Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT05787795

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

biological samples

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT05787795

Start date

Jun 21, 2022

Status verified date

Aug, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jun 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

biological samples

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

Primary outcome measure

  • To build a machine learning model of risk prediction [ Time Frame: ongoing prospective study ]

Central Contacts and Locations

Central contacts

Erin Longbrake, MD

860-287-6100erin.longbrake@yale.edu

Locations

Yale University

Recruiting

North Haven, Connecticut, United States, 06473

Contacts

Cynthia Marques

203-287-6100cynthia.marques@yale.edu

Principal Investigator:

Erin Longbrake, MD

More Information

Sponsor

Yale University

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-27.