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

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 1)

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 reflect significant pathology other than AD or 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

США · 28 центров

• Healthy Brain Clinic — Long Beach
• Anderson Clinical Research — Redlands
• Mountain Neurological Research Center — Basalt
• Georgetown University Medical Center — Washington D.C.
• JEM Research Institute — Atlantis
• VIN-Julie Schwartzbard — Aventura
• Merritt Island Medical Research, LLC — Merritt Island
• Renstar Medical Research — Ocala
• … и ещё 20 центров

Канада · 8 центров

• OCT Research ULC — Kelowna
• Richmond Clinical Trials — Richmond
• Centricity Research Halifax Multispecialty — Halifax
• Ottawa Memory Clinic — Ottawa
• Toronto Memory Program — Toronto
• MoCA Research and Innovation Inc. — Greenfield Park
• Diex Recherche Victoriaville — Victoriaville
• ALPHA Recherche Clinique — Québec

Чехия · 7 центров

• Neuro Health Centrum — Brno
• AGE Centrum — Olomouc
• A-Shine — Pilsen
• Local Institution - 0224 — Prague
• Neuropsychiatrie — Prague
• Local Institution - 0222 — Prague
• Vestra Clinics — Rychnov nad Kněžnou

Франция · 7 центров

• Local Institution - 0295 — Nice
• Local Institution - 0289 — Toulouse
• Local Institution - 0290 — Rouen
• Local Institution - 0291 — Montpellier
• Local Institution - 0299 — Reims
• Local Institution - 0293 — Villeurbanne
• Local Institution - 0294 — Dijon

South Korea · 7 центров

Список центров уточняется — проверьте первичный протокол.

Германия · 6 центров

• Universitätsklinikum Münster - Albert Schweitzer Campus — Münster
• Universitätsmedizin Johannes Gutenberg Universität Mainz — Mainz
• Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) — Berlin
• Local Institution - 0277 — Bremen
• Local Institution - 0275 — Hamburg
• TUM Klinikum — Munich

Испания · 6 центров

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Аргентина · 5 центров

• Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) — Buenos Aires
• Local Institution - 0271 — Buenos Aires
• Fundación Lennox - Instituto Modelo de Neurología — Córdoba
• Sanatorio Morra S.A. — Córdoba
• Instituto Kremer — Córdoba

Австралия · 5 центров

• Southern Neurology — Kogarah
• KARA Institute for Neurological Diseases — Macquarie Park
• NeuroCentrix — Carlton
• Neurodegenerative Disorders Research — Perth
• St Vincent's Hospital Sydney Limited — Darlinghurst

Индия · 5 центров

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Румыния · 5 центров

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Бразилия · 4 центра

• Local Institution - 0168 — Brasília
• Instituto de Neurologia de Curitiba — Curitiba
• Local Institution - 0266 — Aracaju
• Hospital das Clinicas FMUSP — São Paulo

Чили · 4 центра

• Local Institution - 0094 — Santiago
• Local Institution - 0089 — Santiago
• Local Institution - 0241 — Santiago
• Local Institution - 0230 — Antofagasta

Греция · 4 центра

• University General Hospital of Alexandroupoli — Alexandroupoli
• Local Institution - 0256 — Athens
• Aiginiteio University Hospital — Athens
• … и ещё 1 центр

Италия · 4 центра

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Польша · 4 центра

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Хорватия · 3 центра

• Local Institution - 0215 — Zagreb
• Poliklinika Neuron — Zagreb
• Klinika za psihijatriju "Vrapče" — Zagreb

Нидерланды · 3 центра

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Пуэрто-Рико · 1 центр

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Идентификаторы

NCT: NCT06976216 · CN012-0051 · 2025-520746-30 · U1111-1317-4462

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗