Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463743
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-22
Brief Title:
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis MS
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis MS Randomized Placebo-controlled Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to learn about treating older people with multiple sclerosis MS with metformin Metformin may be used as a single therapy or as an add-on therapy The investigators want to learn
The safety and tolerability of metformin extended release 1500 mgday as a single therapy or as an add-on therapy in older people with MS compared to placebo
How well metformin protects the nervous system against injury compared with placebo measured by brain MRI over a 9 month treatment period
The effect of metformin to protect brain tissue from age and MS related injury when compared to the placebo group over a 9 month treatment period
The safety and tolerability of metformin extended release 1500 mgday as a single therapy or as an add-on therapy in older people with MS compared to placebo
How well metformin protects the nervous system against injury compared with placebo measured by brain MRI over a 9 month treatment period
The effect of metformin to protect brain tissue from age and MS related injury when compared to the placebo group over a 9 month treatment period
Detailed Description:
Specific aims and rationale
The main aim of this study is to determine the safety of metformin as monotherapy or as an add-on therapy to the disease modifying treatment in aging people with multiple sclerosis pwMS While the tolerability of metformin has been studies in the general population data specific to the MS population is not currently available Moreover understanding the gastrointestinal tolerability of metformin when added on MS disease modifying treatment is needed Secondly the study aims at understating the potential neuroprotective properties of metformin as measured through magnetic resonance spectroscopy and change in N-acetyl-aspartate NAA levels over a 9-month study period This pilot study will provide valuable insights into the efficacy and safety of add-on or monotherapy metformin therapy as a potential therapeutic approach to address the complex pathophysiology of MS and offer new avenues for promoting neuroprotection along with potential support for neural repair and remyelination in individuals with this debilitating condition Previous pre-clinical studies have shown that metformin can promote neuroprotection by reducing oxidative stress and inflammation and is able to enhance the reparative mechanisms within the central nervous system CNS Currently there are no neuroprotective interventions available for pwMS that directly target the neurodegenerative component of MS with particular emphasis for the aging MS population The investigators hypothesize that older pwMS that are treated with metformin will have a significantly lower decline in N-acetylaspartate levels when compared to pwMS not treated with metformin
The main aim of this study is to determine the safety of metformin as monotherapy or as an add-on therapy to the disease modifying treatment in aging people with multiple sclerosis pwMS While the tolerability of metformin has been studies in the general population data specific to the MS population is not currently available Moreover understanding the gastrointestinal tolerability of metformin when added on MS disease modifying treatment is needed Secondly the study aims at understating the potential neuroprotective properties of metformin as measured through magnetic resonance spectroscopy and change in N-acetyl-aspartate NAA levels over a 9-month study period This pilot study will provide valuable insights into the efficacy and safety of add-on or monotherapy metformin therapy as a potential therapeutic approach to address the complex pathophysiology of MS and offer new avenues for promoting neuroprotection along with potential support for neural repair and remyelination in individuals with this debilitating condition Previous pre-clinical studies have shown that metformin can promote neuroprotection by reducing oxidative stress and inflammation and is able to enhance the reparative mechanisms within the central nervous system CNS Currently there are no neuroprotective interventions available for pwMS that directly target the neurodegenerative component of MS with particular emphasis for the aging MS population The investigators hypothesize that older pwMS that are treated with metformin will have a significantly lower decline in N-acetylaspartate levels when compared to pwMS not treated with metformin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None