A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 291
- 试验地点
- 82
- 主要终点
- Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).
研究概览
简要总结
Primary Objective:
- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy
Secondary Objectives:
- To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
- To assess the safety/tolerability of SAR110894;
- To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
- To explore caregiver time consumption and distress changes.
详细描述
The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:
- Screening period: up to 4 weeks,
- Treatment period: 24 weeks,
- Follow-up period: 10 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR110894 - 0.5 mg
SAR110894, 0.5 mg once daily along with Donepezil.
干预措施: SAR110894 (Drug)
SAR110894 - 0.5 mg
SAR110894, 0.5 mg once daily along with Donepezil.
干预措施: Donepezil (Drug)
SAR110894 - 2 mg
SAR110894, 2 mg once daily along with Donepezil.
干预措施: SAR110894 (Drug)
SAR110894 - 2 mg
SAR110894, 2 mg once daily along with Donepezil.
干预措施: Donepezil (Drug)
SAR110894 - 5 mg
SAR110894, 5 mg once daily along with Donepezil.
干预措施: SAR110894 (Drug)
SAR110894 - 5 mg
SAR110894, 5 mg once daily along with Donepezil.
干预措施: Donepezil (Drug)
Placebo
Placebo (for SAR110894) once daily along with Donepezil.
干预措施: placebo (for SAR110894) (Drug)
Placebo
Placebo (for SAR110894) once daily along with Donepezil.
干预措施: Donepezil (Drug)
结局指标
主要结局
Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).
时间窗: Week 4, 12, and 24
次要结局
- Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score(Week 4, 12, and 24)
- Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")(Week 4, 12, and 24)
- Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment(Week 4, 12, and 24)
- Change from baseline in the Mini Mental State Examination (MMSE) total score(Week 4, 12, and 24)