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

Northwell Health

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: Galantamine Hydrobromide Extended Release

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07625332

C41213GM (Other Grant/Funding Number)

1349754 (Other Grant/Funding Number)

25-0846

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Galantamine ER

Experimental group

Description:

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.

Treatment:

Drug: Galantamine Hydrobromide Extended Release