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Status:

COMPLETED

Escitalopram Treatment of Patients With Agitated Dementia

Lead Sponsor:

University of Rochester

Collaborating Sponsors:

Forest Laboratories

Conditions:

Alzheimer's Disease

Psychomotor Agitation

Eligibility:

All Genders

61+ years

Phase:

PHASE4

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.

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 aggr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2006

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00260624

Start Date

February 1 2003

End Date

December 1 2006

Last Update

February 24 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Fairport Baptist Home

Fairport, New York, United States, 14450

2

The Highlands at Brighton

Rochester, New York, United States, 14618

3

University of Rochester

Rochester, New York, United States, 14642