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Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) 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:
NCT00478205
First received: May 22, 2007
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
Results First Received: November 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Aricept (donepezil SR 23 mg)
Drug: Aricept (donepezil IR 10 mg)

  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
Donepezil SR 23 mg Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
Donepezil IR 10 mg Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.

Participant Flow:   Overall Study
    Donepezil SR 23 mg     Donepezil IR 10 mg  
STARTED     981     486  
COMPLETED     685     399  
NOT COMPLETED     296     87  
Adverse Event                 182                 39  
Medication Non-compliance                 9                 4  
Protocol Violation                 15                 5  
Request of Investigator or Sponsor                 4                 5  
Withdrawal by Subject                 61                 22  
Lack of Efficacy                 1                 0  
Not specified                 24                 12  



  Baseline Characteristics
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Reporting Groups
  Description
Donepezil SR 23 mg Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
Donepezil IR 10 mg Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
Total Total of all reporting groups

Baseline Measures
    Donepezil SR 23 mg     Donepezil IR 10 mg     Total  
Number of Participants  
[units: participants]
 		  963     471     1434  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  73.9  ± 8.53     73.8  ± 8.56     73.8  ± 8.53  
Gender [2]
[units: participants]
 		     
Female     607     294     901  
Male     356     177     533  
Race/Ethnicity, Customized [3]
[units: Participants]
 		     
Black     22     9     31  
White     708     346     1054  
Hispanic     67     26     93  
Native American     0     0     0  
Asian/Pacific     161     87     248  
Other     5     3     8  
[1] Safety Population
[2] Safety Population: All patients randomized who took at least one dose of study medication and who had at least one postbaseline safety assessment.
[3] Race (Safety Population)



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 24 in SIB Total Score   [ Time Frame: Baseline and Week 24 ]
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2.  Primary:   Overall Change From Baseline in Modified CIBIC+ to Week 24   [ Time Frame: Baseline and Week 24 ]
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3.  Secondary:   Change From Baseline to Week 24 in ADCS-ADL Total Score   [ Time Frame: Baseline and Week 24 ]
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4.  Secondary:   Change From Baseline to Week 24 in MMSE Total Score   [ Time Frame: Baseline and Week 24 ]
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  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
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Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


No publications provided by Eisai Inc.

Publications automatically indexed to this study:


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00478205     History of Changes
Other Study ID Numbers: E2020-G000-326
Study First Received: May 22, 2007
Results First Received: November 12, 2012
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency