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Идёт набор NCT07625332

Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)

Фаза II / Фаза III С лечением Spinal Cord Injury Traumatic Spinal Cord Injury Paraplegia and Tetraplegia Metabolic Syndrome

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: Galantamine Hydrobromide Extended Release.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury, Traumatic Spinal Cord Injury, Paraplegia and Tetraplegia, Metabolic Syndrome. Базовые параметры: 21 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

Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)

Обзор

The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.

Вмешательства

  • Препарат Galantamine Hydrobromide Extended Release
    Galantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks.

Первичные конечные точки

  • Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2) [Срок оценки: Visit 0 (Screening) through Visit 5 (Week 12)]
  • Change in Heart Rate (Avg) During In-Lab Observation (Aim 1) [Срок оценки: Visit 1 (Day 1; pre-dose through 5 hours post-dose)]
  • Change in Blood Pressure During In-Lab Observation (Aim 1) [Срок оценки: Visit 1 (Day 1; pre-dose through 5 hours post-dose)]
  • Occurrence of Adverse Events During In-Lab Observation (Aim 1) [Срок оценки: Visit 1 (Day 1; pre-dose through 5 hours post-dose)]
  • Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) through Visit 5 (Week 12)]
  • Change in Blood Pressure During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) through Visit 5 (Week 12)]
  • Occurrence of Adverse Events During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) through Visit 5 (Week 12)]
Вторичные конечные точки (12)
  • Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Plasma Leptin During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Plasma Adiponectin During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Lipids (HDL, LDL, and Triglycerides) [Срок оценки: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in Fasting Plasma Insulin [Срок оценки: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in Fasting Blood Glucose [Срок оценки: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in HOMA-IR From Screening (Aim 2) [Срок оценки: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in HbA1c From Screening [Срок оценки: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in C-Reactive Protein (CRP) [Срок оценки: Visit 0 (Screening) and Visit 5 (Week 12)]
  • Change in Body Composition by DXA During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2) and Visit 5 (Week 12)]
  • Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2) [Срок оценки: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)]

Критерии участия

Критерии включения

  • Adults aged 21-75 years (male or female)
  • Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)
  • Wheelchair user for community mobility
  • Injury level of tetraplegia (cervical level) or paraplegia (all levels)
  • SCI-specific obesity indicated by waist circumference ≥94 cm
  • Resting heart rate >45 bpm based on 10 measurements over 10 minutes
  • Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG
  • Tolerable bowel routine indicated by a score of <10 on the International SCI Bowel Function Data Set (ISCI-BDS)
  • Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg/dL, (3) dyslipidemia: high triglycerides ≥150 mg/dL or low HDL cholesterol <40 mg/dL for men and <50 mg/dL for women, (4) C-reactive protein (CRP) levels >1 mg/dL
  • Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures
  • Willingness to comply with all study procedures and availability for the duration of the study
  • Provision of signed and dated informed consent form

Критерии исключения

  • Diagnosis of neurological injury or condition other than SCI
  • Progressive condition that would be expected to change neurological status
  • Signs and symptoms of cardiovascular disease or cardiac arrhythmias
  • Resting heart rate <45 bpm
  • Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
  • Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician
  • Psychopathology documented in the medical record or history that may conflict with study objectives
  • Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study
  • Active cancer or currently in treatment for cancer
  • Triglyceride levels ≥400 mg/dL
  • Chronic use of medications with known or probable interactions with galantamine
  • Enrolled in another research study that is likely to interfere with conduct or results of the current study
  • Any other reason the site physician feels that participation is contraindicated

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • Kessler Institute for Rehabilitation — West Orange
  • Northwell Health — Manhasset
  • James J. Peters VA Medical Center — The Bronx

Идентификаторы

NCT: NCT07625332 · 25-0846 · C41213GM · 1349754

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗