A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01276353
First received: January 12, 2011
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: February 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Type Dementia
Intervention: Drug: E2020

  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
E2020 SR 23 mg E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
E2020 10 mg E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.

Participant Flow for 2 periods

Period 1:   Double-blind
    E2020 SR 23 mg     E2020 10 mg  
STARTED     22     23  
COMPLETED     19     23  
NOT COMPLETED     3     0  
Adverse Event                 2                 0  
Withdrawal by Subject                 1                 0  

Period 2:   Extension
    E2020 SR 23 mg     E2020 10 mg  
STARTED     19     23  
COMPLETED     12     14  
NOT COMPLETED     7     9  
Adverse Event                 2                 5  
Withdrawal by Subject                 1                 2  
Withdrawal of study drug 4 days in a row                 3                 1  
Physician Decision                 1                 0  
Prohibited concomitant medications                 0                 1  



  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
E2020 SR 23 mg E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
E2020 10 mg E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
Total Total of all reporting groups

Baseline Measures
    E2020 SR 23 mg     E2020 10 mg     Total  
Number of Participants  
[units: participants]
  22     23     45  
Age  
[units: Years]
Mean ± Standard Deviation
  79.3  ± 9.8     73.6  ± 10.8     76.4  ± 10.6  
Gender  
[units: Participants]
     
Female     16     16     32  
Male     6     7     13  
Hachinski Score [1]
[units: Scores on a Scale]
Mean ± Standard Deviation
  1.1  ± 1.3     0.7  ± 1.1     0.9  ± 1.2  
[1] The Hachinski Ischaemic Score (HIS) is an attempt to differentiate Alzheimer's type dementia and multi-infarct dementia. It uses a system of 13 features of with a score of 1 or 2, adding the scores together for a final score. A cut-off score less than or equal to 4 for Dementia of Alzheimer’s Type (DAT) and greater than or equal to 7 for Vascular Dememntia (VaD) has a sensitivity of 89% and a specificity of 89%.



  Outcome Measures
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1.  Primary:   Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3   [ Time Frame: Visit 2 [Day1] and Visit 3 [Day 15] ]

2.  Secondary:   Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status   [ Time Frame: Visit 2 [Day1] and Visit 3 [Day 15] ]


  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: Naoki Kubota
Organization: Clinical Development. JAC PCU. Eisai Co., Ltd.
phone: +81-3-3817-5245


No publications provided


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01276353     History of Changes
Other Study ID Numbers: E2020-J081-221
Study First Received: January 12, 2011
Results First Received: February 24, 2014
Last Updated: August 5, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare