Treatment of Apathy in Alzheimer's Disease With Modafinil

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-09-30

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).

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Detailed Description

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Conditions

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Apathy Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cholinesterase inhibitor only

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Cholinesterase Plus Modafinil

Group Type EXPERIMENTAL

Modafinil

Intervention Type DRUG

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

Interventions

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Modafinil

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Provigil

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes