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A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00622713
First received: February 14, 2008
Last updated: June 27, 2011
Last verified: June 2011
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Intervention: Drug: Rivastigmine transdermal patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rivastigmine Transdermal Patch During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.

Participant Flow:   Overall Study
    Rivastigmine Transdermal Patch  
STARTED     228  
Exposed to Study Drug     226  
Intent to Treat (ITT) Population     218  
COMPLETED     169  
NOT COMPLETED     59  
Adverse Event                 35  
Administrative problems                 4  
Withdrawal by Subject                 11  
Lost to Follow-up                 5  
Death                 2  
Subject no longer required study drug                 1  
Did not meet eligibility criteria                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivastigmine Transdermal Patch During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.

Baseline Measures
    Rivastigmine Transdermal Patch  
Number of Participants  
[units: participants]
  218  
Age [1]
[units: years]
Mean ± Standard Deviation
  78.7  ± 6.59  
Gender  
[units: participants]
 
Female     131  
Male     87  
Region of Enrollment  
[units: participants]
 
France     218  
[1] Baseline Measures are provided for the ITT population.



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study   [ Time Frame: 24 weeks ]

2.  Secondary:   Clinical Global Impression of Change (CGI-C) by Physician   [ Time Frame: Baseline and week 24 ]

3.  Secondary:   Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score   [ Time Frame: Baseline to week 24 ]

4.  Secondary:   Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score   [ Time Frame: Baseline to week 24 ]

5.  Secondary:   Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score   [ Time Frame: Baseline to week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00622713     History of Changes
Other Study ID Numbers: CENA713DFR08, N° EudraCT : 2007-003405-27
Study First Received: February 14, 2008
Results First Received: December 10, 2010
Last Updated: June 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)