A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's disease
- •On Memantine
- •Caregiver who is willing to accompany the patient to all clinic visits
排除标准
- •Unstable medical illnesses or significant hepatic or renal disease
- •Other primary psychiatric or neurological disorders
研究组 & 干预措施
Dimebon
20 mg dimebon by mouth 3 times per day
干预措施: Dimebon (Drug)
Placebo
20 mg placebo by mouth 3 times per day
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil.
时间窗: up to 28 days
Treatment discontinuation due to adverse events, the frequency and severity of adverse events, and clinically significant changes in safety assessments (including physical examination findings, vital signs, laboratory values, and ECGs) in the dimebon group will be compared to those reported in the placebo group.
次要结局
- To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil.(up to 28 days)