Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Novartis Pharmaceuticals1,040 enrolled

Overview

The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,040

Conditions

Alzheimer's Disease Dementia, Alzheimer Type

Interventions

rivastigmine transdermal patchDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of dementia of the Alzheimer's type * Males, and females who are surgically sterile or one year postmenopausal * A primary caregiver willing to accept responsibility for supervising the treatment Exclusion Criteria: * Any condition (other than Alzheimer's) that could explain patient's dementia * An advanced, severe or unstable disease that may put the patient at special risk * Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

Locations (75)

Outcomes

Primary Outcomes

Change in cognition from baseline at week 24

Global clinical impression of change from baseline at week 24

Secondary Outcomes

Change from baseline at week 24 in activities of daily living

Change from baseline at week 24 in behavioral symptoms

Change from baseline at week 24 in global cognitive testing

Change from baseline at week 24 in executive function

Change from baseline at week 24 in attention

Data from ClinicalTrials.gov

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Unnamed facility

Orange, California, United States

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San Francisco, California, United States

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Boca Raton, Florida, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Port Charlotte, Florida, United States

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West Palm Beach, Florida, United States

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Snellville, Georgia, United States

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St Louis, Missouri, United States

...and 65 more locations