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Идёт набор NCT06463743

Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)

Фаза II С лечением Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: metformin, Placebo.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 55 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS): Randomized, Placebo-controlled Pilot Study.

Обзор

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 mg/day) 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

Подробное описание

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.

Вмешательства

  • Препарат metformin
    metformin
  • Препарат Placebo
    Placebo

Первичные конечные точки

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [Срок оценки: 1 year]
  • Percent change in N-Acetyl Aspartate (NAA) in the cortex over 9 months [Срок оценки: 9 months]
Вторичные конечные точки (8)
  • Disability progression as measured with Expanded Disability Status Scale (EDSS) [Срок оценки: 1 year]
  • Symbol Digit Modality Test (SDMT) [Срок оценки: 1 year]
  • Brief Visuospatial Memory Test ( BVMT) [Срок оценки: 1 year]
  • California Verbal Learning Test (CVLT) [Срок оценки: 1 year]
  • Conventional MRI outcomes [Срок оценки: 9 months]
  • Timed 25-foot walk test (T25FWT) [Срок оценки: 1 year]
  • 9-hole peg test (9HPT) [Срок оценки: 1 year]
  • Myelin water fraction (MWF) [Срок оценки: 9 months]

Критерии участия

Критерии включения

  • age between 55 and 75 years old
  • having a diagnosis of MS based on the latest McDonald criteria
  • 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
  • EDSS score <7.0

Критерии исключения

  • inability to undergo MRI scans
  • inability to participate in the study during the study period
  • diabetes or uncontrolled cardiovascular disease
  • unable to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UBMD Neurolgy — Buffalo

Идентификаторы

NCT: NCT06463743 · STUDY00007603 · UL1TR001412

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗