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Набор скоро начнётся NCT07544953

Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Без фазы С лечением Parkinson 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: Lecanemab, Lecanemab non-administration group.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: 50 лет — 90 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

Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease

Обзор

This study aimed to determine the efficacy of amyloid clearance of lecanemab in patients with Parkinson's disease (PD) with amyloid co-pathology. Lecanemab, an anti-amyloid monoclonal antibody, was apporoved by the US FDA in July 2023 and in South Korea in May 2024, as a disease-modifying therapy based on its clinical efficacy and reduction of amyloid plaques in patients with early-stage Alzheimer's disease (AD). AD pathology is also common in PD, and approximately 35% of patients with PD dementia have co-existing AD pathology. Currently, no mediations have been developed to slow the progression of PD. Therefore, this study aimed to determine whether reducing the amyloid burden in patients with PD with co-exsistent AD pathology could potentially slow disease progression. To test it, patients with PD with mild cognitive impairment or early dementia, who were confirmed to have amyloid deposition through amyloid imaging, would be enrolled as a treatment arm, and the degree of reduction of amyloid plaque after 18 months of lecanemab administration would be investigated.

Подробное описание

This study plans to consecutively enroll the patients with Parkinson's disease (PD) who have confirmed amyloid deposition on amyloid imaging and meet the indications for lecanemab administration. After a thorough explanation of lecanemab administration, patients who consent to the treatment would be enrolled. Patients assinged to the treatment arm would receive standard lecanemab treatment (10mg/kg intravenous infusion every two weeks for 18 months) and standard PD care. Patients who do not consent to the administration of lecanemab would receive stadnard care for PD and be monitored their progress without any further intervention.

Вмешательства

  • Препарат Lecanemab
    Patients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months.
  • Другое Lecanemab non-administration group
    Patients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period

Первичные конечные точки

  • Changes in amyloid dposition on amyloid imaging scans [Срок оценки: Change from baseline to 18 months]
Вторичные конечные точки (7)
  • longitudinal changes in the MMSE score [Срок оценки: Change from baseline to 18 months]
  • longituidnal changes in UPDRS-III scores. [Срок оценки: Change from baseline to 18 months]
  • Longitudinal changes in the plasma and cerebrospinal fluid biomarkers [Срок оценки: Change from baseline to 18 months]
  • longitudinal changes in the MoCA score. [Срок оценки: Change from baseline to 18 months]
  • longitudinal changes in CDR-SB. [Срок оценки: Change from baseline to 18 months]
  • longituidnal changes in composite scores of each cognitive domain. [Срок оценки: Change from baseline to 18 months]
  • longituidnal changes in levodopa-equivalent doses per body weight [mg/kg]. [Срок оценки: Change from baseline to 18 months]

Критерии участия

Критерии включения

  • Patients diagnosed with Parkinson's disease
  • Amyloid deposition confirmed by FBB PET
  • Mild cognitive impairment or early dementia (CDR 0.5 or 1) on neuropsychological tests
  • Adults aged 50-90 years

Критерии исключения

  • Cases in which lecanemab administration is contraindicated (based on recommendations from the Korean Dementia Association)
  • Cases in which neuropathologies other than Parkinson's disease or Alzheimer's disease are suspected as the underlying disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Yonsei University College of Medicine — Seoul

Идентификаторы

NCT: NCT07544953 · 4-2025-1358

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗