NCT00884507已完成2 期
A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 389
- 主要终点
- Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
研究概览
简要总结
This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •adult patients, >/=50 years of age;
- •probable Alzheimer's disease;
- •MMSE score at screening of 13-22;
- •under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline;
- •not requiring nursing home care, but looked after by a caregiver/carer.
排除标准
- •dementia due to condition other than Alzheimer's disease;
- •other significant neurological disorder;
- •untreated/non-stabilized major depressive disorder;
- •bipolar disorder, schizophrenia, or any other serious psychiatric condition.
研究组 & 干预措施
RO5313534 15mg
Experimental
干预措施: RO5313534 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO5313534 1mg
Experimental
干预措施: RO5313534 (Drug)
RO5313534 5mg
Experimental
干预措施: RO5313534 (Drug)
结局指标
主要结局
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
时间窗: Week 24
次要结局
- CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview(At intervals up to week 24, then at week 28)
- AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.(At intervals to week 24, then at week 28)
研究者
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