Seroquel- Agitation Associated With Dementia

AstraZeneca333 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

333

Conditions

Alzheimer's Disease Vascular Dementia

Interventions

Quetiapine FumarateDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Twice weekly

Secondary Outcomes

To assess the efficacy of quetiapine compared with placebo

Time frame: Twice weekly

Data from ClinicalTrials.gov

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