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Набор скоро начнётся NCT05667935

Cognitive Impairment Cohort Study of the Elderly Population in SheMountain

— Наблюдательное Alzheimer Disease Dementia Neurodegenerative Diseases Cognitive Impairment

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: Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment. Базовые параметры: от 60 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
Китай
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

Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort

Обзор

This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood, APOE genotype, brain MRI, speech information, AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET were collected and analyzed. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.

Подробное описание

This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood serum Aβ40, Aβ42, p-tau 181, 217, urine proteomic analysis, APOE genotype analysis, brain MRI, and speech information were collected and analyzed. After initial screening 20% of patients with clinically confirmed MCI and AD were randomly selected for AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.

Первичные конечные точки

  • The change of incidence of cognitive impairment [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
Вторичные конечные точки (10)
  • The change of Mini-Mental State Examination (MMSE) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of Montreal cognitive assessment-Basic (MoCA) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of Auditory verbal learning test (AVLT) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of Geriatric Depression Scale (GDS) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of 36-Item Short Form Survey (SF-36) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of MRI neuroimaging [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • Positron emission tomography (PET)-CT [Срок оценки: baseline]
  • The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of Activities of daily living (ADL) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
  • The change of speech information [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]

Критерии участия

Критерии включения

  • All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
  • Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
  • Agree to participate in this study and sign the informed consent form. And promise to abide by the research procedures, and cooperate with the implementation of the whole process of research

Критерии исключения

  • Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate
  • Uncorrectable visual or auditory impairment that hampers the completion of related examination.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT05667935 · SheMountain-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗