CATIE-Alzheimer's Disease Trial

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00015548
• Other study ID #: N01 MH090001-05
• Secondary ID: N01 MH90001-ADDS
• Status: Completed
• Phase: N/A
• First received: April 20, 2001
• Last updated: June 16, 2015
• Start date: March 2001
• Est. completion date: October 2004

Study information

• Verified date: February 2009
• Source: National Institute of Mental Health (NIMH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Olanzapine

• Quetiapine

• Risperidone

• Citalopram

Locations

Country	Name	City	State
United States	Emory University - Wesley Woods Health Center	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Southwestern Vermont Medical Center- The Memory Clinic	Bennington	Vermont
United States	Mental Health Advocates, Inc.	Boca Raton	Florida
United States	Northwestern University Medical School	Chicago	Illinois
United States	VA Medical Center	Coatesville	Pennsylvania
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Berma Research Group	Hialeah	Florida
United States	University of Hawaii	Honolulu	Hawaii
United States	University of Iowa College of Medicine	Iowa City	Iowa
United States	University of California, Irvine Medical Center	Irvine	California
United States	University of California, Los Angeles, VA Medical Center	Los Angeles	California
United States	University of Southern California Dept of Psychiatry& Behavioral Sciences	Los Angeles	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Medical University of South Carolina	North Charleston	South Carolina
United States	Global Research and Consulting	Olean	New York
United States	Mental Illness Research Education and Clinical Center	Philadelphia	Pennsylvania
United States	University of Medicine and Dentistry of New Jersey	Piscataway	New Jersey
United States	Monroe Community Hospital	Rochester	New York
United States	University of California-San Diego, VA Medical Center	San Diego	California
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	Southern Illinois School of Medicine	Springfield	Illinois
United States	Millennium Psychiatric Associates	St. Louis	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	Staten Island University Hospital	Staten Island	New York
United States	University of Medicine and Dentistry of New Jersey-Stratford	Stratford	New Jersey
United States	University of South Florida Suncoast Gerontology Center	Tampa	Florida
United States	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama
United States	Palm Beach Neurology/Premiere Research Institute	West Palm Beach	Florida
United States	University Hospital Health Systems-Laurelwood Hospital	Willoughby	Ohio
United States	Wake Forest University School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Schneider 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. — View Citation

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 dise — View Citation

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. — View Citation