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Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 (ACTION)

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ClinicalTrials.gov Identifier: NCT00948766
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : February 11, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Rivastigmine 4.6 mg/24 h (5 cm^2)
Drug: Rivastigmine 9.5 mg/24 h (10 cm^2)
Drug: Rivastigmine 13.3 mg/24 h (15 cm^2)
Drug: Placebo

  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
One patient in each treatment group in the core study and one patient in the treatment group in the extension study did not receive study medication; they were not included in the safety set.

Reporting Groups
  Description
Rivastigmine 13.3 mg/24 h Transdermal Patch Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
Rivastigmine 4.6 mg/24 h Transdermal Patch Patients received rivastigmine 4.6 mg/24 h (5 cm^2).

Participant Flow for 2 periods

Period 1:   Core Study
    Rivastigmine 13.3 mg/24 h Transdermal Patch   Rivastigmine 4.6 mg/24 h Transdermal Patch
STARTED   356   360 
Exposed to Study Medication   355   359 
COMPLETED   229   234 
NOT COMPLETED   127   126 
Adverse Event                73                51 
Unsatisfactory Therapeutic Effect                13                14 
Patient Withdrew Consent                27                46 
Lost to Follow-up                3                2 
Administrative Problems                2                2 
Death                1                1 
Protocol Deviation                8                10 

Period 2:   Extension Study
    Rivastigmine 13.3 mg/24 h Transdermal Patch   Rivastigmine 4.6 mg/24 h Transdermal Patch
STARTED   397 [1]   0 [2] 
Exposed to Study Medication   396   0 
COMPLETED   306   0 
NOT COMPLETED   91   0 
Adverse Event                43                0 
Unsatisfactory Therapeutic Effect                2                0 
Study Drug No Longer Required                1                0 
Patient Withdrew Consent                32                0 
Lost to Follow-up                8                0 
Administrative Problems                1                0 
Death                4                0 
[1] 397 of the 463 patients who completed the core study entered the extension study.
[2] No patients received this treatment in the extension study.



  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
Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
Total Total of all reporting groups

Baseline Measures
   Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch   Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch   Total 
Overall Participants Analyzed 
[Units: Participants]
 356   360   716 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.6  (8.69)   76.5  (9.35)   77.0  (9.04) 
Gender 
[Units: Participants]
     
Female   227   234   461 
Male   129   126   255 


  Outcome Measures

1.  Primary:   Core Study: Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the core study ]

2.  Primary:   Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the core study ]

3.  Secondary:   Core Study: Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the core study ]

4.  Secondary:   Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the core study ]

5.  Secondary:   Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the extension study ]

6.  Secondary:   Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the extension study ]

7.  Secondary:   Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24   [ Time Frame: Baseline of the core study to Week 24 of the extension study ]


  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 Pharmaceuticals
phone: 862 778-8300


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00948766     History of Changes
Obsolete Identifiers: NCT01054755
Other Study ID Numbers: CENA713DUS44
First Submitted: July 28, 2009
First Posted: July 29, 2009
Results First Submitted: January 8, 2013
Results First Posted: February 11, 2013
Last Update Posted: August 28, 2013