Multiple SclerosisDREAMNCT05787795
Identifying and Characterizing Preclinical MS
An observational study of Multiple Sclerosis, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- biological samples
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 30 Jun 2033
- How long will I take part?
- 5 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with risk factors for MS (based on personal demographics, past medical history, or family history) will be recruited to provide clinical information and biospecimens serially over time.
Who may be able to join
- Age 18+
- Having one or more risk factors for multiple sclerosis, including one or more of the below:
- Individuals known to have a radiologically isolated syndrome
- Individuals with a family history of multiple sclerosis (first degree family member)
- Individuals with personal risk factors, which are known to include smoking, obesity, Epstein Barr virus infections, Vitamin D deficiency, genetic risk score
Who cannot join
- Currently pregnant
- Diagnosis of multiple sclerosis or any ongoing, systemic autoimmune disease
- Ongoing treatment with immunosuppressive medications
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
Yale University
North Haven, Connecticut, 06473
Cynthia Marques, 203-287-6100, cynthia.marques@yale.edu
Erin Longbrake, MD
About this study
The purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.
Read the detailed description
The purpose of this study is to try and learn how to identify multiple sclerosis (MS) before it causes any neurologic symptoms. By the time MS causes symptoms, the disease has often been causing damage under the surface for years. Because early treatment of MS helps prevent long term disability from the disease, the investigators are hypothesizing that if MS could be detected (and treated) before symptoms start, the disease might be preventable.
The investigators believe that people who go on to develop MS have changes in their immune systems long before they have symptoms. Some of these changes might be in "hidden" parts of the body, like lymph nodes or fat tissue. The investigators want to study people who have risk factors for MS to try and learn to detect very early signs of disease.
Study procedures will include:
All study participants will undergo a blood draw and an oral swab; they will also complete baseline questionnaires All study participants will be contacted approximately once per year and asked to complete some additional questionnaires All study participants may be asked to donate repeat blood/oral swab specimens or stool specimens over time on an ad hoc basis Study participants who agree will undergo additional optional procedures to study the immune system in different parts of the body.
The optional procedures include:
Lumbar punctures (to obtain spinal fluid) Tonsil biopsy Fat biopsy (to obtain fat cells) Lymph node biopsy (to obtain lymph node tissues with immune cells) Traditional brain MRI Low-field (portable) brain MRI
One in-person visit is required. There will also be annual phone/email contact, which may take up to 30 minutes The required in-person visit will take approximately 1 hour total. Anyone who agrees to donate follow up biospecimens, undergo a procedure, or undergo an MRI will have additional in-person visits Optional visits for donating biospecimens, having a procedure or getting an MRI may take longer (up to 3 hours), depending on what is happening during the visit.
- Conditions
- Multiple Sclerosis
- Being tested
- biological samples
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplesOther
blood draw, oral swab, optional stool samples, spinal fluid sample, fat biopsy, tonsil biopsy, lymph node tissue sample, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
To build a machine learning model of risk prediction
to build a risk prediction model that estimates future risk of MS built using large datasets of biologic and clinical data collected during the study.
Measured: ongoing prospective study
Secondary outcomes (1)
Individual data types collected
Microbiome data, immune phenotyping and functional analysis for blood, CSF, adipose tissue, measurement of other known and developing biomarkers of MS, patient reported health outcomes will be compiled to potentially identify early, systemic changes that are associated with a future risk of multiple sclerosis.
Measured: ongoing prospective study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start21 Jun 2022
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
- Investigators
- Erin Longbrake, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787795
- Sponsor's protocol ID
- 2000032952
- Acronym
- DREAM
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Characterizing Preclinical MS
- ClinicalTrials.gov ID
- NCT05787795
- Acronym / sponsor ID
- DREAM / 2000032952
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Roche-Genentech
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Jun 2032 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 28 Mar 2023 (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 purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.
Detailed description
The purpose of this study is to try and learn how to identify multiple sclerosis (MS) before it causes any neurologic symptoms. By the time MS causes symptoms, the disease has often been causing damage under the surface for years. Because early treatment of MS helps prevent long term disability from the disease, the investigators are hypothesizing that if MS could be detected (and treated) before symptoms start, the disease might be preventable.
The investigators believe that people who go on to develop MS have changes in their immune systems long before they have symptoms. Some of these changes might be in "hidden" parts of the body, like lymph nodes or fat tissue. The investigators want to study people who have risk factors for MS to try and learn to detect very early signs of disease.
Study procedures will include:
All study participants will undergo a blood draw and an oral swab; they will also complete baseline questionnaires All study participants will be contacted approximately once per year and asked to complete some additional questionnaires All study participants may be asked to donate repeat blood/oral swab specimens or stool specimens over time on an ad hoc basis Study participants who agree will undergo additional optional procedures to study the immune system in different parts of the body.
The optional procedures include:
Lumbar punctures (to obtain spinal fluid) Tonsil biopsy Fat biopsy (to obtain fat cells) Lymph node biopsy (to obtain lymph node tissues with immune cells) Traditional brain MRI Low-field (portable) brain MRI
One in-person visit is required. There will also be annual phone/email contact, which may take up to 30 minutes The required in-person visit will take approximately 1 hour total. Anyone who agrees to donate follow up biospecimens, undergo a procedure, or undergo an MRI will have additional in-person visits Optional visits for donating biospecimens, having a procedure or getting an MRI may take longer (up to 3 hours), depending on what is happening during the visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with risk factors for MS (based on personal demographics, past medical history, or family history) will be recruited to provide clinical information and biospecimens serially over time.
Key inclusion criteria (5 listed)
- Age 18+
- Having one or more risk factors for multiple sclerosis, including one or more of the below:
Key exclusion criteria (3 listed)
- Currently pregnant
- Diagnosis of multiple sclerosis or any ongoing, systemic autoimmune disease
- Ongoing treatment with immunosuppressive medications
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 |
|---|---|---|
| biological samplesblood draw, oral swab, optional stool samples, spinal fluid sample, fat biopsy, tonsil biopsy, lymph node tissue sample, MRI | Other | – |
Primary outcome
To build a machine learning model of risk prediction
Time frame: ongoing prospective study
to build a risk prediction model that estimates future risk of MS built using large datasets of biologic and clinical data collected during the study.
1 secondary outcome
Individual data types collected
Time frame: ongoing prospective study
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 27 Aug 2026.
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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.
Erin Longbrake, MD principal investigator
Yale University
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 Yale University 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 5 inclusion and 3 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 27 Aug 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 Erin Longbrake, MD (860-287-6100, erin.longbrake@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To build a machine learning model of risk prediction (time frame: ongoing prospective study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.