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Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

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ClinicalTrials.gov Identifier: NCT00506415
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer Disease
Interventions: Drug: Rivastigmine 5 cm^2
Drug: Rivastigmine 10 cm^2
Drug: Rivastigmine 15 cm^2
Drug: Placebo to 15 cm^2 patch
Drug: Placebo to 10 cm^2 patch

  Participant Flow


  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
Total Patients Total number of patients enrolled in the initial open label period that may have been randomized in the double blind period or may have continued in the extended open label period.

Baseline Measures
   Total Patients 
Overall Participants Analyzed 
[Units: Participants]
 1584 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.93  (7.131) 
Gender 
[Units: Participants]
 
Female   992 
Male   592 


  Outcome Measures

1.  Primary:   Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period   [ Time Frame: Baseline and week 48 of double blind period ]

2.  Primary:   Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period   [ Time Frame: Baseline and week 48 of double blind period ]

3.  Secondary:   Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period   [ Time Frame: 390 days was the maximum ]

4.  Secondary:   Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period   [ Time Frame: Baseline and week 48 of double blind period ]

5.  Secondary:   Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period   [ Time Frame: Baseline and week 48 of double blind period ]

6.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period   [ Time Frame: Baseline and week 48 of double blind period ]

7.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events   [ Time Frame: 30 days after a maximum of 96 weeks treatment ]


  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
No text entered.


  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
phone: 862 778 8300


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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00506415     History of Changes
Other Study ID Numbers: CENA713D2340
First Submitted: July 20, 2007
First Posted: July 25, 2007
Results First Submitted: May 1, 2012
Results First Posted: September 19, 2012
Last Update Posted: September 19, 2012