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Идёт набор NCT07353463

Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

— Наблюдательное Parkinson's Disease (PD) Multiple System Atrophy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD), Multiple System Atrophy. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational cohort studyis to establish a high-quality clinical cohort of Parkinson's disease (PD) and multiple system atrophy (MSA) patients in Shanghai, in order to improve early diagnosis, precise subtyping, disease monitoring, and to provide a resource for translational research and novel therapy development. The main questions it aims to answer are: * Can multimodal data (clinical, imaging, electrophysiology, biospecimens, and genetics) help identify early biomarkers for PD and MSA? * Can precise subtyping and long-term monitoring predict disease progression and therapeutic response? Researchers will compare 600 PD patients and 100 MSA patients to evaluate differences in clinical features, biomarkers, imaging, and prognosis. Participants will: * Provide informed consent and complete baseline demographic and medical history collection. * Undergo standardized clinical evaluations, including motor and non-motor symptom scales, cognitive and quality-of-life assessments. * Provide biological samples (blood, saliva, optional CSF). * Receive brain imaging (MRI, optional PET/SPECT) and electrophysiological recordings (EEG, fNIRS). * Participate in longitudinal follow-up visits every 6 months for repeat assessments. This study will create a sustainable, multicenter, and sharable cohort platform to support early identification, personalized intervention, and therapeutic development for neurodegenerative diseases

Первичные конечные точки

  • Change from baseline in motor symptom severity assessed by MDS-UPDRS Part III [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in Hoehn & Yahr stage [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in Brief Pain Inventory (BPI) pain severity score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLSS) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in Epworth Sleepiness Scale (ESS) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]
  • Change from baseline in Hamilton Anxiety Rating Scale (HAMA) score [Срок оценки: From baseline through 6-month and 12-month follow-up assessments]

Критерии участия

  • Inclusion Criteria for Clinical PD Group:
  • Patients with a clinical diagnosis of Parkinson's disease (PD) according to the \_Chinese Diagnostic Criteria for Parkinson's Disease (2016 edition)\_.
  • Willingness to undergo biospecimen collection, including cerebrospinal fluid (optional), blood, and saliva, and to complete neuroimaging examinations (MRI, PET/SPECT) and disease-specific clinical assessments.
  • Provision of written informed consent
  • Inclusion Criteria for Clinical MSA Group:
  • Patients with a clinical diagnosis or clinically probable multiple system atrophy (MSA) according to the Chinese Expert Consensus on the Diagnostic Criteria for MSA (2022).
  • Willingness to undergo biospecimen collection, including cerebrospinal fluid (optional), blood, and saliva, and to complete neuroimaging examinations (MRI, PET/SPECT) and disease-specific clinical assessments.
  • Provision of written informed consent.
  • Exclusion Criteria for All Participants:
  • Patients with an unclear or uncertain diagnosis.
  • History of stroke, head trauma, hydrocephalus, brain tumor, intracranial hypertension, or intracranial surgery.
  • Evidence of intracranial organic lesions on CT/MRI.
  • Severe anxiety, depression, or schizophrenia.
  • Severe comorbidities involving the heart, lungs, liver, kidneys, endocrine system, or hematological system.
  • Presence of aphasia, severe dysarthria, or other conditions that significantly impair clinical assessments.
  • Anticipated poor compliance.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07353463 · Parkinson's Disease Cohort · SHDC2025CCS043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗