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| Sponsor: | University of Rochester |
|---|---|
| Collaborator: |
Forest Laboratories |
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00260624 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Escitalopram in the Treatment of Patients With Agitated Dementia |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | February 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carol Basener, BSN | 585-275-4809 | carol_basener@urmc.rochester.edu |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: Adrian Leibovici, MD | |
| Fairport Baptist Home | Recruiting |
| Fairport, New York, United States, 14450 | |
| Principal Investigator: Adrian Leibovici, MD | |
| The Highlands at Brighton | Recruiting |
| Rochester, New York, United States, 14618 | |
| Principal Investigator: Adrian Leibovici, MD | |
| Principal Investigator: | Adrian Leibovici MD | University of Rochester |
More Information
| Study ID Numbers: | LXP MD 43 |
| Study First Received: | November 29, 2005 |
| Last Updated: | June 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00260624 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
agitation dementia Alzheimer's Disease |
|
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Psychomotor Agitation Cholinergic Agents Neurodegenerative Diseases Brain Diseases Signs and Symptoms Mental Disorders |
Therapeutic Uses Psychomotor Disorders Antidepressive Agents, Second-Generation Dementia Dexetimide Neurobehavioral Manifestations Antidepressive Agents Nervous System Diseases Alzheimer Disease Central Nervous System Diseases Serotonin Uptake Inhibitors Dyskinesias Citalopram Pharmacologic Actions Muscarinic Antagonists |