Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00015548 |
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 | Intervention |
---|---|
Alzheimer's Disease |
Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Citalopram |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial) |
Estimated Enrollment: | 450 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | October 2004 |
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:
The Open-Choice Phase is designed to keep patients monitored in the trial for the 36-week duration.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion (prospective participants must not:)
Principal Investigator: | Lon Schneider, MD | University of Southern California |
Principal Investigator: | Pierre Tariot, MD | University of Rochester |
Study ID Numbers: | N01 MH90001-05, N01 MH90001-AD, DSIR AT |
Study First Received: | April 20, 2001 |
Last Updated: | November 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00015548 |
Health Authority: | United States: Federal Government |
antipsychotic treatment Alzheimer's disease agitation dementia |
psychosis behavioral symptoms hallucinations delusions |
Alzheimer Disease Hallucinations Risperidone Olanzapine Central Nervous System Diseases Psychomotor Agitation Brain Diseases Neurodegenerative Diseases Citalopram Serotonin Cognition Disorders |
Behavioral Symptoms Quetiapine Dopamine Delusions Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Psychotic Disorders Dexetimide Dementia Delirium |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Tauopathies Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |