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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.
Study NCT00622713   Information provided by Novartis
First Received: February 14, 2008   Last Updated: August 5, 2008   History of Changes

February 14, 2008
August 5, 2008
January 2008
 
Percentage of patients treated by rivastigmine 10 cm2 patch sizes for at least 8 weeks at week 24 (ITT population)
Same as current
Complete list of historical versions of study NCT00622713 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
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)
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)

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

 
Phase IV
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Alzheimer's Disease
Drug: Rivastigmine transdermal patch
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
300
December 2008
 

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.

Both
50 Years and older
 
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00622713
External Affairs, Novartis
CENA713DFRO8, N° EudraCT : 2007-003405-27
Novartis
 
Principal Investigator: Novartis Pharma S.A.S. Novartis
Novartis
August 2008

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