Citalopram for Agitation in Alzheimer's Disease (CitAD)
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|
++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.
University of Southern California Keck School of Medicine Memory and Aging Center
VA Palo Alto Health Care System
Johns Hopkins University
||New York||New York||10032||
Monroe Community Hospital
University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House
Medical University of South Carolina Alzheimer's Research and Clinical Programs
Centre for Addiction and Mental Health
Johns Hopkins University
- National Institute on Aging (NIA)
- National Institute of Mental Health (NIMH)
|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|
A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
- Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38.
- Steinberg M, Shao H, Zandi P, Lyketsos CG, Welsh-Bohmer KA, Norton MC, Breitner JC, Steffens DC, Tschanz JT; Cache County Investigators. Point and 5-year period prevalence of neuropsychiatric symptoms in dementia: the Cache County Study. Int J Geriatr Psychiatry. 2008 Feb;23(2):170-7.
- Pollock BG, Mulsant BH, Rosen J, Sweet RA, Mazumdar S, Bharucha A, Marin R, Jacob NJ, Huber KA, Kastango KB, Chew ML. Comparison of citalopram, perphenazine, and placebo for the acute treatment of psychosis and behavioral disturbances in hospitalized, demented pa