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RECRUITING
NCT07625332
PHASE2/PHASE3

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

Sponsor: Northwell Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06-15

Completion Date

2027-12

Last Updated

2026-06-04

Healthy Volunteers

No

Interventions

DRUG

Galantamine 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