Treatment of Apathy in Alzheimer's Disease With Modafinil

Brown University

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease; Apathy

Treatments: Drug: Modafinil; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01172145

1F32MH075583-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 65 to 95 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Cholinesterase inhibitor only

Placebo Comparator group

Treatment:

Drug: Placebo

Cholinesterase Plus Modafinil

Experimental group

Treatment:

Drug: Modafinil