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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
NOT_YET_RECRUITINGNorthwell Health
Manhasset, New York, United States
RECRUITINGJames J. Peters VA Medical Center
The Bronx, New York, United States
RECRUITINGChange 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).
Time frame: Visit 0 (Screening) through Visit 5 (Week 12)
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.
Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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.
Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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.
Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)
Heart rate (beats per minute) measured at each study visit and daily at home.
Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)
Change in Blood Pressure During Outpatient Treatment (Aim 2)
Blood pressure (mmHg) will be measured at each study visit and daily at home
Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)
Occurrence of Adverse Events During Outpatient Treatment (Aim 2)
Frequency and severity of all adverse events (AEs) during the 12-week outpatient dose escalation period, assessed at each study visit and via weekly phone calls. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by severity and relationship to study drug. The number of participants experiencing at least one AE will be reported.
Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Plasma Insulin
Fasting plasma insulin levels (µIU/mL) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Blood Glucose
Fasting blood glucose levels (mg/dL) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in HOMA-IR From Screening (Aim 2)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin (Unitless index ) at Visit 0 (Screening) and Visit 5 (Week 12)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in HbA1c From Screening
Hemoglobin A1c (HbA1c) levels (%) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in C-Reactive Protein (CRP)
C-reactive protein (CRP) levels (mg/L ) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Body Composition by DXA During Outpatient Treatment (Aim 2)
Total body fat mass (kg) and total body fat percentage measured by dual-energy X-ray absorptiometry (DXA) total body scan at Visit 2 (Day 2) and Visit 5 (Week 12)
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2)
Waist and Hip circumference (cm) measured by tape measure at Day 2 and at Week 12.
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2)
High frequency component of heart rate variability (HF-HRV), a valid estimate of cardio-vagal tone (ms²) measured during supine and seated observations Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
Time frame: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)