CATIE-Alzheimer's Disease Trial
Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
5 other identifiers
interventional
450
1 country
34
Brief Summary
The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2001
Longer than P75 for not_applicable
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 20, 2001
CompletedFirst Posted
Study publicly available on registry
April 23, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedJune 17, 2015
February 1, 2009
April 20, 2001
June 16, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Dementia of the Alzheimer's Type
- Ambulatory, Outpatients who have an informant living/visiting at least 8 hours/week over 3-4 days.
- Presence of delusions, hallucinations, agitation impacting functioning and requiring medication treatment
- Agitation or psychotic symptoms began after signs or symptoms of dementia
- Be benefiting from psychotropic medication, antidepressants or anticonvulsants
- Be diagnosed with schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features.
- Have severe or unstable medical illness requiring active treatment
- Have hypersensitivity or intolerance of any of the study medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404, United States
University of California, Irvine Medical Center
Irvine, California, 92697, United States
University of Southern California Dept of Psychiatry& Behavioral Sciences
Los Angeles, California, 90033, United States
University of California, Los Angeles, VA Medical Center
Los Angeles, California, 90073, United States
University of California-San Diego, VA Medical Center
San Diego, California, 92161, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Mental Health Advocates, Inc.
Boca Raton, Florida, 33432, United States
Berma Research Group
Hialeah, Florida, 33016, United States
University of South Florida Suncoast Gerontology Center
Tampa, Florida, 33617, United States
Palm Beach Neurology/Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Emory University - Wesley Woods Health Center
Atlanta, Georgia, 30329, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Southern Illinois School of Medicine
Springfield, Illinois, 62702, United States
University of Iowa College of Medicine
Iowa City, Iowa, 52242, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Millennium Psychiatric Associates
St Louis, Missouri, 63044, United States
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, 08855-1382, United States
University of Medicine and Dentistry of New Jersey-Stratford
Stratford, New Jersey, 08084, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Global Research and Consulting
Olean, New York, 14760, United States
Monroe Community Hospital
Rochester, New York, 14620, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
University Hospital Health Systems-Laurelwood Hospital
Willoughby, Ohio, 44904, United States
VA Medical Center
Coatesville, Pennsylvania, 19320, United States
Mental Illness Research Education and Clinical Center
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
North Charleston, South Carolina, 29406, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235-9070, United States
Southwestern Vermont Medical Center- The Memory Clinic
Bennington, Vermont, 05201, United States
Related Publications (11)
Schneider LS, Tariot PN, Lyketsos CG, Dagerman KS, Davis KL, Davis S, Hsiao JK, Jeste DV, Katz IR, Olin JT, Pollock BG, Rabins PV, Rosenheck RA, Small GW, Lebowitz B, Lieberman JA. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer disease trial methodology. Am J Geriatr Psychiatry. 2001 Fall;9(4):346-60.
PMID: 11739062BACKGROUNDSchneider LS, Ismail MS, Dagerman K, Davis S, Olin J, McManus D, Pfeiffer E, Ryan JM, Sultzer DL, Tariot PN. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's disease trial. Schizophr Bull. 2003;29(1):57-72. doi: 10.1093/oxfordjournals.schbul.a006991.
PMID: 12908661BACKGROUNDSchneider 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. doi: 10.1056/NEJMoa061240.
PMID: 17035647RESULTReeves S, Bertrand J, Uchida H, Yoshida K, Otani Y, Ozer M, Liu KY, Bramon E, Bies R, Pollock BG, Howard R. Towards safer risperidone prescribing in Alzheimer's disease. Br J Psychiatry. 2021 May;218(5):268-275. doi: 10.1192/bjp.2020.225.
PMID: 33176899DERIVEDNagata T, Shinagawa S, Yoshida K, Noda Y, Shigeta M, Mimura M, Nakajima S. Early Improvements of Individual Symptoms With Antipsychotics Predict Subsequent Treatment Response of Neuropsychiatric Symptoms in Alzheimer's Disease: A Re-Analysis of the CATIE-AD Study. J Clin Psychiatry. 2020 Feb 11;81(2):19m12961. doi: 10.4088/JCP.19m12961.
PMID: 32074412DERIVEDOzawa C, Roberts R, Yoshida K, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1204-e1210. doi: 10.4088/JCP.17m11461.
PMID: 29045769DERIVEDYoshida K, Roberts R, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Lack of Early Improvement with Antipsychotics is a Marker for Subsequent Nonresponse in Behavioral and Psychological Symptoms of Dementia: Analysis of CATIE-AD Data. Am J Geriatr Psychiatry. 2017 Jul;25(7):708-716. doi: 10.1016/j.jagp.2017.01.016. Epub 2017 Jan 30.
PMID: 28215900DERIVEDMiller EA, Schneider LS, Rosenheck RA. Predictors of nursing home admission among Alzheimer's disease patients with psychosis and/or agitation. Int Psychogeriatr. 2011 Feb;23(1):44-53. doi: 10.1017/S1041610210000244. Epub 2010 Mar 10.
PMID: 20214847DERIVEDZheng L, Mack WJ, Dagerman KS, Hsiao JK, Lebowitz BD, Lyketsos CG, Stroup TS, Sultzer DL, Tariot PN, Vigen C, Schneider LS. Metabolic changes associated with second-generation antipsychotic use in Alzheimer's disease patients: the CATIE-AD study. Am J Psychiatry. 2009 May;166(5):583-90. doi: 10.1176/appi.ajp.2008.08081218. Epub 2009 Apr 15.
PMID: 19369318DERIVEDSultzer DL, Davis SM, Tariot PN, Dagerman KS, Lebowitz BD, Lyketsos CG, Rosenheck RA, Hsiao JK, Lieberman JA, Schneider LS; CATIE-AD Study Group. Clinical symptom responses to atypical antipsychotic medications in Alzheimer's disease: phase 1 outcomes from the CATIE-AD effectiveness trial. Am J Psychiatry. 2008 Jul;165(7):844-54. doi: 10.1176/appi.ajp.2008.07111779. Epub 2008 Jun 2.
PMID: 18519523DERIVEDRosenheck RA, Leslie DL, Sindelar JL, Miller EA, Tariot PN, Dagerman KS, Davis SM, Lebowitz BD, Rabins P, Hsiao JK, Lieberman JA, Schneider LS; Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) investigators. Cost-benefit analysis of second-generation antipsychotics and placebo in a randomized trial of the treatment of psychosis and aggression in Alzheimer disease. Arch Gen Psychiatry. 2007 Nov;64(11):1259-68. doi: 10.1001/archpsyc.64.11.1259.
PMID: 17984395DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lon Schneider, MD
University of Southern California
- PRINCIPAL INVESTIGATOR
Pierre Tariot, MD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 20, 2001
First Posted
April 23, 2001
Study Start
March 1, 2001
Study Completion
October 1, 2004
Last Updated
June 17, 2015
Record last verified: 2009-02