Conditions: Alzheimer's Disease
Keywords: Alzheimer's rivastigmine transdermal safety randomized switch patch
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

Brief summary:
This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) intervention 2: Rivastigmine patch (9.5 mg/day) intervention 3: Rivastigmine capsules (6 mg to 12 mg/day)
Intervention descriptions: intervention 1: Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). intervention 2: Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). intervention 3: Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.

Protocol document: