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

NCT07625332 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 25-0846C41213GM1349754
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Paraplegia and Tetraplegia; Metabolic Syndrome; Traumatic Spinal Cord Injury; Spinal Cord Injury

Keywords

spinal cord injury; tetraplegia; paraplegia; metabolic syndrome

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (12)

• Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)

  Visit 2 (Day 2) and Visit 5 (Week 12)

• Change in Plasma Leptin During Outpatient Treatment (Aim 2)

  Visit 2 (Day 2) and Visit 5 (Week 12)

• Change in Plasma Adiponectin During Outpatient Treatment (Aim 2)

  Visit 2 (Day 2) and Visit 5 (Week 12)

• Change in Lipids (HDL, LDL, and Triglycerides)

  Visit 0 (Screening) and Visit 5 (Week 12)

• Change in Fasting Plasma Insulin

  Visit 0 (Screening) and Visit 5 (Week 12)

Study Arms (1)

Galantamine ER

EXPERIMENTAL

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

Interventions

Galantamine Hydrobromide Extended Release DRUG

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.

Also known as: Razadyne ER

Galantamine ER

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Kessler Institute for Rehabilitation: collaborator
• Bronx Veterans Medical Research Foundation, Inc: collaborator

Study Sites (3)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

NOT YET RECRUITING

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia; Metabolic Syndrome

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ona Bloom, PhD

CONTACT

516-562-1309; obloom@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an exploratory, three-site, parallel group, open-label study to evaluate tolerability and preliminary efficacy of galantamine to treat MetS via reduction of systemic inflammation in people with chronic SCI (tetraplegia or paraplegia). Participants with tetraplegia or paraplegia will be analyzed separately as independent groups.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 4, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

US (3)