Treatment of Apathy in Alzheimer's Disease With Modafinil

Phase 3

Completed

• Conditions: Apathy; Alzheimer's Disease
• Interventions: Drug: Modafinil; Drug: Placebo

• Registration Number: NCT01172145
• Lead Sponsor: Brown University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study Completion: 2007-09
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Results First Submitted: 2010-08-04
• Status Verified: 2010-09
• Results First Submitted QC: 2011-02-09
• Last Update Submitted: 2011-02-09
• Results First Posted: 2011-03-04
• Last Update Posted: 2011-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholinesterase Plus Modafinil	Modafinil	-
Cholinesterase inhibitor only	Placebo	-

Primary Outcome Measures

Name	Time	Method
Apathy	after 8 weeks of treatment	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

Name	Time	Method
Lawton Brody Activities of Daily Living Questionnaire	after 8 weeks of treatment	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	after 8 weeks of treatment	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	after 8 weeks of treatment	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.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States