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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00898807 |
Purpose
The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Agitation |
Drug: citalopram Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: citalopram
target dose 30mg daily for 9 weeks
|
| 2: Placebo Comparator |
Drug: placebo
daily for 9 weeks
|
This study is designed to examine the efficacy and safety of citalopram as treatment for clinically significant agitation in Alzheimer's dementia (AD) patients. It will also investigate pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. The management of agitation is a major priority in treating patients with AD. Non-pharmacologic options have limited effectiveness. Several pharmacologic options have been explored, but findings for anticonvulsants, antipsychotics, and cholinesterase inhibitors are disappointing or associated with questionable risk-benefit ratio. Better pharmacologic options are needed. Selective serotonin reuptake inhibitors (SSRIs) show promise as a treatment for agitation in AD, based on evidence of a link between agitation and brain serotonin system abnormalities in AD patients, and on preliminary clinical data from a single-site, randomized controlled trial (RCT) in which citalopram was superior to perphenazine and placebo.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kristine Boehmer | 410-550-9024 | khalter1@jhmi.edu |
| United States, California | |
| University of Southern California Keck School of Medicine Memory and Aging Center | |
| Los Angeles, California, United States, 90089 | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, New York | |
| Monroe Community Hospital | |
| Rochester, New York, United States, 14559 | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Medical University of South Carolina Alzheimer's Research and Clinical Programs | |
| Charleston, South Carolina, United States, 29406 | |
| Canada, Ontario | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada, M6J1H4 | |
| Principal Investigator: | Constantine Lyketsos, MD, MHS | Johns Hopkins University |
| Study Director: | Lon Schneider, MD | University of Southern California Keck School of Medicine Memory and Aging Center |
| Study Director: | Bruce Pollock, MD | Centre for Addiction and Mental Health |
| Study Director: | Jacobo Mintzer, MD | Medical University of South Carolina Alzheimer's Research and Clinical Programs |
| Study Director: | Curtis Meinert, PhD | Johns Hopkins University |
More Information
| Responsible Party: | Johns Hopkins University ( Constantine Lyketsos, MD, MHS ) |
| Study ID Numbers: | IA0155, R01AG031348 |
| Study First Received: | May 11, 2009 |
| Last Updated: | May 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00898807 History of Changes |
| Health Authority: | United States: Federal Government |
|
BPSD neuropsychiatric symptoms aggression mood lability |
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Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action 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 Dementia Dexetimide Antidepressive Agents, Second-Generation Neurobehavioral Manifestations Antidepressive Agents Nervous System Diseases Alzheimer Disease Central Nervous System Diseases Dyskinesias Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists |