Escitalopram Treatment of Patients With Agitated Dementia

University of Rochester

Status and phase

Completed

Phase 4

Conditions

Psychomotor Agitation

Alzheimer's Disease

Treatments

Drug: Escitalopram (Lexapro)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00260624

LXP MD 43

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

61+ years old

Volunteers

No Healthy Volunteers

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