Metformin alone or added to other medicines for older adults with multiple sclerosis
Official title: Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS): Randomized, Placebo-controlled Pilot Study.
Run by State University of New York at Buffalo · NCT06463743 · Data updated 2026-11-12
This trial will test whether taking metformin (1500 mg extended release), alone or added to disease-modifying therapy, is safe and helps protect the brain in people aged 55–75 with stable multiple sclerosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | March 1, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06463743 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with MS aged 55–75 who have had no relapses or MRI disease activity for the past two years, an EDSS under 7.0, can undergo MRI, and do not have diabetes or uncontrolled cardiovascular disease.
✕Probably not a fit
People with diabetes, uncontrolled cardiovascular disease, recent relapses or MRI activity, inability to undergo MRI, or who cannot consent or attend visits are unlikely to be eligible or benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, placebo-controlled interventional trial gives participants metformin extended release (1500 mg/day) or placebo for a 9-month treatment period, either as monotherapy or added to their current disease-modifying therapy. The primary focus is on safety and gastrointestinal tolerability in an older MS population, with secondary measures of neuroprotection using MRI and magnetic resonance spectroscopy to track N-acetyl-aspartate (NAA) and other brain imaging markers. Eligible participants are aged 55–75, have a non-active MS course for at least two years, and an EDSS score below 7. The study is conducted at UBMD Neurology in Buffalo, NY, in collaboration with NCATS.
Why it matters
Potential benefit: If successful, metformin could offer a well-tolerated neuroprotective option that slows age- and MS-related brain tissue injury and supports neural repair in older people with MS.
How similar studies have gone: Preclinical studies suggest metformin may provide neuroprotection and support repair, but clinical evidence in people with MS—particularly older adults—is limited and this approach remains largely untested in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age between 55 and 75 years old 2. having a diagnosis of MS based on the latest McDonald criteria 3. non-active disease course (no relapses and no MRI activity) in the last 2 years as determined by the MS provider and based on the 2020 revised clinical course criteria 4. EDSS score \<7.0 Exclusion Criteria: 1. inability to undergo MRI scans 2. inability to participate in the study during the study period 3. diabetes or uncontrolled cardiovascular disease 4. unable to consent
Where it's running
-
UBMD Neurolgy
Buffalo, New York, United States Recruiting
Study contacts
- Study coordinator: Kara Patrick
- Email: kpatrick@buffalo.edu
- Phone: 7168295037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.