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A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00777608
First received: October 21, 2008
Last updated: March 24, 2011
Last verified: March 2011
History of Changes
Results First Received: January 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Comparator: Placebo 5mg (run in)
Drug: Donepezil 5 - 10 mg
Drug: Comparator: Placebo 5-10 mg
Drug: Donepezil 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 5-10 mg Participants were randomized to donepezil for 84 days
Placebo Participants were randomized to placebo for 84 days

Participant Flow:   Overall Study
    Donepezil 5-10 mg     Placebo  
STARTED     53     53  
COMPLETED     49     47  
NOT COMPLETED     4     6  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 1                 3  
Protocol Violation                 1                 0  
Investigator Decision                 1                 2  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4   [ Time Frame: Baseline and 4 weeks ]
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2.  Secondary:   Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12   [ Time Frame: Baseline and 2 weeks, 8 weeks and 12 weeks ]
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3.  Secondary:   Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12   [ Time Frame: Baseline and 4 weeks, 8 weeks and 12 weeks. ]
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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: Vice President of Late Stage Development
Organization: Merck Sharp and Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00777608     History of Changes
Other Study ID Numbers: MK-0000-086, 2008_573
Study First Received: October 21, 2008
Results First Received: January 27, 2011
Last Updated: March 24, 2011
Health Authority: Hungary: National Institute of Pharmacy