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Seroquel- Agitation Associated With Dementia

Primary Purpose

Alzheimer's Disease, Vascular Dementia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Quetiapine Fumarate
Quetiapine Fumarate
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Seroquel, dementia, agitation symptoms, Alzheimer's disease, vascular dementia, quetiapine fumarate

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    1

    2

    3

    Arm Description

    1st fixed dose

    2nd fixed dose

    Placebo

    Outcomes

    Primary Outcome Measures

    To assess the efficacy of 2 fixed doses of quetiapine compared with placebo

    Secondary Outcome Measures

    To assess the efficacy of quetiapine compared with placebo

    Full Information

    First Posted
    February 6, 2008
    Last Updated
    March 24, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00621647
    Brief Title
    Seroquel- Agitation Associated With Dementia
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    November 2003 (Actual)
    Study Completion Date
    November 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease, Vascular Dementia
    Keywords
    Seroquel, dementia, agitation symptoms, Alzheimer's disease, vascular dementia, quetiapine fumarate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    333 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    1st fixed dose
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    2nd fixed dose
    Arm Title
    3
    Arm Type
    Sham Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Quetiapine Fumarate
    Other Intervention Name(s)
    Seroquel
    Intervention Type
    Drug
    Intervention Name(s)
    Quetiapine Fumarate
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
    Time Frame
    Twice weekly
    Secondary Outcome Measure Information:
    Title
    To assess the efficacy of quetiapine compared with placebo
    Time Frame
    Twice weekly

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Seroquel- Agitation Associated With Dementia

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