Northwell Health
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.
Inclusion Criteria: * 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)…
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.
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