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A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01399125
First received: July 19, 2011
Last updated: July 10, 2014
Last verified: July 2014
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Rivastigmine Patch
Drug: Rivastigmine Capsules
Drug: Placebo to Rivastigmine patch
Drug: Placebo to Rivastigmine capsules

  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
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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 Patch Once-daily target patch size 10 cm²
Rivastigmine Capsules Twice-daily target dose of 6 mg oral capsule

Participant Flow:   Overall Study
    Rivastigmine Patch     Rivastigmine Capsules  
STARTED     248     253  
Per Protocol (PP) Population     192     188  
COMPLETED     197     193  
NOT COMPLETED     51     60  
Adverse Event                 32                 30  
Abnormal Lab values                 0                 1  
Unsatisfactory Therapeutic Effect                 0                 4  
Withdrawal by Subject                 5                 8  
Lost to Follow-up                 2                 3  
Administrative Problems                 7                 11  
Death                 0                 1  
Protocol Deviation                 5                 2  



  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 Patch Once-daily target patch size 10 cm²
Rivastigmine Capsules Twice-daily target dose of 6 mg oral capsule
Total Total of all reporting groups

Baseline Measures
    Rivastigmine Patch     Rivastigmine Capsules     Total  
Number of Participants  
[units: participants]
  248     253     501  
Age  
[units: years]
Mean ± Standard Deviation
  70.4  ± 8.02     69.8  ± 8.20     70.1  ± 8.11  
Gender  
[units: participants]
     
Female     140     139     279  
Male     108     114     222  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)   [ Time Frame: Change at 24 weeks ]

2.  Secondary:   Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)   [ Time Frame: Change at 24 weeks ]

3.  Secondary:   Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score   [ Time Frame: Change at 24 weeks ]

4.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score   [ Time Frame: Change at 24 weeks ]

5.  Secondary:   Change From Baseline in Mini-Mental State Examination (MMSE) Total Score   [ Time Frame: Change at 24 weeks ]


  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 Pharmaceuticals
phone: 8627788300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01399125     History of Changes
Other Study ID Numbers: CENA713D2344
Study First Received: July 19, 2011
Results First Received: May 5, 2014
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
China: Ethics Committee
China: Food and Drug Administration