Escitalopram Treatment of Patients With Agitated Dementia - Full Text View

Sponsor:	University of Rochester
Collaborator:	Forest Laboratories
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00260624

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease Psychomotor Agitation	Drug: Escitalopram (Lexapro)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Escitalopram in the Treatment of Patients With Agitated Dementia

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Secondary Outcome Measures:

Total NBRS scores
Cohen-Mansfield Agitation Inventory
Neuropsychiatric Inventory
Global Clinical Impression of Change

Estimated Enrollment:	20
Study Start Date:	February 2003
Estimated Study Completion Date:	February 2007

Detailed Description:

This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.

Eligibility

Ages Eligible for Study:	61 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260624

Contacts

Contact: Carol Basener, BSN

585-275-4809

carol_basener@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Adrian Leibovici, MD
Fairport Baptist Home	Recruiting
Fairport, New York, United States, 14450
Principal Investigator: Adrian Leibovici, MD
The Highlands at Brighton	Recruiting
Rochester, New York, United States, 14618
Principal Investigator: Adrian Leibovici, MD

Sponsors and Collaborators

University of Rochester

Forest Laboratories

Investigators

Principal Investigator:

Adrian Leibovici MD

University of Rochester

More Information

No publications provided

Study ID Numbers:	LXP MD 43
Study First Received:	November 29, 2005
Last Updated:	June 4, 2007
ClinicalTrials.gov Identifier:	NCT00260624 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

agitation
dementia
Alzheimer's Disease

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Psychomotor Agitation
Cholinergic Agents
Neurodegenerative Diseases

Brain Diseases
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Psychomotor Disorders
Antidepressive Agents, Second-Generation
Dexetimide
Neurobehavioral Manifestations
Antidepressive Agents
Nervous System Diseases
Central Nervous System Diseases
Serotonin Uptake Inhibitors
Dyskinesias
Citalopram
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009