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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) (EXTRA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00622713
First Posted: February 25, 2008
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
Results First Submitted: December 10, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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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.
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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.

Baseline Measures
   Rivastigmine Transdermal Patch 
Overall Participants Analyzed 
[Units: Participants]
 218 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 78.7  (6.59) 
[1] Baseline Measures are provided for the ITT population.
Gender 
[Units: Participants]
 
Female   131 
Male   87 
Region of Enrollment 
[Units: Participants]
 
France   218 


  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



Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00622713     History of Changes
Other Study ID Numbers: CENA713DFR08
N° EudraCT : 2007-003405-27
First Submitted: February 14, 2008
First Posted: February 25, 2008
Results First Submitted: December 10, 2010
Results First Posted: July 26, 2011
Last Update Posted: July 26, 2011