Status:
COMPLETED
Treatment of Apathy in Alzheimer's Disease With Modafinil
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Cephalon
Conditions:
Apathy
Alzheimer's Disease
Eligibility:
All Genders
65-95 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01172145
Start Date
July 1 2005
End Date
September 1 2007
Last Update
March 4 2011
Active Locations (1)
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1
Butler Hospital
Providence, Rhode Island, United States, 02906