Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: AV-001 or Placebo Injection.
- Кому может быть актуально
- Состояния в реестре: Hemodialysis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Exploratory Study to Evaluate the Neuroprotective Effects of AV-001 on Hemodialysis-induced Brain Injury Via Cerebrovascular Stabilization in Chronic Hemodialysis Patients
Обзор
Cognitive decline is increasingly recognized among patients receiving maintenance hemodialysis (HD). This can include trouble remembering, slower thinking or mentally feeling foggy. This research is being done to determine if a new medication (AV-001) can protect the brain from injury caused by hemodialysis by strengthening blood vessels in the brain and reducing inflammation. If successful, this research could lead to better protection for the brains of people undergoing regular dialysis, potentially reducing the risk of cognitive decline and stroke.
Подробное описание
Hemodialysis provides life-sustaining treatment for many chronic kidney disease patients around the world. Moderate to severe cognitive impairment is very common in HD patients with up to 70% being affected who are ≥ 55 years of age and \~ 10% in those between 21-39 years of age. Significant cognitive impairment is evident within 6 months of starting HD.
This study is a phase 2 exploratory study in patients receiving hemodialysis treatments. Investigators will recruit 60 patients from the renal program at the London Health Sciences Centre.
Study participants will receive AV-001 (low or high dose) or placebo 60 minutes prior to HD initiation at 3 HD treatment sessions within 1 week (Monday, Wednesday and Friday)
Study participants will also undergo:
* Vital sign collection (blood pressure and heart rate) * Blood collection * Cognitive assessments * Vascular ultrasound * MRI
Вмешательства
- Препарат AV-001 or Placebo Injection
AV-001 or Placebo administered via IV bolus injection.
Первичные конечные точки
- Evaluate the effect of AV-001 (high dose, low dose) on structural brain injury associated with HD, using MRI as compared to placebo controls. [Срок оценки: Before and after dialysis on study visit day 3.]
Вторичные конечные точки (12)
- Evaluate circulating biomarkers of vascular injury (S-100β ) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (transthyretin) [Срок оценки: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (TNF-a) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (IL-6) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (serum lipopolysaccharide) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (complete blood count) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (urea) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (electrolytes) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulating biomarkers of vascular injury (dialysate composition) [Срок оценки: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (Clot) [Срок оценки: Study visit Day 1 to Study Visit Day 3 (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (AV-001 specific biomarkers) [Срок оценки: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate variations in cognitive assessment performance scores using Montreal Cognitive Assessment (MoCA) [Срок оценки: Study Visit Day 1 to Study Visit Day 3 (1 week)]
Критерии участия
Критерии включения
- Ability to provide informed consent
- Male and non-pregnant female patients (>18 years old)
- HD for ≥ 3 months
- Thrice weekly HD schedule
Критерии исключения
- HD <90 days
- Contraindication to MRI
- Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) <18 or formal diagnosis of dementia)
- Previous clinical stroke
- Pregnancy, breastfeeding, or intending pregnancy
- Intradialytic hypotension event (defined as: drop in SBP ≥40mmHg + symptoms + intervention) in previous month as evidenced by HD record
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
Канада · 1 центр
- London Health Sciences Centre — London
Идентификаторы
NCT: NCT07234890 · 15976