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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
Enrollment 106

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil 5-10 mg Placebo
Hide Arm/Group Description Participants were randomized to donepezil for 84 days Participants were randomized to placebo for 84 days
Period Title: Overall Study
Started 53 53
Completed 49 47
Not Completed 4 6
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             3
Protocol Violation             1             0
Investigator Decision             1             2
Arm/Group Title Donepezil 5-10 mg Placebo Total
Hide Arm/Group Description Participants were randomized to donepezil for 84 days Participants were randomized to placebo for 84 days Total of all reporting groups
Overall Number of Baseline Participants 53 53 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
53 53 106
[1]
Measure Description: Age >= 55 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
Female
23
  43.4%
22
  41.5%
45
  42.5%
Male
30
  56.6%
31
  58.5%
61
  57.5%
1.Primary Outcome
Title Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4
Hide Description CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.
Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).
Arm/Group Title Donepezil 5-10 mg Placebo
Hide Arm/Group Description:
Participants were randomized to donepezil for 84 days
Participants were randomized to placebo for 84 days
Overall Number of Participants Analyzed 38 43
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.10  (0.07) -0.07  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 90%
-0.2 to 0.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12
Hide Description CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.
Time Frame Baseline and 2 weeks, 8 weeks and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).
Arm/Group Title Donepezil 5-10 mg Placebo
Hide Arm/Group Description:
Participants were randomized to donepezil for 84 days
Participants were randomized to placebo for 84 days
Overall Number of Participants Analyzed 38 43
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Week 2 (N=38, N=43) -0.2  (0.07) -0.006  (0.06)
Week 8 (N=38, N=40) -0.1  (0.07) -0.02  (0.07)
Week 12 (N=38, N=41) -0.2  (0.07) -0.09  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-0.3 to -0.008
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Statistical analysis for Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 90%
-0.3 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments Statistical analysis for Week 8
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.226
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 90%
-0.2 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments Statistical analysis for Week 12
3.Secondary Outcome
Title 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
Hide Description

The ADAS-Cog is a psychometric instrument that evaluates memory, attention,

reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline.

Time Frame Baseline and 4 weeks, 8 weeks and 12 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).
Arm/Group Title Donepezil 5-10 mg Placebo
Hide Arm/Group Description:
Participants were randomized to donepezil for 84 days
Participants were randomized to placebo for 84 days
Overall Number of Participants Analyzed 38 43
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Week 4 (N=38, N=43) 0.2  (0.8) -0.3  (0.7)
Week 8 (N=37, N=40) 0.07  (1.0) -0.7  (1.0)
Week 12 (N=38, N=40) -1.4  (1.0) -1.0  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Confidence Interval (2-Sided) 90%
-1.2 to 2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.0
Estimation Comments Statistical analysis for Week 4
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Confidence Interval (2-Sided) 90%
-1.5 to 3.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Donepezil 5-10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 90%
-2.6 to 1.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.3
Estimation Comments Statistical analysis for Week 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donezepil 5-10 mg Placebo
Hide Arm/Group Description Participants were randomized to donepezil for 84 days Participants were randomized to placebo for 84 days
All-Cause Mortality
Donezepil 5-10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Donezepil 5-10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/53 (5.66%)   0/53 (0.00%) 
Gastrointestinal disorders     
Inguinal hernia  1/53 (1.89%)  0/53 (0.00%) 
Injury, poisoning and procedural complications     
Head Injury  1/53 (1.89%)  0/53 (0.00%) 
Subdural haematoma  1/53 (1.89%)  0/53 (0.00%) 
Nervous system disorders     
Convulsion  1/53 (1.89%)  0/53 (0.00%) 
Renal and urinary disorders     
Urinary incontinence  1/53 (1.89%)  0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Donezepil 5-10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/53 (18.87%)   9/53 (16.98%) 
Gastrointestinal disorders     
Nausea * 1  7/53 (13.21%)  5/53 (9.43%) 
Nervous system disorders     
Dizziness * 1  3/53 (5.66%)  4/53 (7.55%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
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
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