Status:
COMPLETED
Seroquel- Agitation Associated With Dementia
Lead Sponsor:
AstraZeneca
Conditions:
Alzheimer's Disease
Vascular Dementia
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine how safe and effective Seroquel (quetiapine fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the treatment of agitation ...
Eligibility Criteria
Inclusion
- Subjects must have a diagnosis of dementia compatible with probable or possible Alzheimer's disease (AD)
- Subjects exhibit inappropriate verbal, vocal, or motor activity that requires treatment with an antipsychotic medication in addition to or beyond behavioural modification therapy
- Subject must have a score of at least 14 on the PANSS
Exclusion
- Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar disorder
- Symptoms of agitation that are caused by another general medical condition or direct physiological effects of a substance
- Failure to respond on 2 occasions to an adequate regimen of atypical antipsychotic medications for the treatment of agitation and/or aggression
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT00621647
Start Date
September 1 2002
End Date
November 1 2003
Last Update
March 25 2009
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