NCT07029581招募中2 期
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety 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
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 79
- 主要终点
- Change from Baseline in SAPS-LBDP total score at Week 6
研究概览
简要总结
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
详细描述
Study Website: https://illumerastudy.com/
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
- •Can 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 must provide written informed consent.
- •The subject must provide written (if capable) informed assent per local regulations.
- •Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).
- •Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association
排除标准
- •Is in hospice, is receiving end-of-life palliative care, or is bedridden
- •Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia
- •Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
- •Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures
- •Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT
研究组 & 干预措施
ACP-204 30 mg
Experimental
ACP-204 dose of 30 mg once daily
干预措施: ACP-204 (Drug)
Placebo
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
ACP-204 60 mg
Experimental
ACP-204 dose of 60 mg once daily
干预措施: ACP-204 (Drug)
结局指标
主要结局
Change from Baseline in SAPS-LBDP total score at Week 6
时间窗: 6 weeks
Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6
次要结局
未报告次要终点
研究者
研究点 (79)
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