People who are experiencing symptoms that may be related to early Alzheimer’s disease, such as problems with memory or thinking clearly.
About The Study:
Approximately 2700 people are needed to participate in the ENGAGE and EMERGE Studies. The two studies are identical but will be carried out in different locations around the world. People who qualify will participate in either the ENGAGE Study or the EMERGE Study, but not both.
To assess the efficacy and safety of an investigational medication to determine whether it can slow progression of symptoms in early Alzheimer’s disease.
What Is Involved:
The ENGAGE and EMERGE Studies are split into two phases: a placebo-controlled phase, and an optional long-term extension phase.
In the placebo-controlled phase, eligible participants will have a 2-in-3 chance of receiving the investigational medication and a 1-in-3 chance of receiving placebo (they both look alike and are dosed the same, but the placebo contains no actual medicine).
All eligible participants will receive the investigational medication in the long-term extension phase, which begins after the first 18 months of the study.
How will participants receive study medication?
Study medication (investigational medication or placebo) will be given by monthly intravenous infusions (a slow injection into a vein).
How often will participants visit the study center?
Eligible participants will need to visit the study center once or twice a month. There will also be times they need to speak by telephone to study personnel at the study center.
What will happen during study center visits?
Several tests and assessments will be performed to monitor the participant’s health. These may include:
Questionnaires and interviews about how the participant is thinking, how they are able to perform their daily activities, and how they are feeling
MRI (magnetic resonance imaging) scans, to produce detailed images of the brain
PET (positron emission tomography) scans to look at amyloid plaques (abnormal deposits) in the brain; everyone will have one PET scan – performed at one of their screening visits – but only some participants will have more than one
Electrocardiogram (ECG; a test of the electrical activity of the heart)
Measurements of vital signs (blood pressure, heart rate, breathing rate, and temperature, etc.).