Metformin alone or added to other medicines for older adults with multiple sclerosis
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS): Randomized, Placebo-controlled Pilot Study.
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 |
| Enrollment | 30 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06463743 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Buffalo, New York
- UBMD Neurolgy — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Kara Patrick
- Email: kpatrick@buffalo.edu
- Phone: 7168295037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.