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

28 maggio 2026 aggiornato da: Northwell Health

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • New Jersey
      • West Orange, New Jersey, Stati Uniti, 07052
        • Non ancora reclutamento
        • Kessler Institute for Rehabilitation
        • Sub-investigatore:
          • James Wilson, DO
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Chris Cirnigliaro, PhD
        • Investigatore principale:
          • Trevor Dyson-Hudson, MD
    • New York
      • Manhasset, New York, Stati Uniti, 11030
        • Reclutamento
        • Northwell Health
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Ona Bloom, PhD
        • Sub-investigatore:
          • Adam B Stein, MD
      • The Bronx, New York, Stati Uniti, 10468
        • Reclutamento
        • James J. Peters VA Medical Center
        • Investigatore principale:
          • Jill Wecht, EdD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Altri nomi:
  • Razadyne E.R

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Lasso di tempo: 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).
Visit 0 (Screening) through Visit 5 (Week 12)
Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)
Lasso di tempo: 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.
Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Blood Pressure During In-Lab Observation (Aim 1)
Lasso di tempo: 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.
Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Occurrence of Adverse Events During In-Lab Observation (Aim 1)
Lasso di tempo: 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.
Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)
Lasso di tempo: Visit 2 (Day 2) through Visit 5 (Week 12)
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)
Lasso di tempo: Visit 2 (Day 2) through Visit 5 (Week 12)
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)
Lasso di tempo: 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.
Visit 2 (Day 2) through Visit 5 (Week 12)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
Lasso di tempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 0 (Screening) and Visit 5 (Week 12)
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
Lasso di tempo: Visit 0 (Screening) and Visit 5 (Week 12)
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
Lasso di tempo: Visit 0 (Screening) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 0 (Screening) and Visit 5 (Week 12)
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
Lasso di tempo: Visit 0 (Screening) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 0 (Screening) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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)
Lasso di tempo: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Northwell Health

Collaboratori

Bronx Veterans Medical Research Foundation, Inc
Kessler Institute for Rehabilitation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-0846
  • C41213GM (Altro numero di sovvenzione/finanziamento: NYSCIRB NY State Department of Health)
  • 1349754 (Altro numero di sovvenzione/finanziamento: Craig H. Neilsen Foundation)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

All data must be de-identified in accordance with institutional, local, state, and federal guidelines.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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