Идёт набор NCT06947941
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
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, KarXT + KarX-EC Arm Matching Placebo.
- Кому может быть актуально
- Состояния в реестре: Alzheimer Disease, Psychosis. 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, Австралия, Канада, Япония, Великобритания
- 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 Psychosis Associated With Alzheimer's Disease
Обзор
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Вмешательства
- Препарат KarXT
Specified dose on specified days - Препарат KarX-EC
Specified dose on specified days - Препарат KarXT + KarX-EC Arm Matching Placebo
Specified dose on specified days
Первичные конечные точки
- Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score [Срок оценки: Up to approximately Week 14]
Вторичные конечные точки (12)
- Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score [Срок оценки: Up to approximately Week 14]
- Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score [Срок оценки: Up to approximately Week 14]
- Change From Baseline in NPI-C: Agitation Score [Срок оценки: Up to approximately Week 14]
- Change From Baseline in NPI-C Core Score: Caregiver Distress Scale [Срок оценки: Up to approximately Week 14]
- Responder Rate [Срок оценки: Up to approximately Week 14]
- Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score [Срок оценки: Up to approximately Week 14]
- Change From Baseline in CMAI Total Score [Срок оценки: Up to approximately Week 14]
- Number of Participants With Adverse Events (AEs) [Срок оценки: Up to approximately Week 14]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately Week 14]
- Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to approximately Week 14]
- Number of Participants With TEAEs Leading to Discontinuation [Срок оценки: Up to approximately Week 14]
- Number of Participants With Spontaneously Reported Procholinergic Symptoms [Срок оценки: Up to approximately Week 14]
Критерии участия
Критерии включения
- Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.
- Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
- Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Критерии исключения
- Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
- Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Participants must not have certain safety concerns, including certain laboratory test irregularities.
- 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
Центры проведения
Великобритания · 8 центров
- Local Institution - 0005 — Exeter
- Local Institution - 0023 — London
- Local Institution - 0015 — Oxford
- Local Institution - 0009 — Chertsey
- Local Institution - 0017 — Sheffield
- Local Institution - 0018 — Crowborough
- Local Institution - 0024 — London
- Local Institution - 0004 — Motherwell
США · 6 центров
- Gilbert Neurology Partners/CCT Research — Gilbert
- Inland Psychiatric Medical Group. — Chino
- Local Institution - 0001 — Naples
- Local Institution - 1401 — Naples
- Local Institution - 0029 — Cleveland
- Insight Clinical Trials LLC - Independence — Independence
Канада · 3 центра
- Local Institution - 0054 — Toronto
- Local Institution - 0027 — Whitby
- Local Institution - 0025 — Montreal
Япония · 3 центра
- Local Institution - 0040 — Suita
- Local Institution - 0035 — Nankoku-shi
- Local Institution - 0034 — Osaka
Австралия · 2 центра
- Local Institution - 0020 — Macquarie Park
- Local Institution - 0052 — Nedlands
Идентификаторы
NCT: NCT06947941 · CN012-0034 · 2025-521057-16 · U1111-1318-5718