Alzheimer's Disease, Dementia, Alzheimer Type
Conditions
Keywords
Alzheimer's Disease, Dementia
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.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cognition from baseline at week 24 | — |
| Global clinical impression of change from baseline at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at week 24 in global cognitive testing | — |
| Change from baseline at week 24 in activities of daily living | — |
| Change from baseline at week 24 in attention | — |
| Change from baseline at week 24 in executive function | — |
| Change from baseline at week 24 in behavioral symptoms | — |
Countries
Chile, Czechia, Denmark, Finland, Germany, Guatemala, Israel, Italy, Mexico, Norway, Peru, Poland, Portugal, Puerto Rico, Russia, Slovakia, South Korea, Sweden, Taiwan, United States, Venezuela
Outcome results
None listed