Seroquel- Agitation Associated With Dementia - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00621647

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease Vascular Dementia	Drug: Quetiapine Fumarate Drug: Placebo	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the efficacy of 2 fixed doses of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the efficacy of quetiapine compared with placebo [ Time Frame: Twice weekly ] [ Designated as safety issue: No ]

Enrollment:	333
Study Start Date:	September 2002
Study Completion Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 1st fixed dose	Drug: Quetiapine Fumarate Other Name: Seroquel
Experimental: 2 2nd fixed dose	Drug: Quetiapine Fumarate
Sham Comparator: 3 Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Hans Eriksson / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00621647 History of Changes
Other Study ID Numbers:	5077US/0046, D1446L00002
Study First Received:	February 6, 2008
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Seroquel
dementia
agitation symptoms

Alzheimer's disease
vascular dementia
quetiapine fumarate

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Dementia, Vascular
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012