A prospective, 16 week, phase IV study to evaluate safety, tolerability and effectiveness in patients with severe dementia of the Alzheimer’s type exposed to rivastigmine (Exelon)15cm2 transdermal patch
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 12
- 主要终点
- To obtain safety data in patients with severe dementia of the Alzheimer’s type treated with rivastigmine 27 mg -15 cm2 transdermal patch
研究概览
简要总结
Thepresent phase IV study is mandated byIndian health authority (HA) as a part of conditional approval to marketauthorization of rivastigmine 27 mg -15 cm2 transdermal patch for treatment ofsevere dementia secondary to Alzheimer’s disease (AD). The HA mandated phase IVstudy in their approval letter. Due to non- availability of Indian data forrivastigmine 27 mg -15 cm2 transdermal patch in severe dementia secondary toAlzheimer’s disease (AD) patients, marketing authorization of the same has beengranted condition to phase IV study. As per HA letter, interventional study isto be conducted.
Thus the present 16 week study will beconducted to evaluate safety, tolerability andeffectiveness in patients with severe dementia of the Alzheimer’s type exposed torivastigmine 27 mg -15 cm2 transdermal patch as mandated by HA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate in the study by providing written informed consent.
- •Patients diagnosed with severe dementia secondary to Alzheimer’s disease (AD) 3)Patient’s prescribed with rivastigmine 27mg -15 cm2 transdermal patch as per discretion of treating physician.
排除标准
- •Contraindication as per PI 2)Patients simultaneously participating in other studies.
结局指标
主要结局
To obtain safety data in patients with severe dementia of the Alzheimer’s type treated with rivastigmine 27 mg -15 cm2 transdermal patch
时间窗: Overall study period (from FPFV to LPLV)
次要结局
- 1)To assess patients compliance to study medication(2)To assess the skin tolerability)