NCT00549601

Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

A Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)	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).
DRUG	Rivastigmine patch (9.5 mg/day)	Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
DRUG	Rivastigmine capsules (6 mg to 12 mg/day)	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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-10-26
• Last updated: 2011-03-24
• Results posted: 2011-03-24

Locations

1 site across 1 country: Spain