Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Recruiting now · Phase 2/Phase 3
Conditions studied: Spinal Cord Injury, Traumatic Spinal Cord Injury, Paraplegia and Tetraplegia, Metabolic Syndrome
In brief
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.
Key facts
- Study ID
- NCT07625332
- Run by
- Northwell Health
- People needed
- 60
- Starts
- 2026-06-15
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- SCI-specific obesity indicated by waist circumference ≥94 cm
- Resting heart rate >45 bpm based on 10 measurements over 10 minutes
- Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG
- Tolerable bowel routine indicated by a score of <10 on the International SCI Bowel Function Data Set (ISCI-BDS)
- Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg/dL, (3) dyslipidemia: high triglycerides ≥150 mg/dL or low HDL cholesterol <40 mg/dL for men and <50 mg/dL for women, (4) C-reactive protein (CRP) levels >1 mg/dL
- Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures
- Willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
You may not qualify if…
- 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
- Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
- Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician
- Psychopathology documented in the medical record or history that may conflict with study objectives
- Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study
- Active cancer or currently in treatment for cancer
- Triglyceride levels ≥400 mg/dL
- Chronic use of medications with known or probable interactions with galantamine
- Enrolled in another research study that is likely to interfere with conduct or results of the current study
- Any other reason the site physician feels that participation is contraindicated
Where it is running
- Northwell Health — Manhasset, New York, United States (enrolling)
- James J. Peters VA Medical Center — The Bronx, New York, United States (enrolling)
- Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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