A Comparison of Two Standard Therapies in the Management of Dementia With Agitation

NCT00208819 | Completed Phase 4

• 1 other identifier: 0673-2003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether an antipsychotic medication alone or an antipsychotic medication in combination with divalproex is the most effective and safest way to treat agitation in elderly patients with dementia.

Conditions

Senile Dementia, Alzheimer Type; Dementia, Alzheimer Type; Alzheimer Disease; Dementia

Keywords

Alzheimer's Disease; Geriatric; Dementia; Agitation; Behavioral Disturbances; Psychosis

Outcome Measures

Primary Outcomes (8)

• Pittsburgh Agitation Scale (PAS)

• DiMarco Rating Scale for Extrapyramidal Symptoms

• UKU side effect rating scale:autonomic subscale

• Behavioral Activity Rating Scale (BARS)

• Visual Analog Scale for Nighttime Sleep and Daytime drowsiness (VAS)

• Confusion Assessment Method (CAM)

• Mini-Mental State Exam (MMSE)

• Cohen-Mansfield Agitation Inventory

Interventions

risperidone DRUG

quetiapine DRUG

olanzapine DRUG

divalproex DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• inpatients admitted to Wesley Woods Inpatient service for Dementia with psychosis and agitation; taking risperidone (up to 1.5 mg/day), quetiapine (up to 175 mg/day), or olanzapine (up to 7.5 mg/day)

You may not qualify if:

• prior sensitivity to risperidone, quetiapine, olanzapine or divalproex

Sponsors & Collaborators

• Emory University: lead
• Abbott: collaborator

Study Sites (1)

Wesley Woods Geriatric Hospital

Atlanta, Georgia, 30329, United States

Location

Related Publications (1)

• Tune L. Management of Noncognitive Symptoms of Dementia. Essentials of Clinical Psychopharmacology, 2nd ed. 2001: 935-948.

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Psychomotor Agitation; Mental Disorders; Psychotic Disorders

Interventions

Risperidone; Quetiapine Fumarate; Olanzapine; Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Larry E. Tune, MD, MAS

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2003
• Study Completion: July 1, 2007
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (1)