NCT00428389

Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Rivastigmine 5 cm^2 transdermal patch	Rivastigmine 5 cm\^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours.
DRUG	Rivastigmine 10 cm^2 transdermal patch	Rivastigmine 10 cm\^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours.

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-01-30
• Last updated: 2014-06-11
• Results posted: 2011-06-27

Locations

23 sites across 1 country: United States