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

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ClinicalTrials.gov Identifier: NCT00561392
Recruitment Status : Completed
First Posted : November 21, 2007
Results First Posted : March 11, 2011
Last Update Posted : April 16, 2012
Sponsor:
Information provided by:
Novartis

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

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 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

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 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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants Who Were Compliant to the 10 cm^2 Patch   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline in the Trail-making Test Part A Score at Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24   [ Time Frame: Baseline to Week 24 ]
  Show Outcome Measure 9


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

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


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


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00561392     History of Changes
Other Study ID Numbers: CENA713DDE15
First Submitted: November 19, 2007
First Posted: November 21, 2007
Results First Submitted: December 15, 2010
Results First Posted: March 11, 2011
Last Update Posted: April 16, 2012