Идёт набор NCT06976203

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

Фаза III С лечением 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: В протоколе указаны: KarXT, KarX-EC, Placebo.
Кому может быть актуально: Состояния в реестре: Alzheimer's Disease. Базовые параметры: 60 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: США, Аргентина, Австралия, Бразилия, Финляндия +12
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 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)

Обзор

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Вмешательства

Препарат KarXT
Specified dose on specified days
Препарат KarX-EC
Specified dose on specified days
Другое Placebo
Specified dose on specified days

Первичные конечные точки

Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) [Срок оценки: At week 24]
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) [Срок оценки: At week 24]

Вторичные конечные точки (12)

Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) [Срок оценки: At week 24]
Change from baseline in neuro psychiatric inventory (NPI) total score [Срок оценки: At week 24]
Number of participants with adverse events (AEs) [Срок оценки: At week 24]
Number of participants with serious adverse events (SAEs) [Срок оценки: At week 24]
Number of participants with adverse event of special interest (AESIs) [Срок оценки: At week 24]
Number of participants with AEs leading to study intervention discontinuation [Срок оценки: At week 24]
Number of participants with AEs leading to study discontinuation [Срок оценки: At week 24]
Number of participants with AEs leading to death [Срок оценки: At week 24]
Number of participants with clinically significant changes in vital signs [Срок оценки: At week 24]
Number of participants with clinically significant changes in electrocardiogram (ECG) tests [Срок оценки: At week 24]
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests [Срок оценки: At week 24]
Number of participants with clinically significant changes in weight [Срок оценки: At week 24]

Критерии участия

Критерии включения

Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

Критерии исключения

Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of <50 mL/min), and unstable hypertension or tachycardia.

Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
Other protocol-defined Inclusion/Exclusion criteria apply.

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: Двойное слепое
Основная цель: Лечение

Центры проведения

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Neuropsychiatric Research Center of Southwest Florida — Fort Myers
Local Institution - 0086 — Hallandale
… и ещё 22 центра

Япония · 15 центров

Inage Neurology and Memory Clinic — Inage
Local Institution - 0123 — Matsudo
Imon Yukari Neurology Clinic — Hiroshima
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Франция · 14 центров

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
Local Institution - 0128 — Tours
Centre Hospitalier Universitaire Toulouse - Cité de la Santé — Toulouse
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro — Lille
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou — Rennes
Local Institution - 0127 — Saint-Herblain
Centre Hospitalier Universitaire Régional de Nancy — Nancy
Hospices Civils de Lyon - Hôpital Pierre Wertheimer — Bron
… и ещё 6 центров

Великобритания · 8 центров