Treatment of Apathy in Alzheimer's Disease With Modafinil

Study Overview
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Brief Summary
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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).

Official Title
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Treatment of Apathy in Alzheimer's Disease With Modafinil

Conditions
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Apathy, Alzheimer's Disease

Intervention / Treatment
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* Drug: Modafinil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cholinesterase inhibitor only<br> | Drug: Placebo<br>* 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks<br>|
| Experimental: Cholinesterase Plus Modafinil<br> | Drug: Modafinil<br>* 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks<br>* Other names: Provigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | at baseline | 
| 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. | after 8 weeks of treatment | 
| 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. | after 8 weeks of treatment | 
| 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. | after 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apathy, Alzheimer's disease, activities of daily living performance, caregiver burden