Recruiting
Phase 2
Phase 3

Galantamine

Sponsor:

Northwell Health

Code:

NCT07625332

Conditions

Spinal Cord Injury

Traumatic Spinal Cord Injury

Paraplegia and Tetraplegia

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Galantamine Hydrobromide Extended Release

Study Details

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

Spinal Cord Injury

Traumatic Spinal Cord Injury

Paraplegia and Tetraplegia

Metabolic Syndrome

Study ID

NCT07625332

Start date

Jun 15, 2026

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2) [ Time Frame: Visit 0 (Screening) through Visit 5 (Week 12) ]
  • Change in Heart Rate (Avg) During In-Lab Observation (Aim 1) [ Time Frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose) ]
  • Change in Blood Pressure During In-Lab Observation (Aim 1) [ Time Frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose) ]
  • Occurrence of Adverse Events During In-Lab Observation (Aim 1) [ Time Frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose) ]
  • Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2) [ Time Frame: Visit 2 (Day 2) through Visit 5 (Week 12) ]
  • Change in Blood Pressure During Outpatient Treatment (Aim 2) [ Time Frame: Visit 2 (Day 2) through Visit 5 (Week 12) ]
  • Occurrence of Adverse Events During Outpatient Treatment (Aim 2) [ Time Frame: Visit 2 (Day 2) through Visit 5 (Week 12) ]

Central Contacts and Locations

Central contacts

Ona Bloom, PhD

516-562-1309obloom@northwell.edu

Locations

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Welmi Pello, MPH, RN

516-562-1331wpello@northwell.edu

Joy Cambe, MD, MPH

516-562-1331jcambe@northwell.edu

Principal Investigator:

Ona Bloom, PhD

James J. Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Dylan Arnero, MA

718-584-9000Dylan.Arnero@va.gov

Genevieve Curtis

718-584-9000Genevieve.Curtis@va.gov

Principal Investigator:

Jill Wecht, EdD

More Information

Sponsor

Northwell Health

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

  • spinal cord injury
  • tetraplegia
  • paraplegia
  • metabolic syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-04.