NCT07095465Enrolling By Invitation3 期
52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
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
- 126
- 试验地点
- 30
- 主要终点
- Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
研究概览
简要总结
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
详细描述
Study Website: https://illumerastudy.com/
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
- •Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
- •Can complete all study visits with a study partner/caregiver
- •Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
- •The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
- •The subject must provide written (if capable) informed assent per local regulations
- •If the subject is a female, she must be of nonchildbearing potential
- •If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug:
- •Refrain from donating sperm, AND
- •Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- •Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
排除标准
- •Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- •Is in hospice, is receiving end-of-life palliative care, or is bedridden
- •Has a heart rate <50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
- •Has a BMI <18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
- •Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either:
- •jeopardize the safe participation of the subject in this study; OR
- •interfere with the conduct or interpretation of safety or efficacy evaluations in the study
- •Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
- •Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
- •Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction
研究组 & 干预措施
ACP-204
Experimental
Initiation of treatment with ACP-204 at a dose of 30 mg once daily. During the trial, the dose may be adjusted, i.e. uptitration to 60 mg in case of suboptimal efficacy or subsequent down titration to 30 mg. Repeated titration steps are allowed.
干预措施: ACP-204 (Drug)
结局指标
主要结局
Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
研究点 (30)
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