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Bupropion for the treatment of apathy in Alzheimer's dementia
2007-005352-17Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2009
- Countries
- 1
- Sponsor
- University of Bonn
- Modality
- Small Molecules
- Drugs
- bupropion
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 3, randomised, double-blind trial in None and Alzheimer's disease (AD) comparing Bupropion with Placebo (2 arms). Primary endpoint: Change in Apathy Evaluation Scale (AES) score at 12 weeks. Started Aug 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Bupropion
Patients receive bupropion for 12 weeks in a double-blind fashion.
Placebo
Patients receive matching placebo for 12 weeks in a double-blind fashion.
03
Who it enrols
Adults with Alzheimer's dementia and clinically significant apathy; healthy volunteers are not included. Detailed inclusion and exclusion criteria are not fully specified in the available registry summary.
04
Endpoints
Primary
Change in Apathy Evaluation Scale (AES) score at 12 weeks
Secondary
Quality of life
Cognition
Activities of daily living
Neuropsychiatric syndromes
Caregiver distress
Healthcare resource utilization
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