A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01399125
First received: July 19, 2011
Last updated: June 24, 2013
Last verified: June 2013

July 19, 2011
June 24, 2013
July 2011
May 2013   (final data collection date for primary outcome measure)
Change from baseline on cognition, assessed by the ADAS-Cog [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
ADAS-Cog Measure: Efficacy ADAS-Cog Measure: Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01399125 on ClinicalTrials.gov Archive Site
  • Change from baseline in global functioning, assessed by the ADCS-CGIC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in caregiver-based activities of daily living (ADL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in behavioral symptoms, assessed by the NPI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in global cognitive function, assessed by the MMSE [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Assess the safety and tolerability of Rivastigmine with respect to adverse events, serious adverse events, nausea and vomiting, application site reactions, changes in safety evaluations, such as vital signs, ECG and laboratory parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • ADCS-CGIC Measure: Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • ADCS-ADL Measure: Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • NPI Measure: Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • MMSE Measure: Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • AE's - Labs - ECGs - application site reactions Measure: Safety [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (Mini-Mental State Examination (MMSE) 10-20)

The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Rivastigmine Patch
  • Drug: Rivastigmine Capsules
  • Experimental: Rivastigmine Patch (target size 10 cm²)
    Intervention: Drug: Rivastigmine Patch
  • Active Comparator: Rivastigmine capsules (target dose of 6.0 mg bid)
    Intervention: Drug: Rivastigmine Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • have a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria;
  • have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria.
  • have a brain scan (magnetic resonance imaging (MRI) or computed tomography (CT)) consistent with the diagnosis of AD. The brain scan must have been performed within one year prior to randomization;
  • have an MMSE score of ≥ 10 and ≤ 20;
  • have sufficient education to have been able to read, write, and communicate effectively during the premorbid state;
  • be residing with someone in the community throughout the study or, if living alone, in contact with the primary caregiver everyday;

Exclusion criteria:

  • have an advanced, severe, progressive, or unstable infectious, metabolic, immune, endocrinologic, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological condition that may interfere with efficacy and safety assessments or put the patient at special risk;
  • have a history or current diagnosis of any medical or neurological condition other than AD that is identified as contributing cause of the patient's dementia;
  • have a current diagnosis of probable or possible vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences criteria (NINDS-AIREN);
  • have a score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);
  • have a current DSM-IV diagnosis of major depression, unless, in the opinion of the investigator, is in remission for at least 12 weeks;

Other protocol-defined inclusion/exclusion criteria may apply

Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01399125
CENA713D2344
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2013

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