CompletedPhase 3

Seroquel- Agitation Associated With Dementia

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.

Lead sponsor

AstraZeneca

Asset

Quetiapine

Listed sites

Recruiting sites

Enrollment

333

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Efficacy of 2 fixed doses of quetiapine

Identifiers

Registered as

Org study ID5077US/0046

SecondaryD1446L00002

NCT IDNCT00621647

Timeline

Milestones

Study start2002-09 (month precision)

Primary completion2003-11actual (month precision)

Study completion2003-11actual (month precision)

Study first posted2008-02-22estimated

Last update posted2009-03-25estimated

Assets

Drug assets

Quetiapine

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Twice weekly

descriptive

Secondary/protocol endpoint/low confidence

To assess the efficacy of quetiapine compared with placebo

Time frame:Twice weekly

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.