2024-517388-22-00招募中3 期
Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants with Alzheimer’s Disease Dementia
Exciva GmbH77 个研究点 分布在 6 个国家目标入组 222 人开始时间: 2026年5月1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
- 222
- 试验地点
- 77
- 主要终点
- Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory total score
研究概览
简要总结
To evaluate the therapeutic change from baseline of EXV-802 compared with placebo in the treatment of agitation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker, or with a wheelchair.
- •A previously established diagnosis of AD dementia.
- •The participant meets definition for agitation which require treatment with medicines.
- •The severity of agitation is at least moderate.
排除标准
- •The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.
- •The participant has symptoms of agitation that are due to psychiatric conditions other than AD dementia.
- •The participant has a history of uncontrolled seizures or a history of epilepsy.
- •The participant lacks a caregiver or support person who attends regularly to the participants’ needs.
研究组 & 干预措施
EXV-802
Test
干预措施: EXV-802 (Drug)
Matching Placebo
Placebo
干预措施: Matching Placebo (Drug)
EXV-801
Test
干预措施: EXV-801 (Drug)
结局指标
主要结局
Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory total score
Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory total score
次要结局
- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score, as related to symptoms of agitation.
- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Caregiver Distress total score for agitation and aggression.
- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Irritability / Lability score.
- EXV-802: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in the NPI-C Sleep Disorders score.
- EXV-802: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: • Mini‐Mental State Examination (MMSE) • Columbia Suicide Severity Rating Scale (C-SSRS) score • Clinical laboratory values • Vital signs • Electrocardiograms (ECGs) • Physical examination findings
- EXV-801: Difference between active and placebo as measured by changes from baseline to endpoint (Week 6) in CMAI, CGI-S, NPI-C, exploratory PD markers (BDNF), and blood-based biomarkers (analysis limited to descriptive statistics, including the effect size).
- EXV-801: Difference between active and placebo in frequency and severity of adverse events and clinically relevant changes in relevant safety endpoints e.g.: • Mini‐Mental State Examination (MMSE) • Columbia Suicide Severity Rating Scale (C-SSRS) score • Clinical laboratory values • Vital signs • Electrocardiograms (ECGs) • Physical examination findings
研究者
Chief Scientific Officer
Scientific
Exciva GmbH
研究点 (77)
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