NCT06194799Enrolling By Invitation3 期
A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 752
- 试验地点
- 136
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has successfully completed ACP-204-006 study
- •Male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential
- •Subject has a designated study partner/caregiver
- •Subjects are able to complete all study visits with a study partner/caregiver
- •Signed inform consent form with a caregiver or legal representative
排除标准
- •Requires treatment with a medication prohibited by the protocol
- •Is in hospice and receiving end-of-life palliative care, or has become bedridden
- •Unstable clinically significant medical condition other than AD
- •Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study
- •Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
研究组 & 干预措施
ACP-204
Experimental
ACP-204 30mg or 60mg
干预措施: ACP-204 (Drug)
结局指标
主要结局
Treatment-emergent adverse events
时间窗: 52 Weeks
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.
次要结局
- Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score(52 Weeks)
研究者
研究点 (136)
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