Clinical Effectiveness of 10 cm^2 Rivastigmine Patch in Patients With Alzheimer's Disease (ADEPT)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00561392

First received: November 19, 2007

Last updated: April 10, 2012

Last verified: April 2012

History of Changes

Results First Received: December 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Alzheimer's Disease
Intervention:	Drug: Rivastigmine 5 and 10 cm^2 patch

Participant Flow

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Recruitment Details

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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 5 and 10 cm^2 Patch	For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.

Participant Flow: Overall Study

	Rivastigmine 5 and 10 cm^2 Patch
STARTED	208
COMPLETED	155
NOT COMPLETED	53
Adverse Event	38
Lack of Efficacy	2
Protocol Violation	1
Withdrawal by Subject	8
Administrative problems	4

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 5 and 10 cm^2 Patch	For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.

Baseline Measures

	Rivastigmine 5 and 10 cm^2 Patch
Overall Participants Analyzed [Units: Participants]	208

Age [Units: Years] Mean (Standard Deviation)	74 (7.7)

Gender [Units: Participants]
Female	110
Male	98

Region of Enrollment [Units: Participants]
Germany	208

Outcome Measures

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1. Primary:

Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study [ Time Frame: Baseline to Week 24 ]

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2. Primary:

Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study [ Time Frame: Baseline to Week 24 ]

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3. Primary:

Percentage of Participants Who Were Compliant to the 10 cm^2 Patch [ Time Frame: Baseline to Week 24 ]

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4. Secondary:

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

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5. Secondary:

Mean Change From Baseline in the Trail-making Test Part A Score at Week 24 [ Time Frame: Baseline to Week 24 ]

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6. Secondary:

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24 [ Time Frame: Baseline to Week 24 ]

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7. Secondary:

Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician [ Time Frame: Baseline to Week 24 ]

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8. Secondary:

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver [ Time Frame: Baseline t0 Week 24 ]

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9. Secondary:

Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24 [ Time Frame: Baseline to Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Articus K, Baier M, Tracik F, Kühn F, Preuss UW, Kurz A. A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease. Int J Clin Pract. 2011 Jul;65(7):790-6. doi: 10.1111/j.1742-1241.2011.02713.x. Epub 2011 Jun 6.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00561392 History of Changes
Other Study ID Numbers:	CENA713DDE15
Study First Received:	November 19, 2007
Results First Received:	December 15, 2010
Last Updated:	April 10, 2012

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