RecruitingPhase 2Phase 3NCT07625332

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

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


Sponsor

Northwell Health

Enrollment

60 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 21 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Galantamine Hydrobromide Extended Release for people with metabolic syndrome, paraplegia and tetraplegia, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 21 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGalantamine Hydrobromide Extended Release

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.


Locations(3)

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Northwell Health

Manhasset, New York, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

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NCT07625332


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