CATIE-Alzheimer's Disease Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00015548
Recruitment Status : Completed
First Posted : April 23, 2001
Last Update Posted : June 17, 2015
Information provided by:
National Institute of Mental Health (NIMH)

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Citalopram Not Applicable

Detailed Description:

There are four phases.

Phase I: In the initial treatment phase (Phase 1), patients will be randomized to one of the three atypical antipsychotics or placebo in the ratio 100:100:100:150 respectively. After two weeks, the investigator can move the patient to the next phase because of lack of efficacy or tolerability. At week 12, the investigator can decide whether the current medication is sufficiently optimal or it would be more beneficial to try another randomized medication.

Phase 2: Phase 2 starts when the patient is randomized to a second medication, i.e., olanzapine, quetiapine, risperidone, or citalopram. Patients will be randomized from an antipsychotic treatment to another antipsychotic treatment or citalopram in the ratio 3:3:2, or from placebo to an antipsychotic treatment or citalopram in the ratio 1:1:1:3 respectively. Therefore, 50% of patients who took placebo in Phase 1 will be randomized to an antipsychotic in Phase 2, and 50% will be randomized to citalopram in Phase 2. After the initial two weeks in Phase 2, the investigator can move the patient to the next phase, due to lack of efficacy or tolerability. After the patient has been on the Phase 2 study drug for approximately 12 weeks, the investigator can decide whether the current medication is sufficiently optimal or whether it would be more beneficial to try another randomized medication.

Phase 3: Phase 3 is randomized open-label treatment of one of the medications not previously received, i.e., olanzapine, quetiapine, risperidone, or citalopram. Treatment failures to the second treatment can be switched to a third open-label treatment. During Phase 3 patients will be maintained on their treatments openly and managed clinically until week 36.

If the investigator determines that the patient's response is not sufficiently optimal to the randomized open-label medication, then after the first two weeks of Phase 3, the investigator can prescribe another medication (of the investigator's choice) to the patient. If this occurs then patients are classed as being in the Open-Choice Phase.

Open-Choice Phase: The Open-Choice Phase can be entered at anytime during the 36-week study and directly from any of the three phases. There are four reasons a patient can enter the open choice phase:

  • Withdrawal from Phase 1 or Phase 2 with the patient or surrogate decision-maker refusing to proceed to the next randomized phase;
  • Withdrawal from Phase 3;
  • Withdrawal from current study drug from any of the three previous phases due to antipsychotic medication no longer being required in the opinion of the investigator; or
  • Withdrawal due to concomitant treatment with an exclusionary medication.

The Open-Choice Phase is designed to keep patients monitored in the trial for the 36-week duration.

Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
Study Start Date : March 2001
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion (prospective participants must not:)

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00015548

  Hide Study Locations
United States, Alabama
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
United States, California
University of California, Irvine Medical Center
Irvine, California, United States, 92697
University of Southern California Dept of Psychiatry& Behavioral Sciences
Los Angeles, California, United States, 90033
University of California, Los Angeles, VA Medical Center
Los Angeles, California, United States, 90073
University of California-San Diego, VA Medical Center
San Diego, California, United States, 92161
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Mental Health Advocates, Inc.
Boca Raton, Florida, United States, 33432
Berma Research Group
Hialeah, Florida, United States, 33016
University of South Florida Suncoast Gerontology Center
Tampa, Florida, United States, 33617
Palm Beach Neurology/Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University - Wesley Woods Health Center
Atlanta, Georgia, United States, 30329
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States, 60611
Southern Illinois School of Medicine
Springfield, Illinois, United States, 62702
United States, Iowa
University of Iowa College of Medicine
Iowa City, Iowa, United States, 52242
United States, Louisiana
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Missouri
Millennium Psychiatric Associates
St. Louis, Missouri, United States, 63044
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, United States, 08855-1382
University of Medicine and Dentistry of New Jersey-Stratford
Stratford, New Jersey, United States, 08084
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
Global Research and Consulting
Olean, New York, United States, 14760
Monroe Community Hospital
Rochester, New York, United States, 14620
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
University Hospital Health Systems-Laurelwood Hospital
Willoughby, Ohio, United States, 44904
United States, Pennsylvania
VA Medical Center
Coatesville, Pennsylvania, United States, 19320
Mental Illness Research Education and Clinical Center
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
North Charleston, South Carolina, United States, 29406
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235-9070
United States, Vermont
Southwestern Vermont Medical Center- The Memory Clinic
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: Lon Schneider, MD University of Southern California
Principal Investigator: Pierre Tariot, MD University of Rochester

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00015548     History of Changes
Other Study ID Numbers: N01 MH090001-05
N01 MH90001-AD
First Posted: April 23, 2001    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: February 2009

Keywords provided by National Institute of Mental Health (NIMH):
antipsychotic treatment
Alzheimer's disease
behavioral symptoms

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors