Seroquel- Agitation Associated With Dementia

NCT00621647 | Completed Phase 3

• 2 other identifiers: 5077US/0046D1446L00002
• Study Type: interventional
• Target: 333
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease; Vascular Dementia

Keywords

Seroquel; dementia; agitation symptoms; Alzheimer's disease; vascular dementia; quetiapine fumarate

Outcome Measures

Primary Outcomes (1)

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

  Twice weekly

Secondary Outcomes (1)

• To assess the efficacy of quetiapine compared with placebo

  Twice weekly

Study Arms (3)

1

EXPERIMENTAL

1st fixed dose

Drug: Quetiapine Fumarate

2

EXPERIMENTAL

2nd fixed dose

Drug: Quetiapine Fumarate

3

SHAM COMPARATOR

Placebo

Drug: Placebo

Interventions

Quetiapine Fumarate DRUG

Also known as: Seroquel

1

Placebo DRUG

3

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular; Dementia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 22, 2008
• Study Start: September 1, 2002
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: March 25, 2009

Record last verified: 2009-03