2024-516363-92-00招募中3 期
CN0120056: 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 (ADEPT-4)
Bristol-Myers Squibb Services Unlimited Company62 个研究点 分布在 11 个国家目标入组 93 人开始时间: 2025年3月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 62
- 主要终点
- The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.
研究概览
简要总结
The main objectives of the trial are to evaluate the efficacy of KarXT compared with placebo in the treatment of psychosis in participants with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C):Hallucinations and Delusions (H+D) score
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients who are 55-90 years old
- •Diagnosed with AD based on the 2024 National Institute on Aging – Alzheimer’s Association criteria with AD biomarker confirmation
- •Participants who 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 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.
- •History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- •Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
结局指标
主要结局
The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.
The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.
次要结局
- The key secondary endpoint is the change from Baseline to End of Treatment on CGI-S score.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (62)
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