NCT07625332招募中2 期
Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
研究点 (3)
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