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Treatment of Apathy in Alzheimer's Disease With Modafinil

Primary Purpose

Apathy, Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apathy focused on measuring apathy, Alzheimer's disease, activities of daily living performance, caregiver burden

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Cholinesterase inhibitor only

Cholinesterase Plus Modafinil

Arm Description

Outcomes

Primary Outcome Measures

Apathy
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
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
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
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
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
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
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
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.

Full Information

First Posted
July 28, 2010
Last Updated
February 9, 2011
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH), Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT01172145
Brief Title
Treatment of Apathy in Alzheimer's Disease With Modafinil
Official Title
Treatment of Apathy in Alzheimer's Disease With Modafinil
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH), Cephalon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy, Alzheimer's Disease
Keywords
apathy, Alzheimer's disease, activities of daily living performance, caregiver burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholinesterase inhibitor only
Arm Type
Placebo Comparator
Arm Title
Cholinesterase Plus Modafinil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Primary Outcome Measure Information:
Title
Apathy
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
Title
Apathy
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
Secondary Outcome Measure Information:
Title
Lawton Brody Activities of Daily Living Questionnaire
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
Title
The Direct Assessment of Functional Status Scale
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
Title
Zarit Burden Inventory
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
Title
Lawton Brody Activities of Daily Living Questionnaire
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
Title
The Direct Assessment of Functional Status Scale
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
Title
Zarit Burden Inventory
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura L Frakey, Ph.D.
Organizational Affiliation
Memorial Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22687392
Citation
Frakey LL, Salloway S, Buelow M, Malloy P. A randomized, double-blind, placebo-controlled trial of modafinil for the treatment of apathy in individuals with mild-to-moderate Alzheimer's disease. J Clin Psychiatry. 2012 Jun;73(6):796-801. doi: 10.4088/JCP.10m06708. Epub 2012 May 15.
Results Reference
derived

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Treatment of Apathy in Alzheimer's Disease With Modafinil

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