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Tolerability of Rivastigmine Before and After Switching From Oral Formulation to Transdermal Patch in Alzheimer's Dementia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01585272
First received: April 23, 2012
Last updated: September 22, 2016
Last verified: September 2016
Results First Received: June 24, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Dementia
Intervention: Drug: ENA713

  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
Patients receiving Exelon patch 5 cm^2 were more than those receiving Exelon capsule for 4 weeks as least, because some patients had interrupted Exelon capsule for few days in the middle of 4-week Exelon capsule treatment, but still switched to Exelon patch 5 cm2

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rivastigmine Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.

Participant Flow:   Overall Study
    Rivastigmine
STARTED   121 
Safety Set   102 [1] 
Exelon Patch 5 cm2   114 
Exelon Patch 10 cm2   96 
COMPLETED   82 
NOT COMPLETED   39 
Adverse Event                22 
Protocol Violation                7 
Withdrawal by Subject                10 
[1] Subjects received 3 mg bid Exelon caps for more than 4 weeks & used at least 1 dose of Exelon patch.



  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.
No text entered.

Reporting Groups
  Description
Rivastigmine Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.

Baseline Measures
   Rivastigmine 
Overall Participants Analyzed 
[Units: Participants]
 102 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.8  (7.93) 
Gender 
[Units: Participants]
 
Female   52 
Male   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Adverse Events, Serious Adverse Events, and Death   [ Time Frame: Baseline through week 28 ]

2.  Secondary:   Change From Baseline in Mini-Mental Status Examination (MMSE)   [ Time Frame: Baselin, week 16, 28 and 52 ]

3.  Secondary:   Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)   [ Time Frame: Baseline, week 16, 28 and 52 ]

4.  Secondary:   The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment   [ Time Frame: Baseline through week 52 ]

5.  Secondary:   Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2   [ Time Frame: Baseline through week 52 ]


  Serious Adverse Events


  Other Adverse Events


  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:
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 Pharmaceutical
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01585272     History of Changes
Other Study ID Numbers: CENA713DTW04
Study First Received: April 23, 2012
Results First Received: June 24, 2016
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health