Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.

Alzheimer's Disease Clinical Trial

— CARE  

Official title:

A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731224
• Other study ID #: CENA713DAU01
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2008
• Last updated: March 24, 2017
• Start date: July 2008
• Est. completion date: October 2011

Study information

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

Clinical Trial Summary

This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;

• MMSE score of =10 and = 26;

Exclusion Criteria:

• Bradycardia (beats per minute less than 50)

• Body weight less than 40 kg;

• Hypersensitivity to cholinesterase inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine transdermal patch

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Ballarat	Victoria
Australia	Novartis Investigative Site	Chemside	Queensland
Australia	Novartis Investigative Site	East Gosford	New South Wales
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Gosford	New South Wales
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Hornsby	New South Wales
Australia	Novartis Investigative Site	Nedlands
Australia	Novartis Investigative Site	Randwick	New South Wales
Australia	Novartis Investigative Site	Woodville	South Australia
Korea, Republic of	Novartis Investigative Site	Bundang	Seongnam
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Malaysia	Novartis Investigative Site	Ipoh	Perak
Malaysia	Novartis Investigative Site	Johor Bahru	Johor
Malaysia	Novartis Investigative Site	Kuala Lumpur	Selangor
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Seremban	Negeri Sembilan
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Turkey	Novartis Investigative Site	Altunizade
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Atakum / Samsun
Turkey	Novartis Investigative Site	Bursa
Turkey	Novartis Investigative Site	Emek / Ankara
Turkey	Novartis Investigative Site	Etlik / Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kocaeli
Turkey	Novartis Investigative Site	Konya
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Meselik / Eskisehir
Turkey	Novartis Investigative Site	Talas / Kayseri
Turkey	Novartis Investigative Site	Uskudar / Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Korea, Republic of,  Malaysia,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.		At week 24
Secondary	Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).		At baseline, wk 12 and wk 24
Secondary	Patient compliance (drug accounting)		During 24 weeks

External Links

•   Results for CENA713DAU01 from the Novartis Clinical Trials website