CATIE-Alzheimer's Disease Trial

June 16, 2015 updated by: National Institute of Mental Health (NIMH)

Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Lon Schneider, MD, University of Southern California
  • Principal Investigator: Pierre Tariot, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

April 20, 2001

First Submitted That Met QC Criteria

April 21, 2001

First Posted (ESTIMATE)

April 23, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2015

Last Update Submitted That Met QC Criteria

June 16, 2015

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH090001-05
  • DSIR AT (NCT00590863)
  • N01 MH90001-AD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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