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

A 24 Week, Prospective, Randomized, Parallel-group, Double-blind, Multi-center Study (ENA713DUS44) Comparing the Effects of Rivastigmine Patch 15 cm^2 vs. Rivastigmine Patch 5 cm^2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION) and a 24-week Open-label Extension to Study ENA713DUS44

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Rivastigmine 4.6 mg/24 h (5 cm^2)	Rivastigmine was supplied in a 5 cm\^2 patch which released 4.6 mg/24 h. Patches were changed daily.
DRUG	Rivastigmine 9.5 mg/24 h (10 cm^2)	Rivastigmine was supplied in a 10 cm\^2 patch which released 9.5 mg/24 h. Patches were changed daily.
DRUG	Rivastigmine 13.3 mg/24 h (15 cm^2)	Rivastigmine was supplied in a 15 cm\^2 patch which released 13.3 mg/24 h. Patches were changed daily.
DRUG	Placebo	Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2009-07-29
• Last updated: 2013-08-28
• Results posted: 2013-02-11

Locations

95 sites across 2 countries: United States, Puerto Rico