Seroquel- Agitation Associated With Dementia

A Multicenter, Double-Blind, Randomized, Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Agitation Associated With Dementia.

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 symptoms in nursing home or assisted care residents.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Inclusion Criteria:

• 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 Criteria:

• 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