Seroquel- Agitation Associated With Dementia

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621647
• Other study ID #: 5077US/0046
• Secondary ID: D1446L00002
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2008
• Last updated: March 24, 2009
• Start date: September 2002
• Est. completion date: November 2003

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Drug:
• Quetiapine Fumarate

• Quetiapine Fumarate

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of 2 fixed doses of quetiapine compared with placebo		Twice weekly	No
Secondary	To assess the efficacy of quetiapine compared with placebo		Twice weekly	No