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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-75
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Galantamine Hydrobromide Extended Release

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Northwell Health

Lead sponsor

Bronx Veterans Medical Research Foundation, Inc

Collaborator

Kessler Institute for Rehabilitation

Collaborator