Conditions: Alzheimer Disease
Keywords: Alzheimer's Patch Cognitive Decline
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1584
Healthy volunteers: no

Brief summary:
The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.

Detailed description:

Arms:
arm 1: Rivastigmine 5 cm\^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm\^2 transdermal patch once a day from week 4 to week 24, 36 or 48. arm 2: Rivastigmine transdermal patch 10 cm\^2 and placebo to rivastigmine 15 cm\^2 once daily for 48 weeks during the double blind period. arm 3: Rivastigmine transdermal patch 15 cm\^2 and placebo to rivastigmine 10 cm\^2 once daily for 48 weeks during double blind period. arm 4: Rivastigmine 10 cm\^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.

Interventions: intervention 1: Rivastigmine 5 cm^2 intervention 2: Rivastigmine 10 cm^2 intervention 3: Rivastigmine 15 cm^2 intervention 4: Placebo to 15 cm^2 patch intervention 5: Placebo to 10 cm^2 patch
Intervention descriptions: intervention 1: 5 cm\^2 transdermal patch intervention 2: 10 cm\^2 transdermal patch. intervention 3: 15 cm\^2 transdermal patch. intervention 4: Placebo of rivastigmine transdermal patch 15 cm\^2. intervention 5: Placebo of rivastigmine transdermal patch 10 cm\^2.

Protocol document: