CATIE-Alzheimer's Disease Trial
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| ClinicalTrials.gov Identifier: NCT00015548 |
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Recruitment Status
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Completed
First Posted
: April 23, 2001
Last Update Posted
: June 17, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Citalopram | Not Applicable |
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 |
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| 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
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 ClinicalTrials.gov identifier (NCT number): NCT00015548
Show 34 Study Locations
| 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 ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00015548 History of Changes |
| Other Study ID Numbers: |
N01 MH090001-05 N01 MH90001-AD DSIR AT |
| 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):
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antipsychotic treatment Alzheimer's disease agitation dementia |
psychosis behavioral symptoms hallucinations delusions |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Risperidone Antipsychotic Agents Olanzapine Quetiapine Fumarate Citalopram 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 Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |