Phase IV study for Rivastigmine Patch with 1-step Titratio

Phase 4

Completed

• Conditions: Alzheimer's Disease

• Registration Number: JPRN-jRCT1080223175
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-21
• Study Completion: 2018-06-29
• Results First Posted: 2019-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

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.

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified