CATIE-Alzheimer's Disease Trial

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: Antipsychotic Agents; Citalopram; Olanzapine; Quetiapine Fumarate; Risperidone

Criteria

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