ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)

This study is ongoing, but not recruiting participants.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00622713
  Purpose

This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting


Condition Intervention Phase
Alzheimer's Disease
Drug: Rivastigmine transdermal patch
Phase IV

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease   

ChemIDplus related topics:   Rivastigmine    SDZ-ENA 713   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-Daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (MMSE 10-26)

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of patients treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population)

Secondary Outcome Measures:
  • Mini-Mental State Examination score at baseline, week 8, 24 and premature discontinuation
  • Clinical Global Impression of Change (week 8, 24 and premature discontinuation)
  • 4 scores from the Activities of Daily Living (budget, transport, drug management, phone) at baseline, week 8 and week 24 or at premature discontinuation
  • At any time : Adverse events, vital signs, physical examination

Estimated Enrollment:   300
Study Start Date:   January 2008
Estimated Study Completion Date:   December 2008

Arms Assigned Interventions
1: Experimental Drug: Rivastigmine transdermal patch

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • Males, and females of at least 50 years old with a primary caregiver
  • Probable Alzheimer's disease
  • Mini-Mental State Examination score of ≥ 10 and ≤ 26
  • Patients initiating therapy for the first time with a ChE inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
  • Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday

Exclusion Criteria:

  • Patients not treated according to the product monograph for capsules
  • Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
  • History of allergy to topical products containing any of the constituents of the patches

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622713

Locations
France
Novartis Investigative Site    
      Rueil-Malmaison, France

Sponsors and Collaborators
Novartis

Investigators
Principal Investigator:     Novartis Pharma S.A.S.     Novartis    
  More Information

Responsible Party:   Novartis ( External Affairs )
Study ID Numbers:   CENA713DFRO8, N° EudraCT : 2007-003405-27
First Received:   February 14, 2008
Last Updated:   August 5, 2008
ClinicalTrials.gov Identifier:   NCT00622713
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:
Alzheimer's disease  
cholinesterase inhibitor  
rivastigmine  

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Rivastigmine
Arnold-Chiari Malformation
Mental Disorders
Arnold-Chiari malformation
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Therapeutic Uses
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers