Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
28 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ona Bloom, PhD
- Número de teléfono: 516-562-1309
- Correo electrónico: obloom@northwell.edu
Ubicaciones de estudio
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New Jersey
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West Orange, New Jersey, Estados Unidos, 07052
- Aún no reclutando
- Kessler Institute for Rehabilitation
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Sub-Investigador:
- James Wilson, DO
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Contacto:
- Trevor Dyson-Hudson, MD
- Número de teléfono: 917-838-3143
- Correo electrónico: tdysonhudson@kesslerfoundation.org
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Contacto:
- Matthew Maher, MS
- Número de teléfono: 1706 718-584-9000
- Correo electrónico: Matthew.Maher@va.gov
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Sub-Investigador:
- Chris Cirnigliaro, PhD
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Investigador principal:
- Trevor Dyson-Hudson, MD
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New York
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Manhasset, New York, Estados Unidos, 11030
- Reclutamiento
- Northwell Health
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Contacto:
- Joy Cambe, MD, MPH
- Número de teléfono: 516-562-1331
- Correo electrónico: jcambe@northwell.edu
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Contacto:
- Welmi Pello, MPH, RN
- Número de teléfono: 516-562-1331
- Correo electrónico: wpello@northwell.edu
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Investigador principal:
- Ona Bloom, PhD
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Sub-Investigador:
- Adam B Stein, MD
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The Bronx, New York, Estados Unidos, 10468
- Reclutamiento
- James J. Peters VA Medical Center
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Investigador principal:
- Jill Wecht, EdD
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Contacto:
- Dylan Arnero, MA
- Número de teléfono: 3128 718-584-9000
- Correo electrónico: Dylan.Arnero@va.gov
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Contacto:
- Genevieve Curtis
- Número de teléfono: 3123 718-584-9000
- Correo electrónico: Genevieve.Curtis@va.gov
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Periodo de tiempo: Visit 0 (Screening) through Visit 5 (Week 12)
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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).
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Visit 0 (Screening) through Visit 5 (Week 12)
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Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)
Periodo de tiempo: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
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Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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Change in Blood Pressure During In-Lab Observation (Aim 1)
Periodo de tiempo: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
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Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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Occurrence of Adverse Events During In-Lab Observation (Aim 1)
Periodo de tiempo: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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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.
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Visit 1 (Day 1; pre-dose through 5 hours post-dose)
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Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) through Visit 5 (Week 12)
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Heart rate (beats per minute) measured at each study visit and daily at home.
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Visit 2 (Day 2) through Visit 5 (Week 12)
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Change in Blood Pressure During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) through Visit 5 (Week 12)
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Blood pressure (mmHg) will be measured at each study visit and daily at home
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Visit 2 (Day 2) through Visit 5 (Week 12)
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Occurrence of Adverse Events During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) through Visit 5 (Week 12)
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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.
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Visit 2 (Day 2) through Visit 5 (Week 12)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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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)
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Visit 2 (Day 2) and Visit 5 (Week 12)
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Change in Plasma Leptin During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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Plasma leptin levels measured (pg/ml) at Visit 2 (Day 2) and Visit 5 (Week 12)
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Visit 2 (Day 2) and Visit 5 (Week 12)
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Change in Plasma Adiponectin During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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Plasma adiponectin levels (µg/mL) measured at Visit 2 (Day 2) and Visit 5 (Week 12)
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Visit 2 (Day 2) and Visit 5 (Week 12)
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Change in Lipids (HDL, LDL, and Triglycerides)
Periodo de tiempo: Visit 0 (Screening) and Visit 5 (Week 12)
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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)
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Visit 0 (Screening) and Visit 5 (Week 12)
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Change in Fasting Plasma Insulin
Periodo de tiempo: Visit 0 (Screening) and Visit 5 (Week 12)
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Fasting plasma insulin levels (µIU/mL) measured at Visit 0 (Screening) and Visit 5 (Week 12)
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Visit 0 (Screening) and Visit 5 (Week 12)
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Change in Fasting Blood Glucose
Periodo de tiempo: Visit 0 (Screening) and Visit 5 (Week 12)
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Fasting blood glucose levels (mg/dL) measured at Visit 0 (Screening) and Visit 5 (Week 12)
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Visit 0 (Screening) and Visit 5 (Week 12)
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Change in HOMA-IR From Screening (Aim 2)
Periodo de tiempo: Visit 0 (Screening) and Visit 5 (Week 12)
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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)
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Visit 0 (Screening) and Visit 5 (Week 12)
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Change in HbA1c From Screening
Periodo de tiempo: Visit 0 (Screening) and Visit 5 (Week 12)
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Hemoglobin A1c (HbA1c) levels (%) measured at Visit 0 (Screening) and Visit 5 (Week 12)
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Visit 0 (Screening) and Visit 5 (Week 12)
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Change in C-Reactive Protein (CRP)
Periodo de tiempo: Visit 0 (Screening) and Visit 5 (Week 12)
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C-reactive protein (CRP) levels (mg/L ) measured at Visit 0 (Screening) and Visit 5 (Week 12)
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Visit 0 (Screening) and Visit 5 (Week 12)
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Change in Body Composition by DXA During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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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)
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Visit 2 (Day 2) and Visit 5 (Week 12)
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Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2) and Visit 5 (Week 12)
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Waist and Hip circumference (cm) measured by tape measure at Day 2 and at Week 12.
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Visit 2 (Day 2) and Visit 5 (Week 12)
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Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2)
Periodo de tiempo: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
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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)
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Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Resistencia a la insulina
- Hiperinsulinismo
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Parálisis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Síndrome metabólico
- Lesiones de la médula espinal
- Cuadriplejia
- Paraplejía
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Alcaloides
- Benzazepines
- Alcaloides de amaryllidaceae
- Galantamina
Otros números de identificación del estudio
- 25-0846
- C41213GM (Otro número de subvención/financiamiento: NYSCIRB NY State Department of Health)
- 1349754 (Otro número de subvención/financiamiento: Craig H. Neilsen Foundation)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
All data must be de-identified in accordance with institutional, local, state, and federal guidelines.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .