NCT00622713

A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)

A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

Summary

This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Rivastigmine transdermal patch	The study treatment was delivered as a patch sizes 5 and 10 cm\^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm\^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm\^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm\^2.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-02-25
• Last updated: 2011-07-26
• Results posted: 2011-07-26

Locations

1 site across 1 country: France