Cognitive Impairment Cohort Study of the Elderly Population in YuGarden
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, Neurodegenerative Diseases, Cognitive Impairment, Mild Cognitive Impairment. Базовые параметры: 60 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
- 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: YuGarden Cohort
Обзор
The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China. The main questions it aims to answer are: * incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease) * to build a predictive model for the progression of cognitive impairment
Подробное описание
This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.
Первичные конечные точки
- Incidence of cognitive impairment [Срок оценки: 8 years]
Вторичные конечные точки (12)
- The change of Mini-Mental State Examination (MMSE) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of Barthel Index for Activities of Daily Living (ADL) [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of blood biomarkers [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of urine biomarkers [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of feces biomarkers [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of gingival crevicular fluid biomarkers [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of electroencephalogram (EEG) [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]
- The change of structural MRI [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of functional MRI [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of magnetic susceptibility [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of perfusion MR imaging [Срок оценки: baseline, 2 year, 4 year, 6 year, 8 year]
Критерии участия
Критерии включения
- The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
- Non-AD patients.
- The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.
- The participants agree to participate in this study and sign the informed consent form.
Критерии исключения
- Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.
- Participants who have visual or auditory impairment that hampers the completion of related examination.
- Situations when magnetic resonance imaging or other examinations are contraindicated.
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 Jiao Tong University School of Medicine — Шанхай
Идентификаторы
NCT: NCT06325527 · YuGarden-01