An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Novartis0 个研究点目标入组 868 人开始时间: 2003年2月1日最近更新: 2017年2月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 868
主要终点: Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease

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 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who fulfilled the inclusion and

排除标准

•as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

结局指标

主要结局

Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment

次要结局

Change in activities of daily living from baseline at week 52
Change in behavioral symptoms from baseline at week 52
Change in executive function from baseline at week 52
Change in cognition from baseline (week 24 of the double blind phase) at week 52
Clinical global impression of change from baseline at week 52

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

3 期

Rivastigmine Capsules in Patients With Probable Vascular DementiaVascular Dementia

NCT00130338Novartis521

已完成

3 期

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)Progressive Familial Intrahepatic Cholestasis (PFIC)

NCT04185363Mirum Pharmaceuticals, Inc.84

招募中

3 期

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)Lupus Nephritis

NCT06711887Novartis Pharmaceuticals348

已完成

2 期

Open-Label Extension (OLE) Study for Safety and Efficacy of Velneperit (S-2367) in Obese SubjectsObesity

NCT00788528Shionogi766

已完成

3 期

A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With HypertensionHypertension

NCT00457626Novartis Pharmaceuticals66