Идёт набор NCT07011732

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)

Фаза III С лечением Alzheimer 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: Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo.
Кому может быть актуально: Состояния в реестре: Alzheimer 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: США, Аргентина, Бразилия, Болгария, Канада +10
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 Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Обзор

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Вмешательства

Препарат Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Препарат Xanomeline Enteric Capsule
Specified dose on specified days
Препарат Placebo
Specified dose on specified days

Первичные конечные точки

Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14 [Срок оценки: At Week 14]

Вторичные конечные точки (12)

Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14 [Срок оценки: At Week 14]
Change from baseline on the CMAI-IPA Domains at Week 14 [Срок оценки: At Week 14]
Change from baseline on the CMAI Total Score at Week 14 [Срок оценки: At Week 14]
Number of participants with Occurrence of Response at Week 14 [Срок оценки: At Week 14]
Change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14 [Срок оценки: At Week 14]
Number of participants with Adverse Events (AEs) [Срок оценки: Up to Week 18]
Number of participants with Treatment Emergent AEs (TEAEs) [Срок оценки: Up to Week 18]
Number of participants with Serious AEs (SAEs) [Срок оценки: Up to Week 18]
Number of participants with AEs leading to study drug withdrawal [Срок оценки: Up to Week 14]
Number of deaths [Срок оценки: Up to Week 18]
Number of participants with AEs of Special Interest (AESIs) [Срок оценки: Up to Week 18]
Barnes Akathisia Rating Scale (BARS) [Срок оценки: Up to Week 14]

Критерии участия

Критерии включения

\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.

ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.

B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:

Amyloid PET.
Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.

Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).
Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:

i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.

History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).

Критерии исключения

\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.

ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.

iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.

\- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).

A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.

B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).

C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).

\- 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: Четверное слепое
Основная цель: Лечение

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