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Идёт набор NCT07089303

Alzheimer's Disease Multinuclear Imaging Neuro-Enhanced Resolution (AD-MINER)

— Наблюдательное Alzheimer Disease Mild Cognitive Impairment Due to Alzheimer's Disease

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, Mild Cognitive Impairment Due to Alzheimer's Disease. Базовые параметры: 55 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

Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease

Обзор

This single-center prospective cohort study will enroll 750 participants (250 cognitively Normal (CN) individuals, 250 with mild cognitive impairment (MCI), and 250 with Alzheimer's disease (AD)). At baseline and at annual follow-ups, participants will undergo 3 Tesla (3 T) and 7 Tesla (7 T) multimodal magnetic resonance imaging (MRI) scans, blood biomarker testing, genotyping, and cognitive assessments to identify early imaging biomarkers and construct models of disease progression.

Подробное описание

This prospective, single-center cohort will enroll 750 participants (normal controls, MCI, and AD) for at least four years of follow-up. Using ultra-high field 7T multimodal and multinuclear (hydrogen-1 \[¹H\], sodium-23 \[²³Na\]) MRI, combined with plasma biomarkers and genetic data, the study aims to identify early neuroimaging biomarkers and clarify the clinical significance of sodium metabolic abnormalities in AD. Structural, functional, and sodium imaging data will be integrated with neuropsychological and blood-based markers, using artificial intelligence for early diagnosis and risk prediction. The study will address technical gaps in early detection and provide the first standardized 7T AD neuroimaging database for the Chinese population.

Первичные конечные точки

  • Change from Baseline in Regional Brain Sodium Concentration (mmol/L) Measured by 7 T ²³Na-MRI [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Resting-State Fractional Amplitude of Low-Frequency Fluctuations（fALFF, unitless) Measured by 7 T fMRI [Срок оценки: baseline to 1year]
  • Change from Baseline in Mean Apparent Diffusion Coefficient (ADC) (×10-³ mm²/s) Derived from Dynamic Diffusion-Weighted Imaging (DynDWI) [Срок оценки: Baseline to 1 year]
  • Change From Baseline in Fractional Anisotropy (FA, unitless) [Срок оценки: Baseline to 1 year]
  • Change From Baseline in Mean Diffusivity (MD, ×10-³ mm²/s) [Срок оценки: Baseline to 1 year]
Вторичные конечные точки (12)
  • Change from Baseline in Montreal Cognitive Assessment (MoCA) Total Score (0-30, points) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Clinical Dementia Rating (CDR) Global Score (0-3, points) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Mini-Mental State Examination (MMSE) Total Score (0-30, points) [Срок оценки: Baseline to 1 year]
  • Change From Baseline of the Auditory Verbal Learning Test (AVLT) Total Learning Score [Срок оценки: baseline to 1year]
  • Change from Baseline in Rey-Osterrieth Complex Figure Test (ROCF) Combined Recall Score (0-72, points) [Срок оценки: baseline to 1year]
  • Change From Baseline of the Clock Drawing Test (CDT) Score (0-5, points) [Срок оценки: Baseline to 1 year]
  • Change From Baseline of the Boston Naming Test (BNT) Total Score (0-60, points) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Digit Span Test (DST) Total Score (0-15, points) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Symbol Digit Modalities Test (SDMT) Total Score (correct matches per 90 s) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Stroop Color-Word Test (SCWT) Incongruent Condition Completion Time (seconds) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Neuropsychiatric Inventory (NPI) Total Score (0-144, points) [Срок оценки: Baseline to 1 year]
  • Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score (0-56, points) [Срок оценки: Baseline to 1 year]

Критерии участия

Критерии включения

  • Age 55-90 years (inclusive).
  • Willing and able to participate in baseline assessment and longitudinal follow-up; voluntary provision of biospecimens and personal information, and commitment to complete all follow-up visits.
  • Able to undergo MRI scanning (no contraindications to MRI).
  • Group-specific cognitive criteria:

CN: No subjective memory complaints beyond age expectation (confirmed by study partner); MMSE score 26-30 (inclusive; exceptions permitted for participants with <8 years of education with principal investigator approval; CDR = 0, memory box = 0; Normal cognitive and daily functioning, no significant impairment.

MCI: Subject, partner, or physician reports subjective memory concerns; MMSE criteria same as CN group; CDR = 0.5 (memory box ≥0.5); General cognition and function relatively preserved; does not meet criteria for AD.

AD: Subject, partner, or physician reports subjective memory concerns; MMSE score <26 (inclusive; exceptions as above); CDR = 0.5 or 1.0; Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) probable AD diagnostic criteria or 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (e.g., positive Pittsburgh compound B (PIB) and tau).

Критерии исключения

  • Self-reported or MRI-detected major neurological diseases other than AD: including but not limited to stroke (cerebral hemorrhage, infarction), congenital intellectual disability, intracranial tumors, epilepsy, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, severe head trauma with persistent deficits, etc.
  • Severe psychiatric disorders (e.g., schizophrenia requiring medication control) or other known brain structural abnormalities.
  • Significant organ failure (heart, liver, kidney, etc.), malignant tumors, or short life expectancy making completion of follow-up unlikely.
  • Contraindications to MRI (e.g., claustrophobia, incompatible pacemaker, aneurysm clip, artificial heart valve, cochlear implant, or other metallic implants).
  • Other clinical history or examination findings judged by investigators as potentially unsafe for MRI or follow-up.
  • Use of investigational drugs within one month prior to enrollment or during the study.

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
  • Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07089303 · ADMINER-PLAGH-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗