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Seroquel- Agitation Associated With Dementia

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ClinicalTrials.gov Identifier: NCT00621647
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief 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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Vascular Dementia Drug: Quetiapine Fumarate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : September 2002
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To assess the efficacy of 2 fixed doses of quetiapine compared with placebo [ Time Frame: Twice weekly ]

Secondary Outcome Measures :
  1. To assess the efficacy of quetiapine compared with placebo [ Time Frame: Twice weekly ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Hans Eriksson / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00621647     History of Changes
Other Study ID Numbers: 5077US/0046
D1446L00002
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Seroquel
dementia
agitation symptoms
Alzheimer's disease
vascular dementia
quetiapine fumarate

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Psychomotor Agitation
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs