Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease

Novartis262 enrolled

Overview

This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

262

Conditions

Alzheimer's Disease

Interventions

Rivastigmine 5 cm^2 transdermal patchDRUG

Rivastigmine 5 cm\^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.

Rivastigmine 10 cm^2 transdermal patchDRUG

Rivastigmine 10 cm\^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be at least 50 years of age; * Have a diagnosis of probable Alzheimer's Disease; * Have an MMSE score of \> or = 10 and \< or = 24; * Must have a caregiver who is able to attend all study visits; * Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months. Exclusion Criteria: * Have 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; * Have a history of malignancy of any organ system, treated or untreated, within the past 5 years; * Have a history within the past year or current diagnosis of cerebrovascular disease; * Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months; * Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease); * Digestive problems related to peptic ulcer; * Urinary obstruction or current severe urinary tract infection; * Abnormal thyroid function tests; * Low folate or Vitamin B12; * Have a disability that may prevent the patient from completing all study requirements; * Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch; Other protocol-defined inclusion/exclusion criteria may apply

Locations (23)

Dedicated Clinical Research

Sun City, Arizona, United States

Outcomes

Primary Outcomes

Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study

The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.

Time frame: Baseline through the end of the core phase of the study (Week 5)

Secondary Outcomes

Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study

A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study.

Time frame: Baseline through the end of study (25 weeks)

Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase

Time frame: From week 5 through the end of extension phase (25 weeks)

Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25

The CGIC is an assessment tool used by a skilled clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) "very much improved" to (4) "no change" to (7) "very much worse".

Data from ClinicalTrials.gov

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