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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01276353
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : August 1, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):

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 Type Dementia
Intervention: Drug: E2020

  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
No text entered.

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

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
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 
Overall Participants Analyzed 
[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

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

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



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01276353     History of Changes
Other Study ID Numbers: E2020-J081-221
First Submitted: January 12, 2011
First Posted: January 13, 2011
Results First Submitted: February 24, 2014
Results First Posted: August 1, 2014
Last Update Posted: August 8, 2014