EUCTR2017-001339-38-PL进行中（未招募）1 期
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of probable AD according to the 2011 NIA-AA working
- •groups criteria.
- •2. The patient has clinically significant, moderate/severe agitation at the
- •time of screening and for at least 2 weeks prior to baseline.
- •3. The diagnosis of agitation must meet the IPA provisional definition of agitation.
- •4. CGIS-Agitation score is = 4 (moderately ill) at Screening and Baseline.
- •5. MMSE score between 6 and 26 (inclusive) at Screening and Baseline.
- •6. Caregiver must be willing and able to comply with study procedures,including not administering any prohibited medications during the course of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 172
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 378
排除标准
- •1. Patient has dementia predominantly of non-Alzheimer's type (e.g.,
- •vascular dementia, frontotemporal dementia, Parkinson's disease,
- •substance-induced dementia).
- •2. Patients with symptoms of agitation that are not secondary to AD
- •(e.g., secondary to pain, other psychiatric disorder, or delirium).
- •3. Patients with myasthenia gravis (contraindication for quinidine).
研究者
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