Treatment of Apathy in Alzheimer's Disease With Modafinil

This study has been completed.
Sponsor:
Collaborators:
Cephalon
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT01172145
First received: July 28, 2010
Last updated: February 9, 2011
Last verified: September 2010
  Purpose

This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).


Condition Intervention Phase
Apathy
Alzheimer's Disease
Drug: Modafinil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Apathy in Alzheimer's Disease With Modafinil

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Apathy [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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.

  • Apathy [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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.

  • The Direct Assessment of Functional Status Scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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.

  • Zarit Burden Inventory [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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.

  • Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • The Direct Assessment of Functional Status Scale [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Zarit Burden Inventory [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: July 2005
Study Completion Date: September 2007
Arms Assigned Interventions
Placebo Comparator: Cholinesterase inhibitor only Drug: Placebo
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Experimental: Cholinesterase Plus Modafinil Drug: Modafinil
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Other Name: Provigil

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of mild to moderate stage Probable Alzheimer's disease
  • on a stable dose of a cholinesterase inhibitor medication for at least 30 days
  • clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion Criteria:

  • diagnosis of Major Depression
  • focal brain lesion on neuroimaging
  • history of significant substance abuse
  • history of significant head trauma with loss if consciousness >10 minutes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172145

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Cephalon
Investigators
Principal Investigator: Laura L Frakey, Ph.D. Memorial Hospital of Rhode Island
  More Information

No publications provided by Brown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Brown University:
apathy
Alzheimer's disease
activities of daily living performance
caregiver burden

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Modafinil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014