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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)

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ClinicalTrials.gov Identifier: NCT00777608
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : February 24, 2011
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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

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
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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

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
Donepezil 5-10 mg Participants were randomized to donepezil for 84 days
Placebo Participants were randomized to placebo for 84 days
Total Total of all reporting groups

Baseline Measures
   Donepezil 5-10 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   53   106 
Age, Customized [1] 
[Units: Participants]
 53   53   106 
[1] Age >= 55 years
Gender 
[Units: Participants]
     
Female   23   22   45 
Male   30   31   61 


  Outcome Measures

1.  Primary:   Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4   [ Time Frame: Baseline and 4 weeks ]

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 ]

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. ]


  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
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  More Information

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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp and Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00777608     History of Changes
Other Study ID Numbers: 0000-086
2008_573
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: January 27, 2011
Results First Posted: February 24, 2011
Last Update Posted: August 25, 2015