About This Trial
About Alzheimer's Disease
Alzheimer’s disease is the most common cause of dementia (progressive decline in memory and other cognitive and behavioral domains severe enough to affect function in daily life). The memory loss, mood changes, problems with communication, and difficulty looking after oneself typically seen in Alzheimer’s can be easily recognized. The EARLY Trial is looking for people ages 60–85 who have normal thinking and memory function, but who may be at risk for developing Alzheimer’s disease dementia.
Technological advances have made it possible for researchers to measure beta-amyloid in the living brain. Beta-amyloid is a protein that can form deposits called amyloid plaques. Evidence shows that the formation of amyloid plaques is the earliest identifiable change seen in the brain prior to the development of symptoms of Alzheimer’s disease. In fact, amyloid plaques can be seen in the brain 10–15 years before any noticeable outward symptoms of Alzheimer’s disease. Please see the About Amyloid Plaques page on this website for more information on the relationship between amyloid plaques and the symptoms of Alzheimer’s disease.
About the EARLY Trial
The EARLY Trial is researching the risk associated with the buildup of amyloid plaques in the brain, and will use the latest technological advances to measure beta-amyloid in the brain. Stopping or slowing down amyloid plaque formation in the brain may delay memory loss associated with Alzheimer’s disease. It may also help control other changes in the cells of the brain that contribute to the disease. The purpose of the EARLY Trial is to evaluate the safety and efficacy of an investigational medication in people at risk of developing Alzheimer’s disease dementia.
Currently there is no cure for Alzheimer’s disease, and there are no treatments proven to delay early memory loss associated with Alzheimer’s disease. It is important that we conduct research into memory loss associated with Alzheimer’s disease. We hope you will consider taking part!
You may be able to take part in the EARLY Trial if you:
- Are age 60 to 85 years
- If you are age 60 to 64 years, you will need to have a parent or sibling with Alzheimer’s disease, and/or
- Have been told that you are at risk for developing Alzheimer’s disease (that you have the APOE ε4 gene or a proven buildup of amyloid in your brain).
- Have normal memory and thinking abilities.
- Even if you are worried you have subtle memory changes, you may still be able to take part. The clinical trial doctor and the study team will work with you to determine if this trial is right for you.
- Have a close friend, relative, or spouse who can come to some trial visits with you
If you take part in the EARLY Trial, your clinical trial doctor will tell you whether you have a buildup of amyloid plaques in your brain. A buildup of amyloid plaques is linked with a greater risk of developing the symptoms of Alzheimer’s disease, but it does not mean that symptoms of Alzheimer’s disease will develop in the next few weeks, months, or even years. If you do not want to know your amyloid status, you will not be able to take part in the EARLY Trial.
Your time in the EARLY Trial
The EARLY Trial has three parts, which will take place over 5 years.
Screening period (first 3 months)
- You will attend 6 visits to see if you qualify for entry into the trial.
Treatment period (4.5 years)
- If you are eligible, you will visit the trial site every 1–2 months during the first 12 months of the treatment period. After that, trial site visits slow in frequency to once every 3 months.
- You will receive either the investigational medication or placebo. A placebo is a tablet that contains no medication. Both tablets will look the same, so you will not know which treatment you will receive.
- Whether you receive the investigational medication or placebo will be decided at random. Neither you, nor your trial doctor/team will know what you will receive.
- 2 out of every 3 trial participants will receive the investigational medication.
- The trial medication (investigational medication or a placebo) will be 1 tablet that you take every morning.
- There is a single visit 1–4 weeks after your last dose of trial medication. Also, you will be contacted by telephone every 6 months for up to 5 years to check on your general health and thinking abilities.
During trial site visits (typically visits should not take longer than 4 hours), you will undergo several assessments:
- Questionnaires about how well you are thinking, how well you are able to perform your daily activities, and how you are feeling.
- MRI scans to produce detailed images that show the structures within your brain.
- PET scan to produce a picture that shows where abnormal proteins associated with Alzheimer's disease (AD) may be in your brain, and/or a lumbar puncture. A lumbar puncture uses a small needle carefully inserted in the back to collect fluid from the spinal canal to test for the same abnormal proteins. A PET scan and/or a lumbar puncture will be performed every 1 or 2 years to determine the amount of amyloid in your brain.
- Blood and urine tests.
- Electrocardiogram (a test of the electrical activity of your heart).
- Physical exams and vital signs (such as blood pressure and temperature).
- Skin exam.