NCT07625332 · Northwell Health
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
What this study is about
The purpose of this research study is to measure the tolerability and preliminary effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Galantamine Hydrobromide Extended Release
Galantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks.
Primary outcome measures
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- West Orange, New Jersey
- Manhasset, New York
- The Bronx, New York
Collaborators
Bronx Veterans Medical Research Foundation, Inc, Kessler Institute for Rehabilitation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations