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Идёт набор NCT07496021

Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

Без фазы С лечением Early Alzheimers Disease

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: L. lactis CKDB001, Placebo.
Кому может быть актуально
Состояния в реестре: Early Alzheimers Disease. Базовые параметры: 55 лет — 85 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
South Korea
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, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

Обзор

Randomized, Placebo-Controlled, Double-Blind, 24-Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of L. Lactis CKDB001 in Subjects With Early Alzheimer's Disease

Вмешательства

  • Препарат L. lactis CKDB001
    Oral Capsule
  • Препарат Placebo
    Oral Capsule

Первичные конечные точки

  • Change from baseline in the ADAS-Cog 14 total score at Weeks 12 and 24 [Срок оценки: Baseline, Week 12, Week 24]
  • Change from baseline in the ADAS-Cog 14 memory box score at Weeks 12 and 24 [Срок оценки: Baseline, Week 12, Week 24]
  • Change from baseline in the ADCS-MCI-ADL score at Weeks 12 and 24 [Срок оценки: Baseline, Week 12, Week 24]
  • Change from baseline in the K-MMSE score at Weeks 12 and 24 [Срок оценки: Baseline, Week 12, Week 24]
  • Change from baseline in the Global Clinical Dementia Rating (CDR) score at Week 24 [Срок оценки: Baseline, Week 24]
  • Change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at Week 24 [Срок оценки: Baseline, Week 24]
  • Change from baseline in amyloid PET imaging biomarkers at Week 24 [Срок оценки: Baseline, Week 24]
  • Change from baseline in blood-based Alzheimer's disease-related biomarkers at Week 24 [Срок оценки: Baseline, Week 24]
  • Change from baseline in blood cytokine levels at Week 24 [Срок оценки: Baseline, Week 24]

Критерии участия

Критерии включения

  • Male and female adults aged ≥55 and ≤85 years at the time of written consent
  • Subjects with a Korean Mini-Mental State Examination (K-MMSE) score of 20 to 28
  • Have a global Clinical Dementia Rating (CDR) score of 0.5 to 1 and a CDR Memory Box score of 0.5 or greater
  • Subjects who test positive for amyloid on Positron Emission Tomography (PET)

Критерии исключения

  • Subjects with clinically significant diseases other than Alzheimer's disease that may confound cognitive assessment
  • History of central nervous system (CNS) diseases
  • Active central nervous system (CNS) infection capable of affecting cognitive function, or a history of infection resulting in neurological sequelae
  • Structural brain abnormalities identified on screening MRI that could account for cognitive impairment
  • Abnormal thyroid function identified at screening
  • Vitamin B12 deficiency identified at screening
  • History of seizure disorder or epilepsy
  • History or suspicion of alcohol or substance abuse/dependence
  • History of psychiatric disorders, including schizophrenia, bipolar disorder, or clinically significant major depressive disorder, with current active symptoms
  • History of malignancy diagnosed or recurrent within 5 years prior to screening
  • History of a major cardiovascular event within 12 months prior to screening
  • Cardiovascular disease requiring the administration of anticoagulants
  • Severe or active infectious disease requiring treatment with antibiotics or antivirals within 4 weeks prior to randomization, or expected to require such treatment during the study period
  • Clinically significant gastrointestinal disorders within 3 months prior to screening, or conditions that may lead to malabsorption
  • Treatment with any disease-modifying therapy for Alzheimer's disease within 1 year prior to screening
  • Initiation or dosage/regimen changes of symptomatic treatments for dementia within 12 weeks prior to screening
  • Chronic use of medications acting on the CNS or those that may affect cognitive function within 8 weeks prior to screening
  • Regular use of medications that may alter the gut microbiota within 4 weeks prior to screening

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
Двойное слепое
Основная цель
Лечение

Центры проведения

South Korea · 2 центра
  • Yonsei University Yongin Severance Hospital — Gyeonggi-do
  • Yonsei University Severance Hospital — Seoul

Идентификаторы

NCT: NCT07496021 · CKDB001-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗