims to answer are:
- How does abnormal neural inflammation compare to cellular and molecular inflammation in MS?
- Once treated, why does abnormal inflammation persist?
Read the detailed description
The purpose of this study is to combine multi-tracer PET and high-resolution CSF analysis to understand the inflammatory landscape of MS and to identify components of inflammation which do not resolve with high-efficacy DMT and are hypothesized to drive disability accumulation via smoldering inflammation. Identification of components of the pathologic cascade which do not respond to extant therapies will motivate future, complementary therapies targeted at yet untreated MS pathology.
Current MS disease modifying therapies (DMT) focus on reducing the inflammatory or auto-immune component of the disease. Highly effective DMTs are incredibly effective at reducing this inflammation such that new lesions and clinical relapses are increasingly rare. However, despite these advances, most patients will experience clinical worsening independent of relapse activity. This eventually manifests as progressive MS and stubbornly resists therapy. One hypothesized driver of this clinical progression is smoldering inflammation. Smoldering inflammation is defined as ongoing inflammation sufficient to cause accumulating tissue injury but insufficient to cause clinical relapse. The nature of this smoldering inflammation is poorly understood. Emerging imaging biomarkers have identified smoldering inflammation, but those markers are not well-linked to cellular mechanisms. A key innovation of this approach is that, by comparing pre- vs. post-treatment single-cell RNA sequencing data, the researchers will identify cell populations that are most sensitive and resistant to treatment and relate these findings to imaging changes. Identifying components of persistent inflammation may identify future treatment targets.
25 adult patients with relapsing remitting multiple sclerosis will be enrolled in this study. Patients will be recruited from the John L. Trotter MS Center at Washington University in St. Louis. Participants will be referred to the study by their treating neurologist.
[11C]-CS1P1 and [11C]-DPA-713 are the investigational radiotracers used in this study. Participation in this study consists of several visits. Visits include 1) (pre-)screening and clinical, 2) baseline lumbar puncture, 3) baseline [11C]-DPA-713 PET/CT, 4) baseline [11C]-CS1P1 PET/CT, 5) baseline [18F]-FDG PET/MRI, 6) follow-up lumbar puncture, 7) follow-up [11C]-DPA-713 PET/CT, 8) follow-up [11C]-CS1P1 PET/CT, and 9) follow-up [18F]-FDG PET/MRI. Baseline and follow-up visits of the same type (e.g., steps 3 and 7) are identical with baseline occurring at enrollment and follow-up occurring at least nine months but no more than 12 months after DMT initiation. Screening session must precede the clinical sessions. At each the baseline and follow-up time point, the lumbar puncture and each imaging session may occur in any order. At baseline and follow up, all sessions will take place within approximately 1 month. Multiple sessions can occur on the same day. Consecutive imaging sessions will be separated by 6 half-lives of the initially injected radiotracer.
This pilot study will link the molecular specificity and high spatial resolution of combined positron emission tomography and magnetic resonance imaging with the molecular explanatory power of single-cell RNA sequencing to investigate the effects of B cell depletion, or other similarly efficacious treatments, on smoldering inflammation and characterize the nature of persistent inflammation which contributes to disability in patients with MS. A key innovation of this approach is that, by comparing pre- vs. post-treatment single-cell RNA sequencing data, researchers will identify cell populations that are most sensitive and resistant to treatment and relate these findings to imaging changes. Identifying components of persistent inflammation may identify future treatment targets.
- Conditions
- Multiple Sclerosis
- Being tested
- Radiotracer [11C]-CS1P1, Radiotracer [11C]-DPA-713, anti-CD20 MS treatment, Radiotracer [12F]-FDG
- Keywords
- Multiple Sclerosis, Imaging, Inflammation
- Medical subject headings
- Multiple Sclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotracer [11C]-CS1P1Radiation
Radiotracer used in PET/CT scans of the head and neck Dose range: 12-17 mCi
Radiotracer [11C]-DPA-713Radiation
Radiotracer used in PET/CT scans of the head and neck Dose range:15-20 mCi
anti-CD20 MS treatmentDrug
MS treatment taken indepenently after initial testing
Radiotracer [12F]-FDGRadiation
used in PET/CT scans of the head and neck Dose: 5-7 mCi
| Study group | Role | What they receive |
|---|---|---|
| Participants | Adults with MS taking part in this study. Receives: Radiation: Radiotracer [11C]-CS1P1; Radiation: Radiotracer [11C]-DPA-713; Drug: anti-CD20 MS treatment; Radiation: Radiotracer [12F]-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Distribution (Vt) of DPA-713 and CS1P1 and Cerebral metabolic rate of glucose (CMRglc) in white matter lesions and normal appearing white matter before and after treatment.
Measured: 1 year
Changes in scRNAseq measures of inflammatory cell types in the CSF before and after treatment
Measured: 1 year
Secondary outcomes (1)
Correlation between changes in Vt or CMRglc compared to changes in cell type numbers from scRNAseq
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brier, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591429
- Sponsor's protocol ID
- 202403168
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
PubMed 28002679Maggi P, Sati P, Nair G, Cortese ICM, Jacobson S, Smith BR, Nath A, Ohayon J, van Pesch V, Perrotta G, Pot C, Theaudin M, Martinelli V, Scotti R, Wu T, Du Pasquier R, Calabresi PA, Filippi M, Reich DS, Absinta M. Paramagnetic Rim Lesions are Specific to Multiple Sclerosis: An International Multicenter 3T MRI Study. Ann Neurol. 2020 Nov;88(5):1034-1042. doi: 10.1002/ana.25877. Epub 2020 Sep 9.
PubMed 32799417Endres CJ, Pomper MG, James M, Uzuner O, Hammoud DA, Watkins CC, Reynolds A, Hilton J, Dannals RF, Kassiou M. Initial evaluation of 11C-DPA-713, a novel TSPO PET ligand, in humans. J Nucl Med. 2009 Aug;50(8):1276-82. doi: 10.2967/jnumed.109.062265. Epub 2009 Jul 17.
PubMed 19617321Brier MR, Hamdi M, Rajamanikam J, Zhao H, Mansor S, Jones LA, Rahmani F, Jindal S, Koudelis D, Perlmutter JS, Wong DF, Nickels M, Ippolito JE, Gropler RJ, Schindler TH, Laforest R, Tu Z, Benzinger TLS. Phase 1 Evaluation of 11C-CS1P1 to Assess Safety and Dosimetry in Human Participants. J Nucl Med. 2022 Nov;63(11):1775-1782. doi: 10.2967/jnumed.121.263189. Epub 2022 Mar 24.
PubMed 35332093Lassmann H, van Horssen J, Mahad D. Progressive multiple sclerosis: pathology and pathogenesis. Nat Rev Neurol. 2012 Nov 5;8(11):647-56. doi: 10.1038/nrneurol.2012.168. Epub 2012 Sep 25.
PubMed 23007702Hemond CC, Baek J, Ionete C, Reich DS. Paramagnetic rim lesions are associated with pathogenic CSF profiles and worse clinical status in multiple sclerosis: A retrospective cross-sectional study. Mult Scler. 2022 Nov;28(13):2046-2056. doi: 10.1177/13524585221102921. Epub 2022 Jun 24.
PubMed 35748669Mahad DH, Trapp BD, Lassmann H. Pathological mechanisms in progressive multiple sclerosis. Lancet Neurol. 2015 Feb;14(2):183-93. doi: 10.1016/S1474-4422(14)70256-X.
PubMed 25772897
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Smoldering Inflammation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06591429
- Acronym / sponsor ID
- 202403168
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Imaging, Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS). The main questions it aims to answer are:
- How does abnormal neural inflammation compare to cellular and molecular inflammation in MS?
- Once treated, why does abnormal inflammation persist?
Detailed description
The purpose of this study is to combine multi-tracer PET and high-resolution CSF analysis to understand the inflammatory landscape of MS and to identify components of inflammation which do not resolve with high-efficacy DMT and are hypothesized to drive disability accumulation via smoldering inflammation. Identification of components of the pathologic cascade which do not respond to extant therapies will motivate future, complementary therapies targeted at yet untreated MS pathology.
Current MS disease modifying therapies (DMT) focus on reducing the inflammatory or auto-immune component of the disease. Highly effective DMTs are incredibly effective at reducing this inflammation such that new lesions and clinical relapses are increasingly rare. However, despite these advances, most patients will experience clinical worsening independent of relapse activity. This eventually manifests as progressive MS and stubbornly resists therapy. One hypothesized driver of this clinical progression is smoldering inflammation. Smoldering inflammation is defined as ongoing inflammation sufficient to cause accumulating tissue injury but insufficient to cause clinical relapse. The nature of this smoldering inflammation is poorly understood. Emerging imaging biomarkers have identified smoldering inflammation, but those markers are not well-linked to cellular mechanisms. A key innovation of this approach is that, by comparing pre- vs. post-treatment single-cell RNA sequencing data, the researchers will identify cell populations that are most sensitive and resistant to treatment and relate these findings to imaging changes. Identifying components of persistent inflammation may identify future treatment targets.
25 adult patients with relapsing remitting multiple sclerosis will be enrolled in this study. Patients will be recruited from the John L. Trotter MS Center at Washington University in St. Louis. Participants will be referred to the study by their treating neurologist.
[11C]-CS1P1 and [11C]-DPA-713 are the investigational radiotracers used in this study. Participation in this study consists of several visits. Visits include 1) (pre-)screening and clinical, 2) baseline lumbar puncture, 3) baseline [11C]-DPA-713 PET/CT, 4) baseline [11C]-CS1P1 PET/CT, 5) baseline [18F]-FDG PET/MRI, 6) follow-up lumbar puncture, 7) follow-up [11C]-DPA-713 PET/CT, 8) follow-up [11C]-CS1P1 PET/CT, and 9) follow-up [18F]-FDG PET/MRI. Baseline and follow-up visits of the same type (e.g., steps 3 and 7) are identical with baseline occurring at enrollment and follow-up occurring at least nine months but no more than 12 months after DMT initiation. Screening session must precede the clinical sessions. At each the baseline and follow-up time point, the lumbar puncture and each imaging session may occur in any order. At baseline and follow up, all sessions will take place within approximately 1 month. Multiple sessions can occur on the same day. Consecutive imaging sessions will be separated by 6 half-lives of the initially injected radiotracer.
This pilot study will link the molecular specificity and high spatial resolution of combined positron emission tomography and magnetic resonance imaging with the molecular explanatory power of single-cell RNA sequencing to investigate the effects of B cell depletion, or other similarly efficacious treatments, on smoldering inflammation and characterize the nature of persistent inflammation which contributes to disability in patients with MS. A key innovation of this approach is that, by comparing pre- vs. post-treatment single-cell RNA sequencing data, researchers will identify cell populations that are most sensitive and resistant to treatment and relate these findings to imaging changes. Identifying components of persistent inflammation may identify future treatment targets.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Radiation: Radiotracer [11C]-CS1P1, Radiation: Radiotracer [11C]-DPA-713, Drug: anti-CD20 MS treatment, Radiation: Radiotracer [12F]-FDGAdults with MS taking part in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 adult patients with relapsing remitting multiple sclerosis will be enrolled in this study. Patients will be recruited from the John L. Trotter MS Center at Washington University in St. Louis. Participants will be referred to the study by their treating neurologist.
Key inclusion criteria (7 listed)
- Male or female, any race
- Age ≥ 18 years
- Capable of providing written informed consent for volunteering to undergo research procedures
- Diagnosis of MS as established by the referring physician and confirmed by the Sponsor-Investigator. Only patients with active disease, defined as at least 1 enhancing lesion present in the preceding 6 months, will be enrolled
- Treatment naïve except for relapse-related treatments such as corticosteroids or plasmapheresis,
Key exclusion criteria (11 listed)
- Presence of a low binding polymorphism for TSPO
- Hypersensitivity to [11C]-CS1P1, [11C]-DPA-713, [18F]-FDG, or any of their excipients
- Contraindications to PET, CT or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate
- eGFR less than 60 (for gadolinium)
- Severe claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotracer [11C]-CS1P1Radiotracer used in PET/CT scans of the head and neck Dose range: 12-17 mCi | Radiation | Participants |
| Radiotracer [11C]-DPA-713Radiotracer used in PET/CT scans of the head and neck Dose range:15-20 mCi | Radiation | Participants |
| anti-CD20 MS treatmentMS treatment taken indepenently after initial testing | Drug | Participants |
| Radiotracer [12F]-FDGused in PET/CT scans of the head and neck Dose: 5-7 mCi | Radiation | Participants |
Primary outcome
Volume of Distribution (Vt) of DPA-713 and CS1P1 and Cerebral metabolic rate of glucose (CMRglc) in white matter lesions and normal appearing white matter before and after treatment.
Time frame: 1 year
Changes in scRNAseq measures of inflammatory cell types in the CSF before and after treatment
Time frame: 1 year
1 secondary outcome
Correlation between changes in Vt or CMRglc compared to changes in cell type numbers from scRNAseq
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Results publication: PubMed 28002679Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
- Results publication: PubMed 32799417Maggi P, Sati P, Nair G, Cortese ICM, Jacobson S, Smith BR, Nath A, Ohayon J, van Pesch V, Perrotta G, Pot C, Theaudin M, Martinelli V, Scotti R, Wu T, Du Pasquier R, Calabresi PA, Filippi M, Reich DS, Absinta M. Paramagnetic Rim Lesions are Specific to Multiple Sclerosis: An International Multicenter 3T MRI Study. Ann Neurol. 2020 Nov;88(5):1034-1042. doi: 10.1002/ana.25877. Epub 2020 Sep 9.
- Results publication: PubMed 19617321Endres CJ, Pomper MG, James M, Uzuner O, Hammoud DA, Watkins CC, Reynolds A, Hilton J, Dannals RF, Kassiou M. Initial evaluation of 11C-DPA-713, a novel TSPO PET ligand, in humans. J Nucl Med. 2009 Aug;50(8):1276-82. doi: 10.2967/jnumed.109.062265. Epub 2009 Jul 17.
- Results publication: PubMed 35332093Brier MR, Hamdi M, Rajamanikam J, Zhao H, Mansor S, Jones LA, Rahmani F, Jindal S, Koudelis D, Perlmutter JS, Wong DF, Nickels M, Ippolito JE, Gropler RJ, Schindler TH, Laforest R, Tu Z, Benzinger TLS. Phase 1 Evaluation of 11C-CS1P1 to Assess Safety and Dosimetry in Human Participants. J Nucl Med. 2022 Nov;63(11):1775-1782. doi: 10.2967/jnumed.121.263189. Epub 2022 Mar 24.
- Results publication: PubMed 23007702Lassmann H, van Horssen J, Mahad D. Progressive multiple sclerosis: pathology and pathogenesis. Nat Rev Neurol. 2012 Nov 5;8(11):647-56. doi: 10.1038/nrneurol.2012.168. Epub 2012 Sep 25.
- Results publication: PubMed 35748669Hemond CC, Baek J, Ionete C, Reich DS. Paramagnetic rim lesions are associated with pathogenic CSF profiles and worse clinical status in multiple sclerosis: A retrospective cross-sectional study. Mult Scler. 2022 Nov;28(13):2046-2056. doi: 10.1177/13524585221102921. Epub 2022 Jun 24.
- Results publication: PubMed 25772897Mahad DH, Trapp BD, Lassmann H. Pathological mechanisms in progressive multiple sclerosis. Lancet Neurol. 2015 Feb;14(2):183-93. doi: 10.1016/S1474-4422(14)70256-X.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Brier, MD, PhD (314-362-7666, brierm@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Distribution (Vt) of DPA-713 and CS1P1 and Cerebral metabolic rate of glucose (CMRglc) in white matter lesions and normal appearing white matter before and after treatment. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591429, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.