Treatment of Apathy in Alzheimer's Disease With Modafinil

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brown University
• Collaborators: Cephalon; National Institute of Mental Health (NIMH)
• Treatments: Armodafinil; Modafinil

Criteria

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