Seroquel- Agitation Associated With Dementia

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease; Vascular Dementia

Treatments: Drug: Quetiapine Fumarate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621647

D1446L00002

5077US/0046

Details and patient eligibility

About

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.

Enrollment: 333 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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333 participants in 3 patient groups

1

Experimental group

Description:

1st fixed dose

Treatment:

Drug: Quetiapine Fumarate

Drug: Quetiapine Fumarate

2

Experimental group

Description:

2nd fixed dose

Treatment:

Drug: Quetiapine Fumarate

Drug: Quetiapine Fumarate

3

Sham Comparator group

Description:

Placebo

Treatment:

Drug: Placebo