NCT05980949招募中3 期
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Karuna Therapeutics, Inc., a Bristol Myers Squibb company833 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年7月11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
- 1,000
- 试验地点
- 833
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-
- •This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.
- •Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:
- •The subject's legally acceptable representative (LAR) must provide IC
- •The subject must provide informed assent
- •Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
排除标准
- •Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
- •Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
- •Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
KarXT
Experimental
Xanomeline and Trospium Chloride Capsules
干预措施: KarXT (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From initial dose through 14 days after the final dose (up to 54 weeks)
The number and percentage of participants with TEAEs will be determined
次要结局
- Incidence of serious TEAEs(From initial dose through 14 days after the final dose (up to 54 weeks))
- Incidence of TEAEs leading to withdrawal(From initial dose through 14 days after the final dose (up to 54 weeks))
研究者
研究点 (833)
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