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Идёт набор NCT07580703

A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy

Фаза I С лечением AD - Alzheimer's Disease MCI

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: [18F]Flortaucipir Injection.
Кому может быть актуально
Состояния в реестре: AD - Alzheimer's Disease, MCI. 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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Официальное название

A Non Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects

Обзор

This is a non randomized, open-label Phase I study in Chinese participants. The goal of this clinical trial is to evaluate the safety and tolerability of a radioactive imaging agent called \[18F\]Flortaucipir Injection, which is used during a PET scan. The study will also measure how the agent moves through the body (pharmacokinetics), where it goes (biodistribution), the amount of radiation exposure (radiation dosimetry), and how well it may help detect signs of disease (preliminary diagnostic efficacy).

Вмешательства

  • Препарат [18F]Flortaucipir Injection
    A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).

Первичные конечные точки

  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: 6 days post-injection]
Вторичные конечные точки (12)
  • Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound [Срок оценки: Up to 360 mins]
  • Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound [Срок оценки: Up to 360 mins]
  • Terminal Half-Life (t½) of Unmetabolized Parent Compound [Срок оценки: Up to 360 mins]
  • Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound [Срок оценки: Up to 360 mins]
  • Percentage of Unmetabolized Parent Compound in Plasma [Срок оценки: Up to 360 mins]
  • Urinary Radioactive Excretion Rate [Срок оценки: 0-60, 60-120, 120-240, 240-360 mins post-injection]
  • Cumulative Urinary Excretion of Radioactivity [Срок оценки: Up to 360 mins post-injection]
  • Percentage of Unmetabolized Parent Compound and Metabolites in Urine [Срок оценки: Up to 360 mins post-injection]
  • Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID) [Срок оценки: Up to 240 mins post-injection]
  • Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues [Срок оценки: Up to 240 mins post-injection]
  • Residence Time (Source Organ Time-Integrated Activity) [Срок оценки: Up to 240 mins post-injection]
  • Absorbed Dose to Target Organs/Tissues [Срок оценки: Up to 240 mins post-injection]

Критерии участия

Критерии включения

  • Signed informed consent form (ICF).
  • Male or female aged 50-85 years.
  • Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.
  • Meet the following criteria related to cognitive impairment:
  • CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
  • MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
  • AD: Meet core criteria for probable AD dementia, Aβ-PET positive, MRI showing neurodegenerative changes.
  • Fertile individuals: No plan for reproduction, sperm/egg donation within 6 months after signing ICF and until 6 months after study drug administration; and agreement to use highly effective contraception (including partner).

Критерии исключения

  • Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
  • Major surgery within 1 month prior to screening, or planned surgery during the study period.
  • Known allergy to radioactive radiation, alcohol, \[18F\]Flortaucipir injection, or its excipients, or other severe allergic reactions.
  • Cognitive impairment due to causes other than AD.
  • Clinically significant infarction or probable multi-infarct dementia.
  • Current clinically significant psychiatric illness (e.g., major depression, schizophrenia).
  • History of epilepsy or seizures (except febrile seizures in childhood).
  • Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.
  • Other neurodegenerative diseases or dementias other than AD dementia.
  • Any other condition that, in the investigator's opinion, makes the subject unsuitable for the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Китай · 1 центр
  • Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07580703 · ELI-101-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗