A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy,Safety and Tolerability of Rivastigmine Patchwith 1-step Titration in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10 - 23) Switched Directly From Cholinesterase Inhibitors (Donepezil, Galantamine)

ovartis Pharma K.K.0 个研究点目标入组 118 人开始时间: 2016年4月21日最近更新: 2023年10月17日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 118

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

This study showed that switching to rivastigmine patch with 1-step titration was effective in suppressing further progression of cognitive decline or worsening of dementia symptoms in patients with mild to moderate AD who did not respond to ChEIs (donepezil or galantamine). Overall, the rivastigmine patch was efficacious, well-tolerated and the safety profile observed in this study was as per the safety profile reported in other clinical studies with rivastigmine patch treatment.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 50age old 至 <= 85age old（—）
性别: All

入选标准

•Outpatient status at baseline.
•-A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria.
•-A clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
•-Patients with MMSE score of >= 10 and <= 23 at screening and baseline
•-Patients are currently on the oral monotherapy (donepezil, 5 mg), or galantamine (16-24 mg) for 4 weeks prior to baseline visit.
•-Patients who failed to receive enough treatment benefit from the previous treatment can be defined if the patients meet at least one of following conditions at screening and baseline (multiple choices allowed)
•-Patients who declined >= 2 points of MMSE despite of treatment of other oral Cholinesterase (ChE) inhibitors in initial 3-month.
•-Patients who declined >= 2 points of MMSE in last 6 months with other oral ChE inhibitors (ChEI).
•-Patients who show marked worsening of BPSD, or ADL (can be defined by 1state progression of FAST) judged by a physician despite of treatment of other oral ChE inhibitors in initial 3-month or last 6-month with other oral ChE inhibitors
•-Patients having difficulties being treated orally with ChEIs (donepezil or galantamine) by physician's judgement.
•-Poor compliance or adverse event except GI symptoms
•-Patients with swallowing difficulties.

排除标准

•-Any medical or neurological condition other than AD that could explain the patient's dementia (e.g., abnormal thyroid function tests, vitamin B12 or folate deficiency, posttraumatic conditions, syphilis, head injury, Huntington's disease, Parkinson's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor) at baseline
•-Any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder
•-Current diagnosis of an active skin lesion/disorder
•-Patients with a history of hypersensitivity to any ingredients of rivastigmine or carbamate derivatives
•-An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk

研究者

发起方

ovartis Pharma K.K.

相似试验

已完成

4 期

Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease

NCT00549601Novartis142

已完成

3 期

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive DeclineAlzheimer Disease

NCT00506415Novartis Pharmaceuticals1,584

已完成

4 期

Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase InhibitorsAlzheimer's Disease

NCT01529619Novartis Pharmaceuticals52

已完成

4 期

NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Moderate Alzheimer's Patients.Mild to Moderate Alzheimer's Disease

NCT02703636Novartis Pharmaceuticals118

已完成

4 期

Exelon Patch and Combination With Memantine Comparative TrialAlzheimer's Disease

NCT01025466Inha University Hospital206