Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring rivastigmine,Alzheimer's Disease, transdermal patch
Eligibility Criteria
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 = 20
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
Other protocol-defined inclusion/exclusion criteria may apply
Extension Phase Eligibility Criteria
Inclusion Criteria:
- Patients who have completed the Double-blind Treatment Phase on study medication
Exclusion Criteria
- Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
rivastigmine 5 cm^2
Rivastigmine 10 cm^2
Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 patch for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.