Identifying and Characterizing Preclinical MS (DREAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: biological samples

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Erin Longbrake, MD; Phone Number: 860-287-6100; Email: erin.longbrake@yale.edu

Study Locations

• United States
  • Connecticut
    • North Haven, Connecticut, United States, 06473
      • Recruiting
      • Yale University
      • Principal Investigator: Erin Longbrake, MD
      • Contact: Cynthia Marques; Phone Number: 203-287-6100; Email: cynthia.marques@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Currently pregnant
• Diagnosis of multiple sclerosis or any ongoing, systemic autoimmune disease
• Ongoing treatment with immunosuppressive medications

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ongoing prospective study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ongoing prospective study

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Roche-Genentech
• Investigators: Principal Investigator: Erin Longbrake, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): June 30, 2033

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: 2000032952

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No