Having memory problems? Trouble thinking clearly? If this sounds like you, or someone you know, please consider the ENGAGE Study. Patient Information

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1 Having memory problems? Trouble thinking clearly? If this sounds like you, or someone you know, please consider the ENGAGE Study Patient Information

2 Why is the ENGAGE Study needed? There is an important medical and scientific need to research investigational therapies that could delay memory loss and progression of disability in Alzheimer s disease. Currently, there are no approved treatments that slow the course of Alzheimer s disease. What is a clinical research study? A clinical research study is a scientific investigation designed to answer important questions about an investigational medication, such as: Is it safe? Does it work? Which dose works best? What are the side effects? All medications must be tested in clinical research studies before they are approved and available to be prescribed by doctors. Without people willing to volunteer for medical research and clinical research studies, it would be almost impossible to evaluate potential new treatments for medical conditions such as Alzheimer s disease, and few medical advances would be made. Choosing to take part in a clinical research study is a big decision. It is important that you understand what the study is about, the potential risks, and what it will involve for you before you agree to take part. We hope the information in this brochure will help you to decide whether you would like to take part in the ENGAGE Study. Participation in clinical research studies, such as the ENGAGE Study, provides an opportunity to contribute towards assessing the efficacy and safety of potential new treatment options. What is the ENGAGE Study? The ENGAGE Study is a clinical research study evaluating the efficacy and safety of an investigational medication in people experiencing symptoms of early Alzheimer s disease, such as problems with memory or thinking clearly. The investigational medication is thought to target and reduce harmful amyloid plaques (abnormal deposits) that form in the brains of people with Alzheimer s disease. The ENGAGE Study will aim to determine whether the investigational medication can remove the plaques and have an effect on the slowing of the progression of the condition. The information collected during this clinical research study about the investigational medication could lead to a potential treatment option for early Alzheimer s disease in the future.

3 As a volunteer, your privacy will be protected and all your medical records and personal information will remain confidential. Approximately 1350 people with symptoms of early Alzheimer s disease will take part in this study around the world. The study is made up of two phases: a placebo-controlled phase, and an optional long-term extension phase. - In the placebo-controlled phase, study participants will have a two-in-three chance of receiving the investigational medication, and a one-in-three chance of receiving placebo (which looks the same as the investigational medication, but contains no actual medication). Whether you receive the investigational medication or placebo will be decided at random (similar to flipping a coin). - In the optional long-term extension phase, all eligible participants will receive the investigational medication. The total study duration for people taking part in both the placebo-controlled and the long-term extension phases is approximately 4 years (less than 2 years for the placebocontrolled phase and a little over 2 years for the long-term extension phase). What will taking part in the ENGAGE Study involve? If you decide to take part in the ENGAGE Study and meet the eligibility requirements, you will need to visit the study center once or twice a month. You will also receive follow-up telephone calls after the first few doses of study medication (investigational medication or placebo) in each phase of the study, to check for safety. At your first three study center visits, tests and assessments will be done by the study doctor to make sure you are eligible for the study. If you are eligible to take part in the placebocontrolled phase, you will receive study medication every 4 weeks for approximately 18 months (1.5 years). You will receive 20 doses of study medication in total. If you are eligible to continue and take part in the optional long-term extension phase, you will receive the investigational medication every 4 weeks for approximately 100 weeks (approximately 2 years). You will receive a total of 26 doses of investigational medication during this extension phase. The study medication will be given via an intravenous infusion (a slow injection into a vein).

4 During study center visits, several tests and assessments will be done to monitor your health, which may include: - questionnaires and interviews about how well you are thinking, how well you are able to perform your daily activities, and how you are feeling - MRI (magnetic resonance imaging) scans, to produce detailed images of your brain - blood tests - urine tests - electrocardiogram (ECG; a test of the electrical activity of your heart) - physical examinations - measurement of your vital signs (blood pressure, heart rate, breathing rate, and temperature). You will need a study partner to accompany you to certain study center visits. This should be someone who helps you, such as a family member or close friend. - Your study partner must be able to provide information about you, such as how well you are thinking and performing daily activities, and whether you experience any side effects while taking the study medication, to the study staff. Can I take part in the ENGAGE Study? You may be eligible to participate in the ENGAGE Study if you: are years of age are experiencing symptoms that might be related to early Alzheimer s disease, such as problems with memory or thinking clearly have someone who can be your study partner (accompany you to certain appointments and provide information about your health). What else do I need to consider? Taking part in this study is voluntary. You can decide to stop taking part at any time, and it will not affect your future treatment options. The study team will fully explain the potential risks and benefits of taking part in the ENGAGE Study. Taking part in this study may or may not directly benefit you. However, the information gathered from this study may help to advance our knowledge of the investigational medication, and may benefit people with Alzheimer s disease in the future. If eligible, all study medication, examinations, and medical care will be provided at no cost to you. You will not be paid for your participation in the ENGAGE Study, but reasonable compensation for time and travel may be provided. Taking part in a clinical research study involves risks. These risks will be explained in detail by the study team before you decide to participate.

5 What should I do now? If you would like more information about taking part in the ENGAGE Study, and to help us to research and advance a potential treatment option for early Alzheimer s disease, please contact the study team using the details below. Patient Educational Brochure [V01 USA] BA-US-0098(1)