Escitalopram Treatment of Patients With Agitated Dementia

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00260624
First received: November 29, 2005
Last updated: February 23, 2012
Last verified: February 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escitalopram in the Treatment of Patients With Agitated Dementia

Resource links provided by NLM:


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
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Fairport Baptist Home
Fairport, New York, United States, 14450
University of Rochester
Rochester, New York, United States, 14642
The Highlands at Brighton
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
Forest Laboratories
Investigators
Principal Investigator: Adrian Leibovici MD University of Rochester
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260624     History of Changes
Other Study ID Numbers: LXP MD 43
Study First Received: November 29, 2005
Last Updated: February 23, 2012
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
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 21, 2014