Escitalopram Treatment of Patients With Agitated Dementia
This study has been completed.
Sponsor:
University of Rochester
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
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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) |
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
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 May 16, 2013