Escitalopram Treatment of Patients With Agitated Dementia

Condition(s) targeted: Alzheimer's Disease; Psychomotor Agitation

Intervention: Escitalopram (Lexapro) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Adrian Leibovici MD, Principal Investigator, Affiliation: University of Rochester

Overall contact:
Carol Basener, BSN, Phone: 585-275-4809, Email: carol_basener@urmc.rochester.edu

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.

Official title: Escitalopram in the Treatment of Patients With Agitated Dementia

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Agitation factor on the Neurobehavioral Rating Scale (NBRS)

Secondary outcome:

Total NBRS scores

Cohen-Mansfield Agitation Inventory

Neuropsychiatric Inventory

Global Clinical Impression of Change

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.

Minimum age: 61 Years. Maximum age: N/A. Gender(s): Both.

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

Carol Basener, BSN, Phone: 585-275-4809, Email: carol_basener@urmc.rochester.edu

University of Rochester, Rochester, New York 14642, United States; Recruiting
Adrian Leibovici, MD, Principal Investigator

Fairport Baptist Home, Fairport, New York 14450, United States; Recruiting
Adrian Leibovici, MD, Principal Investigator

The Highlands at Brighton, Rochester, New York 14618, United States; Recruiting
Adrian Leibovici, MD, Principal Investigator

Starting date: February 2003
Ending date: February 2007
Last updated: June 4, 2007