A Research Program Studying Treatment Effectiveness
and Outcomes in Schizophrenia and Alzheimer’s Disease

About The CATIE Alzheimer's Disease Study

Patient recruitment for the CATIE Alzheimer's Disease Study will end on December 31st, 2003.

Many people with Alzheimer's disease develop symptoms including delusions, agitation, aggressive behavior, or hallucinations. These symptoms add to the many difficulties of living with Alzheimer's disease. The CATIE Alzheimer's Disease Study aims to find out the most effective medication treatments for these symptoms, and to improve the quality of life of people with Alzheimer's disease, their families, and caregivers.

The Role of the Caregiver

A family member or caregiver who has regular contact with the patient must be available to participate. The caregiver will assist with the participant's adherence to treatment and provide information during the study.

Participants and their caregivers will receive basic counseling and educational materials on Alzheimer's disease and advice on managing difficult behavior. They are offered intervention such as psychological support, education and skill development.

Caring for Study Participants

A specially trained physician and treatment team will carefully monitor each particpant throughout the study. Participants will continue to see their current physicians for other medical care. The CATIE study team will coordinate and communicate with the participant's regular health care provider.

Participants may continue taking medications for Alzheimer's and other health conditions (with some exceptions) and will continue to see their current physicians for routine medical care. Participants are followed for 9 months with approximately 11 clinic visits during this time.

Study medications and related medical care are provided free. Transportation reimbursement is available.

Eligible Participants

Individuals with Alzheimer's disease may be eligible to participate if they experience one or more of the following:

• delusions, or irrational beliefs (such as believing that someone is out to get them, or that caregivers aren't who they say they are)
• agitation (being restless, or easily upset)
• aggressive behavior (being verbally or physically aggressive)
• hallucinations (seeing or hearing things that are not actually there)

Study Medications

The CATIE Alzheimer's Disease Study is comparing the effectiveness of four FDA-approved medications for these symptoms:

• olanzapine (Zyprexa®)
• quetiapine (Seroquel®)
• risperidone (Risperdal®)
• citalopram (Celexa®)

At the beginning of the study, some participants may receive placebo (inactive pills) before they receive one of the study medications, but they will not remain on placebo if they do not improve.

Participants who improve on a study medication may stay on it, and those who do not benefit will be offered another active treatment. In this way, participants may try each study medication to find which one is most helpful for them.