Actively Recruiting
Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Led by Northwell Health · Updated on 2026-06-04
60
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
B
Bronx Veterans Medical Research Foundation, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the tolerability and preliminary efficacy of galantamine, a drug approved for Alzheimer's disease, for treating metabolic syndrome in people with chronic traumatic spinal cord injury (SCI). The study focuses on reducing inflammation linked to metabolic syndrome and includes adults aged 21 to 75 years with either tetraplegia or paraplegia who use wheelchairs for mobility. All participants will receive galantamine hydrobromide extended release capsules. Initially, a single 8mg dose is given orally in a lab with five hours of monitoring. Then, for 12 weeks, participants take 8mg daily for the first four weeks, followed by a possible increase to 16mg daily for the remaining eight weeks depending on tolerability. The two groups based on injury type are analyzed separately. Participants will be closely monitored through scheduled visits from screening through week 12. Assessments include heart rate and blood pressure during initial and outpatient phases, neurogenic bowel symptoms, inflammation markers, blood glucose and insulin measures, body composition scans, and waist and hip measurements. Adverse events and treatment tolerability are tracked throughout the study to evaluate safety and effects.
CONDITIONS
Brief Title
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21-75 years (male or female)
- Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury
- Wheelchair user for community mobility
- Injury level of tetraplegia (cervical) or paraplegia (all levels)
- SCI-specific obesity with waist circumference ≥94 cm
- Resting heart rate greater than 45 bpm based on 10 measurements over 10 minutes
- No clinically significant cardiovascular abnormalities on 12-lead ECG
- Tolerable bowel routine with ISCI-BDS score less than 10
- Metabolic syndrome with at least three of: obesity (waist ≥94 cm), fasting glucose ≥100 mg/dL, dyslipidemia (high triglycerides ≥150 mg/dL or low HDL cholesterol), or CRP >1 mg/dL
- Able to understand and communicate in English and complete outcome measures
- Willing to comply with study procedures and available for study duration
- Signed informed consent provided
You will not qualify if you...
- Neurological injury or condition other than spinal cord injury
- Progressive condition expected to change neurological status
- Signs or symptoms of cardiovascular disease or arrhythmias
- Resting heart rate less than 45 bpm
- ISCI-BDS score of 10 or higher indicating moderate to severe bowel dysfunction
- Severe concurrent medical disease or condition contraindicated by physician
- Documented psychopathology that may conflict with study objectives
- Pregnancy, nursing, or planning pregnancy during the study
- Active cancer or currently undergoing cancer treatment
- Triglyceride levels ≥400 mg/dL
- Chronic use of medications interacting with galantamine
- Enrolled in another research study that may interfere with this study
- Any other contraindications as determined by the site physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive galantamine hydrobromide extended release capsules starting with a single 8mg dose in the laboratory with 5 hours of observation, followed by daily oral doses for 12 weeks with a possible dose escalation from 8mg to 16mg based on tolerability.
5 visits including Day 1 (in-lab observation), Day 2, Week 4, Week 8, and Week 12 (outpatient visits)
Trial Site Locations
Total: 3 locations
1
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
Not Yet Recruiting
2
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
3
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
Research Team
O
Ona Bloom, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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