Alzheimer's Disease, Vascular Dementia
Conditions
Keywords
Seroquel, dementia, agitation symptoms, Alzheimer's disease, vascular dementia, quetiapine fumarate
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.
Interventions
DRUGQuetiapine Fumarate
DRUGPlacebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of 2 fixed doses of quetiapine compared with placebo | Twice weekly |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of quetiapine compared with placebo | Twice weekly |
Outcome results
None listed