Seroquel- Agitation Associated With Dementia

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 6, 2008
Last updated: March 24, 2009
Last verified: March 2009

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 3

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:

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
Drug: Placebo


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Hans Eriksson / Medical Science Director, AstraZeneca 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:
agitation symptoms
Alzheimer's disease
vascular dementia
quetiapine fumarate

Additional relevant MeSH terms:
Alzheimer Disease
Dementia, Vascular
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Vascular Diseases
Quetiapine Fumarate
Antipsychotic Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents processed this record on May 26, 2016