A Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study
研究概览
简要总结
This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV (Diagnostic & Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score > 10 and < 26
- •Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study
- •Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver
- •Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study.
排除标准
- •A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
- •Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
- •History of allergy to topical products containing vitamin E
- •Taken any of the following substances prior to randomization:
- •succinylcholine-type muscle relaxants during the previous 2 weeks
- •an investigational drug during the previous 4 weeks
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)
干预措施: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) (Drug)
Rivastigmine patch (9.5 mg/day)
干预措施: Rivastigmine patch (9.5 mg/day) (Drug)
Rivastigmine capsules (6 mg to 12 mg/day)
干预措施: Rivastigmine capsules (6 mg to 12 mg/day) (Drug)
结局指标
主要结局
Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study
时间窗: Baseline to end of study (Month 3)
Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).
次要结局
- Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.(Baseline to end of study (Month 3))
- Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)(Baseline to end of study (Month 3))
- Overall Caregiver Satisfaction With Treatment(At end of study (Month 3))
- Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3(Baseline to Month 1 and Month 3)
- Overall Patient Satisfaction With Treatment(At end of study (Month 3))