Идёт набор NCT07169578

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Фаза III С лечением Alzheimers 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: В протоколе указаны: Trontinemab, Placebo.
Кому может быть актуально: Состояния в реестре: Alzheimers Disease. 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: США, Аргентина, Бразилия, Канада, Китай +8
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 Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

Обзор

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Вмешательства

Препарат Trontinemab
Participants will receive IV trontinemab.
Другое Placebo
Participants will receive IV placebo.

Первичные конечные точки

Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [Срок оценки: Baseline - Week 72]

Вторичные конечные точки (12)

Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) [Срок оценки: Baseline - Week 72]
Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score [Срок оценки: Baseline - Week 72]
Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS) [Срок оценки: Baseline - Week 72]
Change from baseline through Week 72 in Mini-Mental State Examination (MMSE) [Срок оценки: Baseline - Week 72]
Change from baseline in CDR-SB [Срок оценки: Baseline up to but excluding Week 72]
Time to increase in Clinical Dementia Rating, Global Score (CDR-GS) [Срок оценки: Baseline - Week 72]
Percentage of participants with adverse events (AEs) [Срок оценки: Baseline - Week 72]
Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings [Срок оценки: Baseline - Week 72]
Percentage of participants with infusion-related reactions (IRR) [Срок оценки: Baseline - Week 72]
Percentage of participants with anti-drug antibodies (ADAs) to trontinemab [Срок оценки: Baseline - Week 72]
Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan [Срок оценки: Baseline - Week 72]
Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants [Срок оценки: Baseline - Week 72]

Критерии участия

Критерии включения

Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening
A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
Availability of a "study partner" as defined by the protocol

Критерии исключения

Any evidence of a condition other than AD that may affect cognition
History or presence of clinically significant cerebrovascular disease
History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
History or presence of clinically significant intracranial mass
MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI
Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение

Центры проведения

США · 35 центров

University of Alabama at Birmingham — Birmingham
Banner Sun Health Research Institute — Sun City
Irvine Center for Clinical Research — Irvine
Inglewood Clinicals — Los Angeles
UCSF - Memory and Aging Center — San Francisco
Syrentis Clinical Research — Santa Ana
K2 Medical Research - The Villages — Lady Lake
K2 Medical Research, LLC — Maitland
… и ещё 27 центров

Китай · 25 центров

The Affiliated Hospital of Xuzhou Medical University — Xuzhou
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Шанхай
Peking University First Hospital — Пекин
Beijing Friendship Hospital Affiliated of Capital University of Medical Science — Пекин
Beijing Tiantan Hospital,Capital Medical University — Пекин
Peking University Sixth Hospital — Пекин
The First Hospital of Jilin University — Changchun
West China Hospital - Sichuan University — Чэнду
… и ещё 17 центров

Германия · 13 центров