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

2026年5月28日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • New Jersey
      • West Orange、New Jersey、アメリカ、07052
        • まだ募集していません
        • Kessler Institute for Rehabilitation
        • 副調査官：
          • James Wilson, DO
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Chris Cirnigliaro, PhD
        • 主任研究者：
          • Trevor Dyson-Hudson, MD
    • New York
      • Manhasset、New York、アメリカ、11030
        • 募集
        • Northwell Health
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Ona Bloom, PhD
        • 副調査官：
          • Adam B Stein, MD
      • The Bronx、New York、アメリカ、10468
        • 募集
        • James J. Peters VA Medical Center
        • 主任研究者：
          • Jill Wecht, EdD
        • コンタクト：
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
他の名前：
  • ラザダインER

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Northwell Health

協力者

Bronx Veterans Medical Research Foundation, Inc
Kessler Institute for Rehabilitation

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月15日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年5月19日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 25-0846
  • C41213GM (その他の助成金/資金番号：NYSCIRB NY State Department of Health)
  • 1349754 (その他の助成金/資金番号：Craig H. Neilsen Foundation)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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

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米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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