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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00731224
First received: August 5, 2008
Last updated: March 28, 2013
Last verified: March 2013

August 5, 2008
March 28, 2013
July 2008
October 2011   (final data collection date for primary outcome measure)
Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks. [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00731224 on ClinicalTrials.gov Archive Site
  • 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). [ Time Frame: At baseline, wk 12 and wk 24 ] [ Designated as safety issue: No ]
  • Patient compliance (drug accounting) [ Time Frame: During 24 weeks ] [ Designated as safety issue: No ]
  • 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.
  • Patient compliance (drug accounting) during 24 weeks
Not Provided
Not Provided
 
Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.
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.

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Rivastigmine transdermal patch
Experimental: 1
Intervention: Drug: Rivastigmine transdermal patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
October 2011
October 2011   (final data collection date for primary outcome measure)

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

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Turkey,   Korea, Republic of,   Malaysia,   Thailand
 
NCT00731224
CENA713DAU01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP