Seroquel- Agitation Associated With Dementia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease; Vascular Dementia
Intervention: Quetiapine Fumarate (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
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.
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study
Primary outcome: To assess the efficacy of 2 fixed doses of quetiapine compared with placebo
Secondary outcome: To assess the efficacy of quetiapine compared with placebo
Minimum age: 55 Years.
Maximum age: N/A.
- 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
- Subject must have a score of at least 14 on the PANSS
- Current or past symptoms for schizophrenia, schizoaffective disorder, or bipolar
- 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
Locations and Contacts
Starting date: September 2002
Ending date: March 2004
Last updated: February 28, 2008