Study of Galantamine to Treat Metabolic Syndrome in Adults With Chronic Traumatic Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the tolerability and preliminary efficacy of galantamine, a drug approved for Alzheimers disease, for treating metabolic syndrome in people with chronic traumatic spinal cord injury SCI. The study focuses on reducing inflammation linked to metabolic syndrome and includes adults aged 21 to 75 years with either tetraplegia or paraplegia who use wheelchairs for mobility. All participants will receive galantamine hydrobromide extended release capsules. Initially, a single 8mg dose is given orally in a lab with five hours of monitoring. Then, for 12 weeks, participants take 8mg daily for the first four weeks, followed by a possible increase to 16mg daily for the remaining eight weeks depending on tolerability. The two groups based on injury type are analyzed separately. Participants will be closely monitored through scheduled visits from screening through week 12. Assessments include heart rate and blood pressure during initial and outpatient phases, neurogenic bowel symptoms, inflammation markers, blood glucose and insulin measures, body composition scans, and waist and hip measurements. Adverse events and treatment tolerability are tracked throughout the study to evaluate safety and effects.

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