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Citalopram for Agitation in Alzheimer's Disease (CitAD)

Completed

The purpose of this study is to evaluate the safety and efficacy of the drug citalopram for treating agitation in Alzheimer's dementia.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A N/A Both No
July 2009
September 2013
200

++Probable Alzheimer's disease (NINCDS-ADRDA criteria), with MMSE score of 5-28++Clinically significant agitation for which a medication is needed, individual has score ≥ 4 on the Neuropsychiatric Inventory (NPI) agitation domain, and more than two agitated behaviors per week++Availability of primary caregiver, who spends several hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study++Sufficient fluency, of the patient and caregiver, in written and spoken English or Spanish++Stable treatment for Alzheimer's disease with cholinesterase inhibitors and/or memantine

++Major depression++Brain disease that might otherwise explain the presence of dementia, such as extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis++Psychosis (delusions or hallucinations) requiring antipsychotic treatment++Need for psychiatric hospitalization or acutely suicidal++Current participation in a clinical trial or any study that may add a significant burden or affect study outcomes++Any condition that makes it medically inappropriate or risky for the patient to enroll in the trial++Prohibited medications: Citalopram; failure of past treatment with citalopram for agitation after adequate trial at a minimally accepted dose (greater than or equal to 20 mg/day); any medication that would prohibit the safe concurrent use of citalopram, such as MAO inhibitors; current treatment with antipsychotics, anticonvulsants, other antidepressants (other than trazodone, less than or equal to 50 mg/day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants

This study is designed to examine the efficacy and safety of citalopram as treatment for significant agitation in people with Alzheimer's dementia. It will also investigate pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. Citalopram is a selective serotonin reuptake inhibitor, a type of antidepressant.

The management of agitation is a major priority in treating people with Alzheimer's disease. 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 show promise as a treatment for agitation in Alzheimer's, based on evidence of a link between agitation and brain serotonin system abnormalities in people with the diseaseAD patients, and on preliminary clinical data from a single-site, randomized controlled trial in which citalopram was superior to perphenazine and placebo.

Name City State Zip Status Primary Contact
University of Southern California Keck School of Medicine Memory and Aging Center
Los Angeles California 90089

VA Palo Alto Health Care System
Palo Alto California 94304

Johns Hopkins University
Baltimore Maryland 21224

Columbia University
New York New York 10032

Monroe Community Hospital
Rochester New York 14559

University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House
Philadelphia Pennsylvania 19104

Medical University of South Carolina Alzheimer's Research and Clinical Programs
Charleston South Carolina 29406

Centre for Addiction and Mental Health
Toronto Ontario M6J1H4

Johns Hopkins University

  • National Institute on Aging (NIA)
  • National Institute of Mental Health (NIMH)

Name Role Affiliation
Constantine Lyketsos, MD Study Chair Johns Hopkins University
Lon Schneider, MD Study Director University of Southern California Keck School of Medicine Memory and Aging Center
Bruce Pollock, MD Study Director Centre for Addiction and Mental Health
Jacobo Mintzer, MD Study Director Medical University of South Carolina Alzheimer's Research and Clinical Programs
David Shade, Esq Study Director Johns Hopkins University

Name Phone Email
Anne Roche 410-550-9024

NCT00898807

A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease