NCT07625332 Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
| NCT ID | NCT07625332 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Northwell Health |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-06-15 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07625332 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07625332 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07625332 currently recruiting?
Yes, NCT07625332 is actively recruiting participants. Contact the research team at obloom@northwell.edu for enrollment information.
Where is the NCT07625332 trial being conducted?
This trial is being conducted at West Orange, United States, Manhasset, United States, The Bronx, United States.
Who is sponsoring the NCT07625332 clinical trial?
NCT07625332 is sponsored by Northwell Health. The trial plans to enroll 60 participants.