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Pilot Study of Galantamine for Metabolic Syndrome in Spinal Cord Injury

This research study is testing a drug called galantamine hydrobromide extended release to see if it can help treat metabolic syndrome (a group of conditions that increase your risk of heart disease, stroke, and diabetes) in people with chronic traumatic spinal cord injury (SCI). Galantamine is approved for Alzheimer's disease, but it's considered experimental for this study. Researchers want to see if it's safe and effective at reducing inflammation. You might be able to join if you are 21-75 years old, have had a spinal cord injury for at least a year, use a wheelchair, and meet specific criteria for obesity and heart rate. The study will look at changes in bowel symptoms, heart rate, and blood pressure over 12 weeks.

Study design
This is an interventional study with a planned enrollment of 60 participants. It is testing galantamine hydrobromide extended release at different doses.
What's involved
You would take galantamine once daily for at least 12 weeks, with observations in the lab for at least 5 hours on day one.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured from screening through Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07625332

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

Recruiting
PHASE2Ages 21–75InterventionalTreatment
Northwell Health
~60 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Galantamine Hydrobromide Extended Release

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Measured over Visit 0 (Screening) through Visit 5 (Week 12)
+6 more outcomes measured

Conditions

Spinal Cord Injury
Traumatic Spinal Cord Injury
Paraplegia and Tetraplegia
Metabolic Syndrome

Explore related trials

Metabolic SyndromeTraumatic spinal cord injuryC-Reactive Protein

Where it's being run

3 sites across 2 states
New York2
New Jersey1

Who to contact

Ona Bloom, PhD
[email protected]
516-562-1309
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)Visit 0 (Screening) through Visit 5 (Week 12)

    Neurogenic bowel symptoms assessed using the International SCI Bowel Function Data Set (ISCI-BDS). Worsening will be defined as a negative change in ISCI-BDS score category (e.g., mild to moderate).

  • Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)Visit 1 (Day 1; pre-dose through 5 hours post-dose)

    Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.

  • Change in Blood Pressure During In-Lab Observation (Aim 1)Visit 1 (Day 1; pre-dose through 5 hours post-dose)

    Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.

  • Occurrence of Adverse Events During In-Lab Observation (Aim 1)Visit 1 (Day 1; pre-dose through 5 hours post-dose)

    Frequency and severity of all adverse events (AEs) during the in-lab observation period after a single dose of galantamine 8mgER, assessed by standardized AE survey and open-ended questions. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants experiencing at least one AE will be reported.

  • Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)Visit 2 (Day 2) through Visit 5 (Week 12)

    Heart rate (beats per minute) measured at each study visit and daily at home.

  • Change in Blood Pressure During Outpatient Treatment (Aim 2)Visit 2 (Day 2) through Visit 5 (Week 12)

    Blood pressure (mmHg) will be measured at each study visit and daily at home

  • Occurrence of Adverse Events During Outpatient Treatment (Aim 2)Visit 2 (Day 2) through Visit 5 (Week 12)

    Frequency and severity of all adverse events (AEs) during the 12-week outpatient dose escalation period, assessed at each study visit and via weekly phone calls. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by severity and relationship to study drug. The number of participants experiencing at least one AE will be reported.