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Идёт набор NCT06534658

Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia

— Наблюдательное Alzheimer Disease Image

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, Image. Базовые параметры: 50 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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Обзор

This project is a multicenter observational study that establishes a longitudinal cohort of patients with Alzheimer's disease and other dementias based on neuroimaging, molecular imaging, biological and digital markers to explore new solutions such as dementia disease mechanism, diagnosis, condition evaluation, and prognosis assessment.

Подробное описание

This project will build a longitudinal database based on multimodal MRI imaging information of dementia subjects, various body fluid or digital markers, and a cohort. The convolutional neural network algorithm will be used to explore the imaging characteristics of healthy controls, AD, FTD, and DLB, develop an early prediction model for degenerative dementia, and achieve early differential diagnosis of different dementia subtypes. This study further performed GE180, ASEM, and exendin-4 radionuclide imaging on some subjects who completed conventional PET (AV45, Tauvir, and FDG) imaging to explore the diagnostic efficacy of these three probes as new diagnostic probes for early AD. In addition, through longitudinal follow-up of Aβ-positive MCI patients, multimodal MRI and PET image fusion technology were used to explore the changes in fused images during their conversion to AD in order to obtain early and accurate diagnostic markers.

Первичные конечные точки

  • The change of incidence of cognitive impairment [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
Вторичные конечные точки (12)
  • The change of Mini-Mental State Examination (MMSE) [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Montreal cognitive assessment-Basic (MoCA) [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Auditory verbal learning test (AVLT) [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of structural MRI [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of functional MRI [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of magnetic susceptibility [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of perfusion MR imaging [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • Positron emission tomography (PET)-MRI [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of blood biomarker [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of speech information [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Activities of daily living (ADL) [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]
  • The change of Geriatric Depression Scale (GDS) [Срок оценки: baseline, 1 year, 2 year, 3 year, 4 year]

Критерии участия

Критерии включения

  • Patients aged ≥50 and ≤85 years old, male or female;
  • Meet the diagnostic criteria for dementia or MCI;
  • Neuropsychological score: MMSE 15-28 points, CDR ≤ 1 point; ④ Patients and their families are informed and sign the informed consent form

Критерии исключения

  • The presence of other neurological diseases that may cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
  • The presence of other systemic diseases that may cause cognitive impairment (such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
  • Suffering from a disease that makes it impossible to cooperate with cognitive examinations;
  • The presence of contraindications to MRI;
  • The presence of mental and neurological retardation;
  • Refusing to draw blood;
  • Refusing to sign the informed consent form.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 8 центров
  • Chinese People's Liberation Army General Hospital — Пекин
  • First Affiliated Hospital of Zhejiang University School of Medicine — Hanzhong
  • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine — Cangzhou
  • The Second Hospital of Hebei Medical University — Shijiazhuang
  • Qilu Hospital of Shandong University, Qingdao Branch — Qingdao
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
  • The First Affiliated Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT06534658 · BP-MIMI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗