An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,463
- 试验地点
- 258
- 主要终点
- Number of TEAEs in the OLEX-MEM
研究概览
简要总结
To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
详细描述
This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641).
Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641
- •For patients in the OLEX-MEM:
- •The patient has completed Visit 6 (Week 28) of the OLEX.
- •The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.
排除标准
- •The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
- •The patient has experienced seizures before Completion Visit in the lead-in study.
- •The patient has evidence of clinically significant disease.
- •The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
- •The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Idalopirdine (Lu AE58054) 60 mg
Idalopirdine 60 mg adjunct to 10 mg donepezil. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study.
干预措施: Idalopirdine 60 mg (Drug)
Idalopirdine 60 mg + memantine
Idalopirdine 60 mg as adjunct to 10 mg donepezil and memantine (patient's individualised maintenance dose, either immediate-release (IR) 20 mg/day (recommended target dose) or extended release (XR) 28 mg/day (recommended target dose). Memantine was administered to approximately 100 patients included in the OLEX-MEM. The dose of idalopirdine could be decreased from 60 mg to 30 mg if 60 mg was not well tolerated. The dose of donepezil was to be maintained throughout the study. The dose of memantine could be changed at any time throughout the study.
干预措施: Idalopirdine 60 mg (Drug)
结局指标
主要结局
Number of TEAEs in the OLEX-MEM
时间窗: From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).
Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX
时间窗: Baseline II (start of OLEX, week 0) to end of OLEX (week 28)
A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.
次要结局
- Change in Cognitive Aspects of Mental Function(Baseline III (start of OLEX-MEM, Week 28) to Week 52)
- Change in Cognition(Baseline II (start of OLEX, Week 0) to Week 28)
- Change in Behavioural Disturbance(Baseline II (start of OLEX, Week 0) to Week 28)
- Clinical Global Impression Score(Week 28)
- Change in Daily Functioning(Baseline II (start of OLEX, Week 0) to Week 28)