Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Co… (NCT07625332) | Clinical Trial Compass
RecruitingPhase 2/3
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
United States60 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Res…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Timeframe: Visit 0 (Screening) through Visit 5 (Week 12)
2
Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)
Timeframe: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
3
Change in Blood Pressure During In-Lab Observation (Aim 1)
Timeframe: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
4
Occurrence of Adverse Events During In-Lab Observation (Aim 1)
Timeframe: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
5
Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)
Timeframe: Visit 2 (Day 2) through Visit 5 (Week 12)
6
Change in Blood Pressure During Outpatient Treatment (Aim 2)
Timeframe: Visit 2 (Day 2) through Visit 5 (Week 12)
7
Occurrence of Adverse Events During Outpatient Treatment (Aim 2)