Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2003

Intervention(s) in this Clinical Trial

• Drug: Quetiapine Fumarate
• Drug: Quetiapine Fumarate
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 1st fixed dose
• Experimental: 2
  • 2nd fixed dose
• Sham Comparator: 3
  • Placebo

Primary Measures

• To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
  • Time Frame: Twice weekly
    Safety Issue?: No

Secondary Measures

• To assess the efficacy of quetiapine compared with placebo
  • Time Frame: Twice weekly
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621647

Study ID Number: 5077US/0046

ClinicalTrials.gov Identifier: NCT00621647

Health Authority: United States: Food and Drug Administration