Conditions: Alzheimer's Disease
Keywords: Alzheimer's Rivastigmine Patch Dementia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 501
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).

Detailed description:

Arms:
arm 1: Once-daily target patch size 10 cm² arm 2: Twice-daily target dose of 6 mg oral capsule

Interventions: intervention 1: Rivastigmine Patch intervention 2: Rivastigmine Capsules intervention 3: Placebo to Rivastigmine patch intervention 4: Placebo to Rivastigmine capsules
Intervention descriptions: intervention 1: Once-daily target patch size 10 cm² intervention 2: Twice-daily target dose of 6 mg oral capsule intervention 3: Matching placebo to Rivastigmine patch intervention 4: matching Placebo to Rivastigmine capsules

Protocol document: