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

2.  Primary:   Apathy   [ Time Frame: after 8 weeks of treatment ]
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3.  Secondary:   Lawton Brody Activities of Daily Living Questionnaire   [ Time Frame: at baseline ]
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4.  Secondary:   The Direct Assessment of Functional Status Scale   [ Time Frame: at baseline ]
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5.  Secondary:   Zarit Burden Inventory   [ Time Frame: at baseline ]
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6.  Secondary:   Lawton Brody Activities of Daily Living Questionnaire   [ Time Frame: after 8 weeks of treatment ]
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7.  Secondary:   The Direct Assessment of Functional Status Scale   [ Time Frame: after 8 weeks of treatment ]
  Show Outcome Measure 7

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


  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