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Oxcarbazepine for Agitation/Aggression in Dementia (OBAD)
NCT00145691Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2005
- Countries
- 1
- Sponsor
- Sykehuset Innlandet
- Modality
- Small Molecules
- Drugs
- oxcarbazepine
- Conditions
- Alzheimer's disease (AD)vascular dementia
01
Overview
Phase 3, randomised, double-blind trial in Alzheimer's disease (AD) and vascular dementia comparing Oxcarbazepine with Placebo (2 arms). Primary endpoint: Reduction in aggression and agitation as measured by NPI-NH-subscale agitation / aggression at 8 weeks. Started Sep 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Oxcarbazepine
Oxcarbazepine treatment arm.
Placebo
Placebo control arm.
03
Who it enrols
Patients aged 55 or older living in a nursing home with Alzheimer's or vascular dementia and significant agitation/aggression (NPI-NH subscale score >= 6).
04
Endpoints
Primary
Reduction in aggression and agitation as measured by NPI-NH-subscale agitation / aggression
Secondary
Reduction in aggression as measured by BARS
Reduction in the burden to health-care personnel as measured by NPI-NH
Concomitant use of acute medication (haloperidol)
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