NCT05787795

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
87mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jun 2022Jun 2033

Study Start

First participant enrolled

June 21, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2032

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2033

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

10 years

First QC Date

March 15, 2023

Last Update Submit

November 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Individual data types collected

    ongoing prospective study

Interventions

blood draw, oral swab, optional stool samples, spinal fluid sample, fat biopsy, tonsil biopsy, lymph node tissue sample, MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

North Haven, Connecticut, 06473, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and gingival swabs

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Erin Longbrake, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Longbrake, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

June 21, 2022

Primary Completion (Estimated)

June 30, 2032

Study Completion (Estimated)

June 30, 2033

Last Updated

November 14, 2025

Record last verified: 2025-11

Locations