At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, 5-Week, Open-Label, Randomized, Multi-Center, Parallel-Group Study With a 20-Week, Open-Label Extension Evaluating the Tolerability and Safety of Switching From Donepezil to an Initial Dose of 5 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Rivastigmine 5 cm^2 transdermal patch and Rivastigmine 10 cm^2 transdermal patch for Alzheimer's Disease. Completed, enrolled 262 participants across 23 sites.
Detailed Summary
This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm\^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.
Study Details
Timeline
Interventions
Rivastigmine 5 cm\^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.
Rivastigmine 10 cm\^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.