NCT06585787招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
Karuna Therapeutics, Inc., a Bristol Myers Squibb company295 个研究点 分布在 7 个国家目标入组 406 人开始时间: 2024年9月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 406
- 试验地点
- 295
- 主要终点
- Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- •Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
- •Patient 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.
- •Patient 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).
排除标准
- •- Patients will not be able to participate if they have:
- •i) 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.
- •ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- •iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
- •* Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Placebo
Experimental
干预措施: Placebo (Drug)
KarXT
Experimental
干预措施: KarXT (Drug)
结局指标
主要结局
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
时间窗: Up to Week 14
次要结局
- Change from baseline in NPI-C Core score: Aggression Domain(Up to Week 14)
- Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale(Up to Week 14)
- Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain(Up to Week 14)
- Change from baseline in NPI-C Core score: Delusion Domain(Up to Week 14)
- Change from baseline in NPI-C Core score: Agitation Domain(Up to Week 14)
- Change from baseline in NPI-C Agitation score(Up to Week 14)
- Change from baseline in NPI-C Core score: Caregiver Distress Scale(Up to Week 14)
- Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score(Up to Week 14)
- Number of participants with Adverse Events (AEs)(Up to Week 14)
- Number of participants with Treatment-Emergent Adverse Events (TEAEs)(Up to Week 14)
- Number of participants with Serious Adverse Events (SAEs)(Up to Week 14)
- Number of participants with TEAEs leading to study withdrawal(Up to Week 14)
- Number of participants with procholinergic symptoms(Up to Week 14)
- Number of participants with anticholinergic symptoms(Up to Week 14)
- Number of participants with AEs of Special Interest (AESIs)(Up to Week 14)
- Barnes Akathisia Rating Scale (BARS) Score(Up to Week 14)
- Abnormal Involuntary Movement Scale (AIMS) Score(Up to Week 14)
- Body Weight(Up to Week 14)
- Body Mass Index (BMI)(Up to Week 14)
- Number of participants with vital sign abnormalities(Up to Week 14)
- Number of participants with clinical laboratory abnormalities(Up to Week 14)
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities(Up to Week 14)
- Cognition as assessed by the Mini-Mental State Examination (MMSE)(Up to Week 14)
- Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)(Up to Week 14)
- International Prostate Symptom Score (IPSS)(Up to Week 14)
- Number of participants with suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to Week 14)
研究者
研究点 (295)
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