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.
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)
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
Single group
Galantamine Hydrobromide Extended Release
DrugGalantamine 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.
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Neurogenic bowel symptoms assessed using the International SCI Bowel Function Data Set (ISCI-BDS). Worsening will be defined as a negative change in ISCI-BDS score category (e.g., mild to moderate).
Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)
Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
Change in Blood Pressure During In-Lab Observation (Aim 1)
Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
Occurrence of Adverse Events During In-Lab Observation (Aim 1)
Frequency and severity of all adverse events (AEs) during the in-lab observation period after a single dose of galantamine 8mgER, assessed by standardized AE survey and open-ended questions. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants experiencing at least one AE will be reported.
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
Inflammatory markers such as: TNF-α, IL-1ß, IL-6, IL-10, and other cytokines (pg/ml) will be measured in plasma at Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Leptin During Outpatient Treatment (Aim 2)
Plasma leptin levels measured (pg/ml) at Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Adiponectin During Outpatient Treatment (Aim 2)
Plasma adiponectin levels (µg/mL) measured at Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Lipids (HDL, LDL, and Triglycerides)
High-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides (mg/dL) will be measured at Visit 0 (Screening) and Visit 5 (Week 12)
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Northwell Health
Lead sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborator
Kessler Institute for Rehabilitation
Collaborator
