An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219232
• Other study ID #: CENA713D2320E1
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: February 21, 2017
• Start date: February 2003
• Est. completion date: July 2006

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine Transdermal Patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

References & Publications (1)

Grossberg G, Sadowsky C, Fröstl H, Frölich L, Nagel J, Tekin S, Zechner S, Ros J, Orgogozo JM. Safety and tolerability of the rivastigmine patch: results of a 28-week open-label extension. Alzheimer Dis Assoc Disord. 2009 Apr-Jun;23(2):158-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment
Secondary	Change in cognition from baseline (week 24 of the double blind phase) at week 52
Secondary	Clinical global impression of change from baseline at week 52
Secondary	Change in activities of daily living from baseline at week 52
Secondary	Change in behavioral symptoms from baseline at week 52
Secondary	Change in executive function from baseline at week 52

External Links

•   Results for CENA713D2320E1 from the Novartis Clinical Trials website