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

2026년 5월 28일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

60

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • New Jersey
      • West Orange, New Jersey, 미국, 07052
        • 아직 모집하지 않음
        • Kessler Institute for Rehabilitation
        • 부수사관:
          • James Wilson, DO
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Chris Cirnigliaro, PhD
        • 수석 연구원:
          • Trevor Dyson-Hudson, MD
    • New York
      • Manhasset, New York, 미국, 11030
        • 모병
        • Northwell Health
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Ona Bloom, PhD
        • 부수사관:
          • Adam B Stein, MD
      • The Bronx, New York, 미국, 10468
        • 모병
        • James J. Peters VA Medical Center
        • 수석 연구원:
          • Jill Wecht, EdD
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • 라자다인 ER

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Northwell Health

협력자

Bronx Veterans Medical Research Foundation, Inc
Kessler Institute for Rehabilitation

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 19일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 25-0846
  • C41213GM (기타 보조금/기금 번호: NYSCIRB NY State Department of Health)
  • 1349754 (기타 보조금/기금 번호: Craig H. Neilsen Foundation)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다