Treatment of Apathy in Alzheimer's Disease With Modafinil

Brown University22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Apathy Alzheimer's Disease

Interventions

ModafinilDRUG

100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks

PlaceboDRUG

100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks

Eligibility

Sex: ALLMin age: 65 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Butler Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

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.

Time frame: at baseline

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.

Time frame: after 8 weeks of treatment

Secondary Outcomes

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.

Time frame: at baseline

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.

Time frame: at baseline

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.