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Идёт набор NCT05623124

Ruijin Neurobank of Alzheimer's Disease and Dementia

— Наблюдательное Dementia

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: No intervention.
Кому может быть актуально
Состояния в реестре: Dementia. 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
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

Neurovascular Coupling and Digital Biomarkers in Alzheimer's Disease

Обзор

The goal of this observational study is to learn about neuroimage and biomarkers in the Alzheimer's continuum. The main questions it aims to answer are: * How is the neurovascular coupling during AD pathogenesis? * How is the pattern/mapping of alterations in AD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.

Подробное описание

The observational study recruits participants from clinics and communities with cognitive impairment. Healthy volunteers will also be recruited as controls. Longitudinal observation of these participants will help demonstrate AD biomarkers' significance during AD pathogenesis.

The investigators aim to build an aging population cohort covering the AD continuum and explore key biomarkers for AD. All participants will have multi-modal MRI scanning, PET scanning with different tracers, and blood test. With MRI scanning, the investigators are exploring the effect of neurovascular coupling in AD pathogenesis. In addition, the investigators are trying to find patterns/mapping of AD biomarkers with PET and blood tests. Beyond this, more neuroimage markers and digital biomarkers will be tested in the cohort.

Вмешательства

  • Другое No intervention
    No intervention

Первичные конечные точки

  • MMSE [Срок оценки: once a year]
  • Clock drawing test [Срок оценки: once a year]
  • Complex figure test [Срок оценки: once a year]
  • AVLT [Срок оценки: once a year]
  • SDT [Срок оценки: once a year]
  • TMT [Срок оценки: once a year]
  • Naming test [Срок оценки: once a year]
  • Fluency [Срок оценки: once a year]
Вторичные конечные точки (5)
  • Neuroimage markers from MRI [Срок оценки: once a year]
  • Neuroimage functional markers from fMRI [Срок оценки: once a year]
  • Beta-amyloid [Срок оценки: once a year]
  • Tau [Срок оценки: once a year]
  • SV2A [Срок оценки: once a year]

Критерии участия

Критерии включения

  • Male and female aged 50 to 90 years old;
  • In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" and "Dementia" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011);
  • The Hamilton depression rating scale/17 edition (HAMD) total score<10;
  • The clinical dementia rating (CDR) is 0.5 or above;
  • Neurological examination: no obvious signs;
  • Participants should have a caregiver stable and reliable.
  • Education: primary school (grade 6) or above. They have the ability to complete tests for cognitive ability and have the ability and time to complete regulation of cognitive training

Критерии исключения

  • Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, CJD, Huntington's and Parkinson's disease, DLB, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia.
  • The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc.);
  • Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium;
  • There are unstable or serious heart, lung, liver, kidney, and hematopoietic system diseases; Poor prognosis because of malignant diseases such as tumors.
  • Vision or hearing problems that lead to poor performance on cognitive tests;
  • Two years history of severe alcoholism, and drug abuse;
  • The researchers believe that the subjects could not complete the study.
  • Contraindication of MRI or PET scanning.

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

Публикации

  • Zheng Y, Kang L, Yang X, Zhou R, Chen H, Wang W, Xu X, Xu W, Liu J, Li B, Deng Y. Stage-dependent relationship between sleep duration and cortical tau deposition in cognitively impaired individuals: A cross-sectional study. J Alzheimers Dis. 2026 Jul 1:13872877261462419. doi: 10.1177/13872877261462419. Online ahead of print. PMID 42383821
  • Xu X, Yang X, Zhang J, Wang Y, Selim M, Zheng Y, Shen R, Sun L, Huang Q, Wang W, Xu W, Guan Y, Liu J, Deng Y, Xie F, Li B; Alzheimer's Disease Neuroimaging Initiative (ADNI). Choroid plexus free-water correlates with glymphatic function in Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70239. doi: 10.1002/alz.70239. PMID 40394891

Идентификаторы

NCT: NCT05623124 · RJNeuroBank-Dementia

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗