Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

This study has been completed.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01614886
First received: June 6, 2012
Last updated: June 3, 2015
Last verified: June 2015
Results First Received: April 16, 2015  
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: Active Comparator
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
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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 1 Step 1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
Rivastigmine Patch 3 Step 3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.

Participant Flow:   Overall Study
    Rivastigmine Patch 1 Step     Rivastigmine Patch 3 Step  
STARTED     107     109  
Safety Population (SAF)     107     108  
Full Analysis Set (FAS)     104     105  
COMPLETED     87     83  
NOT COMPLETED     20     26  
Adverse Event                 15                 20  
Withdrawal by Subject                 4                 4  
Death                 1                 0  
Protocol deviation                 0                 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.
Randomized set (RAN) The RAN consisted of all randomized patients. Patients were analyzed according to the treatment group they were assigned to at randomization. A patient was diagnosed of dementia with Lewy Bodies, different from AD, after randomization and was excluded from all analysis (SAF and FAS).

Reporting Groups
  Description
Rivastigmine Patch 1 Step 1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
Rivastigmine Patch 3 Step 3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
Total Total of all reporting groups

Baseline Measures
    Rivastigmine Patch 1 Step     Rivastigmine Patch 3 Step     Total  
Number of Participants  
[units: participants]
  107     109     216  
Age  
[units: Years]
Mean (Standard Deviation)
  77.5  (6.54)     77.6  (5.89)     77.5  (6.21)  
Gender, Customized [1]
[units: Participants]
     
Female     69     76     145  
Male     38     32     70  
[1] Baseline characteristics is based on safety analysis set therfore female number is 76.



  Outcome Measures
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1.  Primary:   Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation   [ Time Frame: Up to 24 weeks ]

2.  Secondary:   Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)   [ Time Frame: Baseline, 8,16, and 24 weeks ]

3.  Secondary:   Change From Baseline in Mini-Mental State Examination (MMSE)   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:   Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With “Improvement”: a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly   [ Time Frame: 4, 8, 12,16, 20 and 24 weeks ]

5.  Secondary:   The Percentage of Treatment Retention.   [ Time Frame: Up to 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: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01614886     History of Changes
Other Study ID Numbers: CENA713D1303
Study First Received: June 6, 2012
Results First Received: April 16, 2015
Last Updated: June 3, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)