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Набор скоро начнётся NCT07681219

LRRK2 (Leucine-Rich Repeat Kinase 2) Parkinson's Disease Fingerprint

Без фазы С лечением Parkinsons Disease (PD) LRRK2

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: The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data.
Кому может быть актуально
Состояния в реестре: Parkinsons Disease (PD), LRRK2. Базовые параметры: 30 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
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

LRRK2 Associated Parkinson's Disease: Definition of a Clinical, Molecular and Neurophysiological Fingerprint

Обзор

The goal of this interventional monocentric study is to identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis and deep clinical phenotyping. Patients who meet the inclusion criteria, after signing the informed consent form will be clinically evaluated by a neurologist expert in movement disorders. Eventually, patients will undergo a blood sample collection, a brain MRI, and a high density EEG. All data will be collected using an ad hoc electronic Case Report Form (CRF) developed for the study

Вмешательства

  • Диагностический тест The interventions of the study are the study of blood biomarkers and neuroimaging and neurophysiological data
    * Blood sample collection and markers analysis * Brain 1.5 T MRI * High density EEG

Первичные конечные точки

  • 1) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 2) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 3) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 4) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 5) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 6) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 7) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 8) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 9) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping. [Срок оценки: Through the study completion, about 3 years]
  • 10) To identify molecular and clinical markers of LRRK2-related Parkinson's disease through blood markers analysis, deep clinical phenotyping [Срок оценки: Through the study completion, about 3 years]
Вторичные конечные точки (2)
  • 1) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease [Срок оценки: Through study completion, about 3 years]
  • 2) Mechanistic Modeling of LRRK2-Associated Parkinson's Disease [Срок оценки: Through the study completion, about 3 years]

Критерии участия

Критерии включения

  • age 30-80 years,
  • clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria,
  • Hoehn \& Yahr (H\&Y) stage between 1 and 3,
  • 10 patients with a LRRK2 associated parkinsonism and 10 with sporadic PD tested with a NGS panel and MLPA for PD associated genes,
  • ability to provide informed consent.

Критерии исключения

  • Active or history of other neurological disorders,
  • active infectious disease or history within the previous 4 weeks,
  • continuative therapy (at least 1 week) with NSAIDs or steroids within the previous 12 weeks,
  • active malignancy, autoinflammatory or autoimmune diseases or history within the previous 3 years;
  • alcohol or drug abuse or dependence
  • any contraindication to the execution of the MRI (including claustrophobia).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07681219 · 27556

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗