Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 85 of 239 for:    (armodafinil)

Treatment of Apathy in Alzheimer's Disease With Modafinil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01172145
Recruitment Status : Completed
First Posted : July 29, 2010
Results First Posted : March 4, 2011
Last Update Posted : March 4, 2011
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Cephalon
Information provided by:
Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Apathy
Alzheimer's Disease
Interventions Drug: Modafinil
Drug: Placebo
Enrollment 22
Recruitment Details Participants were recruited from a Memory Disorders Clinic and the community between 2005 and 2007
Pre-assignment Details  
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description participants who received placebo participants who received modafinil (200 mg per day)
Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil Total
Hide Arm/Group Description participants who received placebo participants who received modafinil (200 mg per day) Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
1
   9.1%
1
   4.5%
>=65 years
11
 100.0%
10
  90.9%
21
  95.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
79.36  (7.62) 75.27  (8.34) 77.32  (8.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
7
  63.6%
4
  36.4%
11
  50.0%
Male
4
  36.4%
7
  63.6%
11
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Apathy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: T-score
88.91  (11.95) 95.64  (10.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cholinesterase Inhibitor Only, Cholinesterase Plus Modafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.385
Confidence Interval (2-Sided) 95%
-16.86 to 3.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.86
Estimation Comments [Not Specified]
2.Primary Outcome
Title Apathy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: T-score
82.09  (13.52) 89.09  (9.61)
3.Secondary Outcome
Title Lawton Brody Activities of Daily Living Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: raw score
19.00  (5.25) 16.18  (4.81)
4.Secondary Outcome
Title The Direct Assessment of Functional Status Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: raw score
89.09  (7.84) 84.55  (16.11)
5.Secondary Outcome
Title Zarit Burden Inventory
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: raw score
28.36  (21.09) 31.18  (8.73)
6.Secondary Outcome
Title Lawton Brody Activities of Daily Living Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: raw score
19.00  (5.54) 15.64  (5.43)
7.Secondary Outcome
Title The Direct Assessment of Functional Status Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: raw score
88.36  (8.35) 85.27  (14.16)
8.Secondary Outcome
Title Zarit Burden Inventory
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description:
participants who received placebo
participants who received modafinil (200 mg per day)
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: raw score
30.00  (20.56) 30.00  (4.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Hide Arm/Group Description participants who received placebo participants who received modafinil (200 mg per day)
All-Cause Mortality
Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cholinesterase Inhibitor Only Cholinesterase Plus Modafinil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      1/11 (9.09%)    
Nervous system disorders     
Motor Tics * [1]  0/11 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
[1]
assessed by study neurologist
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Laura L. Frakey
Organization: Brown University
Phone: 401-729-3163
Responsible Party: Laura L. Frakey, Brown University
ClinicalTrials.gov Identifier: NCT01172145     History of Changes
Other Study ID Numbers: 1F32MH075583-01 ( U.S. NIH Grant/Contract )
1F32MH075583-01 ( U.S. NIH Grant/Contract )
First Submitted: July 28, 2010
First Posted: July 29, 2010
Results First Submitted: August 4, 2010
Results First Posted: March 4, 2011
Last Update Posted: March 4, 2011