A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— BETTER  

Official title:

A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047579
• Other study ID #: CENA713DIL01
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: February 22, 2017
• Start date: April 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.

• MMSE score of >10 and <26.

• Patients who were under ChE inhibitor treatment and experienced adverse events.

• Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.

Exclusion Criteria:

• Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.

• Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.

• History of allergy to topical products containing any of the constitution of the patches.

• Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.

• Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).

• Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine transdermal

Locations

Country	Name	City	State
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigational Site	Haifa
Israel	Novartis Investigative Site	Holon
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver questionnaire		12 weeks
Secondary	Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)		every visit

External Links

•   Online Library of the Joint Congress of European Neurology 2014. Ash E. May 31, 2014; 52213
•   Results for CENA713DIL01 from the Novartis Clinical Trials website