Escitalopram Treatment of Patients With Agitated Dementia

NCT00260624 | Completed Phase 4

• 1 other identifier: LXP MD 43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.

Conditions

Alzheimer's Disease; Psychomotor Agitation

Keywords

agitation; dementia; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Secondary Outcomes (4)

• Total NBRS scores

• Cohen-Mansfield Agitation Inventory

• Neuropsychiatric Inventory

• Global Clinical Impression of Change

Interventions

Escitalopram (Lexapro) DRUG

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dementia of Alzheimer's type with behavioral disturbance
• Mild to severe cognitive impairment
• Age over 60
• Medically stable
• Agitation present both at screening and baseline
• Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
• Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
• No planned change in environment for duration of study
• At least one reliable caregiver

You may not qualify if:

• Any intercurrent medical problem that could explain the agitation
• History of major depression or bipolar preceding the onset of dementia
• Other major psychiatric illness preceding the onset of dementia or mental retardation
• Other dementias
• History of alcohol abuse or dependence in the last 2 years
• Delirium (or history of delirium in the last 8 weeks)
• Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
• Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
• Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
• History of intolerance to citalopram
• Noncompliance with oral medication or inability to take oral medication
• Modified Hachinski score of 4 or greater

Sponsors & Collaborators

• University of Rochester: lead
• Forest Laboratories: collaborator

Study Sites (3)

Fairport Baptist Home

Fairport, New York, 14450, United States

Location

The Highlands at Brighton

Rochester, New York, 14618, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation; Dementia

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adrian Leibovici MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: February 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (3)