Galantamine treatment for metabolic syndrome in people with spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the tolerability and potential benefit of galantamine extended-release in adults with chronic traumatic spinal cord injury and metabolic syndrome. Participants must have a cervical or paraplegic SCI, obesity by SCI-specific measures, and metabolic syndrome criteria, and they will receive galantamine hydrobromide extended release. The trial uses phased approaches (Phase 2 and Phase 3) to gather safety data and preliminary efficacy signals, with monitoring of inflammation and metabolic markers. Primary goals include tolerability and changes in metabolic and inflammatory biomarkers to inform future research. Locations include facilities in New Jersey and New York, led by Northwell Health with collaboration from several SCI-focused centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Northwell Health
  Manhasset, New York, United States Recruiting
• James J. Peters VA Medical Center
  The Bronx, New York, United States Recruiting
• Kessler Institute for Rehabilitation
  West Orange, New Jersey, United States Not yet recruiting

Study contacts

• Study coordinator: Ona Bloom, PhD
• Email: obloom@northwell.edu
• Phone: 516-562-1309

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.