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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Spinal Cord Injury; Traumatic Spinal Cord Injury; Paraplegia and Tetraplegia
• Intervention / Treatment: Drug: Galantamine Hydrobromide Extended Release

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ona Bloom, PhD; Phone Number: 516-562-1309; Email: obloom@northwell.edu

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Not yet recruiting
      • Kessler Institute for Rehabilitation
      • Sub-Investigator: James Wilson, DO
      • Contact: Trevor Dyson-Hudson, MD; Phone Number: 917-838-3143; Email: tdysonhudson@kesslerfoundation.org
      • Contact: Matthew Maher, MS; Phone Number: 1706 718-584-9000; Email: Matthew.Maher@va.gov
      • Sub-Investigator: Chris Cirnigliaro, PhD
      • Principal Investigator: Trevor Dyson-Hudson, MD
  • New York
    • Manhasset, New York, United States, 11030
      • Recruiting
      • Northwell Health
      • Contact: Joy Cambe, MD, MPH; Phone Number: 516-562-1331; Email: jcambe@northwell.edu
      • Contact: Welmi Pello, MPH, RN; Phone Number: 516-562-1331; Email: wpello@northwell.edu
      • Principal Investigator: Ona Bloom, PhD
      • Sub-Investigator: Adam B Stein, MD
    • The Bronx, New York, United States, 10468
      • Recruiting
      • James J. Peters VA Medical Center
      • Principal Investigator: Jill Wecht, EdD
      • Contact: Dylan Arnero, MA; Phone Number: 3128 718-584-9000; Email: Dylan.Arnero@va.gov
      • Contact: Genevieve Curtis; Phone Number: 3123 718-584-9000; Email: Genevieve.Curtis@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Galantamine ER; All participants (tetraplegia and paraplegia cohorts) receive galantamine hydrobromide extended release (ER) capsules. Aim 1 (Day 1): single 8mg dose administered orally in the laboratory with at least 5 hours of monitored observation. Aim 2 (Weeks 1-12): 8mg once daily for Weeks 1-4, with dose escalation to 16mg (two 8mg capsules) once daily for Weeks 5-12 based on tolerability. Taken orally in the morning with a meal. The two cohorts (tetraplegia and paraplegia) are analyzed separately as pre-specified subgroups.

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.; Other Names: Razadyne ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)	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).	Visit 0 (Screening) through Visit 5 (Week 12)
Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)	Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.	Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Blood Pressure During In-Lab Observation (Aim 1)	Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.	Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Occurrence of Adverse Events During In-Lab Observation (Aim 1)	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.	Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)	Heart rate (beats per minute) measured at each study visit and daily at home.	Visit 2 (Day 2) through Visit 5 (Week 12)
Change in Blood Pressure During Outpatient Treatment (Aim 2)	Blood pressure (mmHg) will be measured at each study visit and daily at home	Visit 2 (Day 2) through Visit 5 (Week 12)
Occurrence of Adverse Events During Outpatient Treatment (Aim 2)	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.	Visit 2 (Day 2) through Visit 5 (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)	Inflammatory markers such as: TNF-α, IL-1ß, IL-6, IL-10, and other cytokines (pg/ml) will be measured in plasma at Visit 2 (Day 2) and Visit 5 (Week 12)	Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Leptin During Outpatient Treatment (Aim 2)	Plasma leptin levels measured (pg/ml) at Visit 2 (Day 2) and Visit 5 (Week 12)	Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Adiponectin During Outpatient Treatment (Aim 2)	Plasma adiponectin levels (µg/mL) measured at Visit 2 (Day 2) and Visit 5 (Week 12)	Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Lipids (HDL, LDL, and Triglycerides)	High-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides (mg/dL) will be measured at Visit 0 (Screening) and Visit 5 (Week 12)	Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Plasma Insulin	Fasting plasma insulin levels (µIU/mL) measured at Visit 0 (Screening) and Visit 5 (Week 12)	Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Blood Glucose	Fasting blood glucose levels (mg/dL) measured at Visit 0 (Screening) and Visit 5 (Week 12)	Visit 0 (Screening) and Visit 5 (Week 12)
Change in HOMA-IR From Screening (Aim 2)	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin (Unitless index ) at Visit 0 (Screening) and Visit 5 (Week 12)	Visit 0 (Screening) and Visit 5 (Week 12)
Change in HbA1c From Screening	Hemoglobin A1c (HbA1c) levels (%) measured at Visit 0 (Screening) and Visit 5 (Week 12)	Visit 0 (Screening) and Visit 5 (Week 12)
Change in C-Reactive Protein (CRP)	C-reactive protein (CRP) levels (mg/L ) measured at Visit 0 (Screening) and Visit 5 (Week 12)	Visit 0 (Screening) and Visit 5 (Week 12)
Change in Body Composition by DXA During Outpatient Treatment (Aim 2)	Total body fat mass (kg) and total body fat percentage measured by dual-energy X-ray absorptiometry (DXA) total body scan at Visit 2 (Day 2) and Visit 5 (Week 12)	Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2)	Waist and Hip circumference (cm) measured by tape measure at Day 2 and at Week 12.	Visit 2 (Day 2) and Visit 5 (Week 12)
Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2)	High frequency component of heart rate variability (HF-HRV), a valid estimate of cardio-vagal tone (ms²) measured during supine and seated observations Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)	Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Bronx Veterans Medical Research Foundation, Inc; Kessler Institute for Rehabilitation

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: metabolic syndrome; spinal cord injury; tetraplegia; paraplegia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Metabolic Syndrome; Spinal Cord Injuries; Quadriplegia; Paraplegia; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Benzazepines; Amaryllidaceae Alkaloids; Galantamine
• Other Study ID Numbers: 25-0846; C41213GM (Other Grant/Funding Number: NYSCIRB NY State Department of Health); 1349754 (Other Grant/Funding Number: Craig H. Neilsen Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All data must be de-identified in accordance with institutional, local, state, and federal guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes