A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (Mini-Mental State Examination (MMSE) 10-20)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).
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 85 Years（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
Rivastigmine patch
Once-daily target patch size 10 cm²
干预措施: Rivastigmine Patch (Drug)
Rivastigmine patch
Once-daily target patch size 10 cm²
干预措施: Placebo to Rivastigmine capsules (Drug)
Rivastigmine capsules
Twice-daily target dose of 6 mg oral capsule
干预措施: Rivastigmine Capsules (Drug)
Rivastigmine capsules
Twice-daily target dose of 6 mg oral capsule
干预措施: Placebo to Rivastigmine patch (Drug)
结局指标
主要结局
Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
时间窗: Change at 24 weeks
The Alzheimer's Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.
次要结局
- Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)(Change at 24 weeks)
- Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score(Change at 24 weeks)
- Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score(Change at 24 weeks)
- Change From Baseline in Mini-Mental State Examination (MMSE) Total Score(Change at 24 weeks)