Escitalopram Treatment of Patients With Agitated Dementia

Alzheimer's Disease Clinical Trial

Official title:

Escitalopram in the Treatment of Patients With Agitated Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260624
• Other study ID #: LXP MD 43
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2005
• Last updated: February 23, 2012
• Start date: February 2003
• Est. completion date: December 2006

Study information

• Verified date: February 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 61 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Psychomotor Agitation

Intervention

Drug:
• Escitalopram (Lexapro)

Locations

Country	Name	City	State
United States	Fairport Baptist Home	Fairport	New York
United States	The Highlands at Brighton	Rochester	New York
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agitation factor on the Neurobehavioral Rating Scale (NBRS)
Secondary	Total NBRS scores
Secondary	Cohen-Mansfield Agitation Inventory
Secondary	Neuropsychiatric Inventory
Secondary	Global Clinical Impression of Change