drugset / Trial / NCT00948766

Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44

NCT00948766

Phase 4 Completed 716 enrolled Novartis
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

Timeline

Start
2009-07
Primary completion
2012-01
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivastigmine Small molecule 4.6 mg Other
Subject Rivastigmine Small molecule 9.5 mg Other
Subject Rivastigmine Small molecule 13.3 mg Other

Indications