Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 734
- 试验地点
- 107
- 主要终点
- Change in Cognition
研究概览
简要总结
To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).
详细描述
The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 60mg/day as adjunctive therapy to an acetylcholinesterase inhibitor (donepezil 10mg/day, rivastigmine at the patient's individual maintenance dose, or galantamine at the patient's individual maintenance dose), and a 4-week safety follow-up period following study completion or withdrawal from treatment. The dose could be decreased once during the study to 30mg/day if 60mg/day was not well tolerated in the opinion of the investigator. The dose could be increased again to 60mg/day, after which the dose was kept fixed for the remainder of the study. Dose changes were permitted until Week 12 (Visit 5).
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
- 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
- •The patient has a knowledgeable and reliable caregiver.
- •The patient is an outpatient.
- •The patient has probable AD.
- •The patient has mild to moderate AD.
- •Stable treatment with an AChEI.
- •The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.
- •The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.
排除标准
- •The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
- •The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
- •The patient has evidence of clinically significant disease.
- •The patient's current AChEI therapy is likely to be interrupted or discontinued during the study.
- •The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo adjunct to base treatment with an AChEI
干预措施: Placebo (Drug)
Idalopirdine 60 mg (or 30 mg)
Idalopirdine adjunct to base treatment with an AChEI
干预措施: Idalopirdine (Drug)
结局指标
主要结局
Change in Cognition
时间窗: Baseline and Week 24
Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score. The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).
次要结局
- Change in Global Impression(Baseline and Week 24)
- Change in Daily Functioning(Baseline and Week 24)
- Change in Individual Behavioural Disturbance Items(Baseline and Week 24)
- Change in Behavioural Disturbance(Baseline and Week 24)
- Clinical Improvement(Week 24)
- Clinical Worsening(Week 24)
- Change in Health-related Quality of Life (EQ-5D) Utility Score(Baseline and Week 24)
- Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline(Baseline and Week 24)
- Change in Cognitive Aspects of Mental Function(Baseline and Week 24)
- Change in Health-related Quality of Life (EQ-5D VAS)(Baseline and Week 24)