Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Phase 3
Completed
- Conditions
- Dementia, Alzheimer TypeAlzheimer's Disease
- Registration Number
- NCT00099242
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1040
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in cognition from baseline at week 24 Global clinical impression of change from baseline at week 24
- Secondary Outcome Measures
Name Time Method Change from baseline at week 24 in activities of daily living Change from baseline at week 24 in global cognitive testing Change from baseline at week 24 in behavioral symptoms Change from baseline at week 24 in executive function Change from baseline at week 24 in attention