New York Consortium for Alzheimer’s Research and Education (N.Y.C.A.R.E.)
The New York Consortium for Alzheimer’s Research and Education (N.Y.C.A.R.E.) is the joint effort of the Alzheimer’s Association, New York City Chapter and the Education and Information Cores of the Alzheimer’s Centers — Columbia University, College of Physicians and Surgeons; Mount Sinai Medical Center; and New York University School of Medicine — funded by the National Institute on Aging.
Participating in Research
What is it really like to participate in a clinical research study?
Scientists are working hard to find better treatments and a way to prevent Alzheimer’s disease (AD), but progress cannot be made without volunteers — both those with memory problems as well as healthy elders — to participate in the studies. The benefits of participating in a study may include the possibility of access to treatments not yet commercially available, receiving excellent care, helping the next generation, and knowing one is helping move science forwards.
However, people often have questions: “What will they ask me?” “How much time will it take?” “What actually happens when I go there?” The goals and time commitments vary considerably from study to study, and you need to pick one that fits with your schedule and comfort.
So let us walk you through a research visit for what we call the “A4” study! The A4 study — short for Anti-amyloid Treatment in Asymptomatic Alzheimer’s disease is a clinical trial for those who may be at risk for developing AD and its goal is to prevent memory loss before it occurs.
The following is a description of the way the study is carried out at Mount Sinai Medical Center. Other sites may vary in how they conduct this and other studies.
Finding out if you are eligible. You and your study partner (family member or friend) come to the research center where you will be greeted by the friendly face of a young research coordinator — someone you will come to know very well. We meet in a comfortable carpeted office and appointments are scheduled at your convenience. The coordinator explains the consent form which includes all of the information about the procedures and the risks and benefits, and answers questions you may have. When your questions are answered and you are comfortable with the study, you sign the consent as does the study staff and you receive your own copy. Afterwards, a professional health care provider will draw your blood and the coordinator will give you some paper and pencil type memory and thinking tests. Finally, you meet with one of our doctors, who will ask you some questions and have time to answer yours as well. The screening takes several hours and may need to occur across several visits to be sure you are healthy enough to participate, but there is plenty of time for breaks and lunch.
At these visits, which last several hours, you will have both an MRI (a way to take a detailed pictures of your brain) and a PET scan (a way to detect the presence of plaques in the brain possibly years before one would experience cognitive changes). There is minimal discomfort with having scans, but you do have to lie down on your back inside a large tube and it can be noisy. For the PET scan, an IV line will be started and a radiotracer will be injected into your body and allowed to circulate for about 50 minutes before you are placed in the scanner for about 45 minutes.
Once the scans are read, you and your study partner will meet with the doctor directing the study and discuss the results. If the scan is positive for presence of amyloid plaque, then you are eligible to continue to the treatment phase. If the scan is not positive, then your journey in the A4 study comes to an end. However, it is important to note that in this study neither a positive nor a negative scan result determines that you have or you will develop dementia; rather, a positive scan infers increased risk of developing symptoms of AD.
Initiation Visit and Monthly for Three Years:
Eligible participants begin the treatment phase of the study. Half will be randomly assigned to the placebo group, but by the end of the study everyone will be offered the active treatment. The treatment phase includes monthly infusions (90 minutes) of the study medication solanezumab, with paper/pencil cognitive testing and imaging completed at regular intervals. The study coordinator is always with you, and there is plenty of time for chatting and reading. One of the things people say they enjoy most about research participation is the relationships you develop with the coordinators and doctors.
Remember, not every study is right for every volunteer. Take the time to review what studies are available and ask lots of questions so that you can find a way to participate that works best for you and your family.