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Seroquel- Agitation Associated With Dementia

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease; Vascular Dementia

Intervention: Quetiapine Fumarate (Drug); Quetiapine Fumarate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca


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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: To assess the efficacy of 2 fixed doses of quetiapine compared with placebo

Secondary outcome: To assess the efficacy of quetiapine compared with placebo


Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: September 2002
Last updated: March 24, 2009

Page last updated: August 23, 2015

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