Alzheimer’s Disease Agitation Study

STUDY BASICS

Have you been diagnosed with Alzheimer’s disease? Do you experience feelings of irritability, restlessness, frustration, or anger? You may be able to participate in a research study to help find out if an antidepressant medication called escitalopram (Lexapro®) can help people who have Alzheimer’s disease with agitation. A friend or family member must also participate. Compensation provided.

STUDY PURPOSE

Alzheimer's disease is the most common cause of dementia—a condition that leads to memory loss, confusion, and difficulty completing daily tasks. Another common symptom of Alzheimer’s disease is agitation, which can be extremely difficult for both patients and caregivers. People with Alzheimer’s disease who are agitated may experience feelings of irritability, restlessness, frustration, or anger. The purpose of this study is to help researchers find out if an antidepressant medication called escitalopram (also known by the brand name Lexapro®) can lessen feelings of agitation in people who have Alzheimer’s disease. Escitalopram is approved by the FDA to treat sadness and anxiety but has not been tested for the treatment of agitation.

COULD THIS STUDY BE RIGHT FOR YOU?

• Diagnosed with Alzheimer’s disease by a doctor
• Experience feelings of irritability, restlessness, frustration, or anger
• Have a study partner (friend or family member) who is willing and able to attend all study visits with you

WHAT PARTICIPANTS CAN EXPECT

All participants and caregivers will receive one-on-one counseling throughout the study. These sessions will last from 30-60 minutes at the initial visit and for varying amounts of time at later visits. Your caregiver will also be given materials about how to care for someone who has Alzheimer’s disease with agitation. Three weeks after joining the study, participants who are still agitated will be randomly assigned (like the flip of a coin) into one of two study groups. One group will take pills with the antidepressant medication escitalopram and the other group will take placebo pills that do not contain any active medication. (Participants who are not agitated at three weeks after joining the study may stay in the study but will not receive any study drug.) Participants will be asked to come into the clinic four more times and will be called seven times on the telephone. These visits may include blood draws, an electrocardiogram (or ECG, done to measure electrical signals from your heart), blood pressure and pulse readings, and paper and pencil tests.