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Treatment of Apathy in Alzheimer's Disease With Modafinil

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Cephalon
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT01172145
First received: July 28, 2010
Last updated: February 9, 2011
Last verified: September 2010
History of Changes
Results First Received: August 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Apathy
Alzheimer's Disease
Interventions: Drug: Modafinil
Drug: Placebo

  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
Participants were recruited from a Memory Disorders Clinic and the community between 2005 and 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Participant Flow:   Overall Study
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)
Total Total of all reporting groups

Baseline Measures
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil     Total  
Number of Participants  
[units: participants]
 		  11     11     22  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     0     1     1  
>=65 years     11     10     21  
Age  
[units: years]
Mean ± Standard Deviation 		  79.36  ± 7.62     75.27  ± 8.34     77.32  ± 8.07  
Gender  
[units: participants]
 		     
Female     7     4     11  
Male     4     7     11  
Region of Enrollment  
[units: participants]
 		     
United States     11     11     22  



  Outcome Measures
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1.  Primary:   Apathy   [ Time Frame: at baseline ]

Measure Type Primary
Measure Title Apathy
Measure Description The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
Time Frame at baseline  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
Apathy  
[units: T-score]
Mean ± Standard Deviation 		  88.91  ± 11.95     95.64  ± 10.79  


Statistical Analysis 1 for Apathy
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.181
Mean Difference (Final Values) [4] -1.385
Standard Error of the mean ± 4.86
95% Confidence Interval ( -16.86 to 3.40 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   Apathy   [ Time Frame: after 8 weeks of treatment ]

Measure Type Primary
Measure Title Apathy
Measure Description The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
Time Frame after 8 weeks of treatment  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
Apathy  
[units: T-score]
Mean ± Standard Deviation 		  82.09  ± 13.52     89.09  ± 9.61  

No statistical analysis provided for Apathy



3.  Secondary:   Lawton Brody Activities of Daily Living Questionnaire   [ Time Frame: at baseline ]

Measure Type Secondary
Measure Title Lawton Brody Activities of Daily Living Questionnaire
Measure Description Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
Time Frame at baseline  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
Lawton Brody Activities of Daily Living Questionnaire  
[units: raw score]
Mean ± Standard Deviation 		  19.00  ± 5.25     16.18  ± 4.81  

No statistical analysis provided for Lawton Brody Activities of Daily Living Questionnaire



4.  Secondary:   The Direct Assessment of Functional Status Scale   [ Time Frame: at baseline ]

Measure Type Secondary
Measure Title The Direct Assessment of Functional Status Scale
Measure Description A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
Time Frame at baseline  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
The Direct Assessment of Functional Status Scale  
[units: raw score]
Mean ± Standard Deviation 		  89.09  ± 7.84     84.55  ± 16.11  

No statistical analysis provided for The Direct Assessment of Functional Status Scale



5.  Secondary:   Zarit Burden Inventory   [ Time Frame: at baseline ]

Measure Type Secondary
Measure Title Zarit Burden Inventory
Measure Description Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
Time Frame at baseline  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
Zarit Burden Inventory  
[units: raw score]
Mean ± Standard Deviation 		  28.36  ± 21.09     31.18  ± 8.73  

No statistical analysis provided for Zarit Burden Inventory



6.  Secondary:   Lawton Brody Activities of Daily Living Questionnaire   [ Time Frame: after 8 weeks of treatment ]

Measure Type Secondary
Measure Title Lawton Brody Activities of Daily Living Questionnaire
Measure Description Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
Time Frame after 8 weeks of treatment  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
Lawton Brody Activities of Daily Living Questionnaire  
[units: raw score]
Mean ± Standard Deviation 		  19.00  ± 5.54     15.64  ± 5.43  

No statistical analysis provided for Lawton Brody Activities of Daily Living Questionnaire



7.  Secondary:   The Direct Assessment of Functional Status Scale   [ Time Frame: after 8 weeks of treatment ]

Measure Type Secondary
Measure Title The Direct Assessment of Functional Status Scale
Measure Description A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
Time Frame after 8 weeks of treatment  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
The Direct Assessment of Functional Status Scale  
[units: raw score]
Mean ± Standard Deviation 		  88.36  ± 8.35     85.27  ± 14.16  

No statistical analysis provided for The Direct Assessment of Functional Status Scale



8.  Secondary:   Zarit Burden Inventory   [ Time Frame: after 8 weeks of treatment ]

Measure Type Secondary
Measure Title Zarit Burden Inventory
Measure Description Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
Time Frame after 8 weeks of treatment  
Safety Issue No  

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
Cholinesterase Inhibitor Only participants who received placebo
Cholinesterase Plus Modafinil participants who received modafinil (200 mg per day)

Measured Values
    Cholinesterase Inhibitor Only     Cholinesterase Plus Modafinil  
Number of Participants Analyzed  
[units: participants]
 		  11     11  
Zarit Burden Inventory  
[units: raw score]
Mean ± Standard Deviation 		  30.00  ± 20.56     30.00  ± 4.17  

No statistical analysis provided for Zarit Burden Inventory




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Laura L. Frakey
Organization: Brown University
phone: 401-729-3163
e-mail: lfrakey@gmail.com


No publications provided by Brown University

Publications automatically indexed to this study:


Responsible Party: Laura L. Frakey, Brown University
ClinicalTrials.gov Identifier: NCT01172145     History of Changes
Other Study ID Numbers: 1F32MH075583-01, 1F32MH075583-01
Study First Received: July 28, 2010
Results First Received: August 4, 2010
Last Updated: February 9, 2011
Health Authority: United States: Institutional Review Board