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

History of Changes

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
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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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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 ]

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2. Secondary:

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

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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 ]

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

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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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)

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