When Barbara Foster, 78, received a flyer about an Alzheimer’s disease prevention study, she was intrigued. She remembered all too well caring for her mother, aunt, and uncle and the challenges they faced when they had dementia. Her aunt became increasingly combative, while her mother became mistrustful. “I don’t want it to be like that for me and I want to know if it’s going to happen,” she said. “I want to be able to make some plans.”
Dorothy Hughes, 82, heard about the same study through her older sister, who was undergoing eligibility screening for the study and asked Dorothy to be her study partner. Her sister didn’t qualify for the study, but Dorothy, who was experiencing minor memory issues and remembered an aunt who she now realizes may have had Alzheimer’s disease, decided to find out if she could participate.
Both women ultimately enrolled in the Anti-Amyloid in Asymptomatic Alzheimer’s (A4) study. “This is the first effort in history to try to prevent Alzheimer’s disease symptoms before they appear,” said Christopher van Dyck, MD, Director of Yale’s Alzheimer ’s disease Research Unit, who is heading the study at Yale, one of 60 sites around the U.S., Canada, and Australia. Dr. van Dyck has conducted many studies involving patients with Alzheimer’s disease and their relatives in order to better understand and treat the disease.
Alzheimer’s disease currently afflicts more than 5 million Americans. There is no cure and no way to prevent it. Many experimental treatments have been aimed at reducing levels of amyloid beta protein, which forms plaques in the brain. But researchers now believe that reducing amyloid in the brain has to be done much earlier in the disease process – several years before symptoms appear - if it is going to help.
The A4 study is a landmark clinical trial for people ages 65 to 85 with normal cognitive function, meaning the ability to learn and remember. Participants undergo PET scans to determine if they have a buildup of beta amyloid in the brain and are therefore at increased risk of developing Alzheimer’s. Those with elevated amyloid levels may be eligible to participate in the clinical trial to test whether an experimental medication slows down cognitive decline. Another part of the study involves using PET scans to detect levels of a protein called tau, which causes “tangles” in the brain that are associated with Alzheimer’s. Yale is one of the first sites in the country to conduct PET imaging for tau as part of this study.
Eligible participants randomly receive either the study medication or a placebo and are followed for about three years, after which they have the option of starting or continuing the medication, depending on which group they were in. “I don’t know if I’ll gain anything because I don’t know if I’m getting the medication,” said Dorothy Hughes, who had never participated in a research study before. But she hopes that the results will help doctors learn more about how Alzheimer’s affects the brain and how it progresses. In the meantime, her participation has heightened her awareness of what Alzheimer’s looks like and she has started doing brain puzzles every day.
Barbara Foster had participated in a research study in the past as a healthy volunteer, but had never taken part in a study involving medication. She had many questions before deciding to take part in the A4 study, and called Dr. van Dyck several times with queries. “I feel like I am getting information and can prepare myself, or even prevent or slow down Alzheimer’s,” she said. She believes people should participate in clinical research not just to possibly help themselves, but for the potential benefits to others.