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

Novartis Pharmaceuticals52 enrolled

Overview

This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase Inhibitors.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

Rivastigmine transdermal patchDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria * A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria * An MMSE score of \> or = 10 and \< or = 23 * Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit * Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as: * Inadequate compliance with the ChE inhibitors at screening and baseline * Presence of caregiver's burden for administering drugs orally at screening and baseline * Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline * Patients with swallowing difficulties at screening and baseline Exclusion Criteria: * A current DSM-IV diagnosis of major depression * Taken rivastigmine in the past * A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined inclusion/exclusion criteria may apply

Locations (11)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Miyoshi, Hiroshima, Japan

Outcomes

Primary Outcomes

Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J cog)

The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.

Time frame: Baseline and Week 24

Secondary Outcomes

Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug

Adverse Events: An adverse event is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug.

Time frame: Week 24

Change From Baseline in Disability Assessment for Dementia (DAD)

The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.

Time frame: Baseline and Week 24

Change From Baseline in Mini-Mental State Examination (MMSE)

The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.

Time frame: Baseline and Week 24

Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.