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Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00566501
First received: November 29, 2007
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
Results First Received: May 16, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: 23 mg SR in Study 326
Drug: 10 mg IR in Study 326

  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
This study was recruited at 179 centers in Asia, Europe, North America, Oceania, South Africa, and South America during the period of 14 December 2007 to 01 April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enter here: This study (E2020-G000-328) was a 12-month, open-label extension of study E2020-G000-326. Subjects who had received donepezil 10 mg IR or donepezil 23 mg IR during Study 326 were eligible for enrollment into this study.

Reporting Groups
  Description
23 mg SR in Study 326 Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
10 mg IR in Study 326 Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.

Participant Flow:   Overall Study
    23 mg SR in Study 326     10 mg IR in Study 326  
STARTED     579     336  
Safety Population     570     332  
Discontinued     146     122  
Adverse Event     68     59  
Lack of Efficacy     8     3  
Withdraw of Consent by Subject     33     30  
Request of Investigator or Sponsor     6     7  
Protocol Violation     2     2  
Medication Non-compliance     5     0  
Other ( Not Specified)     24     21  
Not Determined     1     0  
COMPLETED     423     210  
NOT COMPLETED     156     126  



  Baseline Characteristics
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Reporting Groups
  Description
23 mg SR in Study 326 Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
10 mg IR in Study 326 Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
Total Total of all reporting groups

Baseline Measures
    23 mg SR in Study 326     10 mg IR in Study 326     Total  
Number of Participants  
[units: participants]
 		  579     336     915  
Age  
[units: years]
Mean ± Standard Deviation 		  74.1  ± 8.63     74.5  ± 8.46     74.2  ± 8.56  
Gender  
[units: participants]
 		     
Female     378     204     582  
Male     201     132     333  
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     82     62     144  
Black or African American     17     7     24  
White     435     246     681  
Other ( not specified)     3     2     5  
Hispanic     42     19     61  



  Outcome Measures

1.  Primary:   Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period   [ Time Frame: Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs) ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in MMSE Score   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Mean Change From Baseline in SIB Score   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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 NOT 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.


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.  


Results Point of Contact:  
Name/Title: Andrew Satlin, Senior Vice President, Neuroscience Product Creation Unit
Organization: Eisai, Inc.
phone: 201-949-4597
e-mail: Andrew_Satlin@eisai.com


No publications provided


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00566501     History of Changes
Other Study ID Numbers: E2020-G000-328
Study First Received: November 29, 2007
Results First Received: May 16, 2012
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency