In the past two years, the Food and Drug Administration has approved two novel Alzheimer’s therapies, based on data from clinical trials showing that both drugs slowed the progression of the disease. But while the approvals of lecanemab and donanemab, both antibody therapies that clear plaque-causing amyloid proteins from the brain, were greeted with enthusiasm by some Alzheimer’s researchers, the response of patients has been muted. According to physicians who care for people with Alzheimer’s, many patients found it difficult to understand what the clinical trials results — presented as “percent decrease in the rate of cognitive decline” — meant for their own lives.
Researchers at Washington University School of Medicine in St. Louis have devised a way to communicate the effects of taking the new Alzheimer’s medications in language that is accessible and understandable to patients and their families. Using data on the natural history of the disease and the magnitude of the drugs’ effects as measured in clinical trials, the researchers calculated how many months of independent living an Alzheimer’s patient could expect to gain by undergoing treatment. The benefits depended on the drug and the severity of the patient’s symptoms at the time treatment began. As a representative example, a typical patient who started treatment with very mild symptoms could expect to live independently for an additional 10 months if treated with lecanemab, or eight months with donanemab.
The study, published Feb. 13 in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, provides crucial information that can help patients and caregivers weigh the benefits against the costs and risks of treatment.
“What we were trying to do was figure out how to give people a piece of information that would be meaningful to them and help them make decisions about their care,” said senior author Sarah Hartz, MD, PhD, a professor of psychiatry at WashU Medicine. “What people want to know is how long they will be able to live independently, not something abstract like the percent change in decline.”
Alzheimer’s patients and their families are faced with the tough question of whether to undergo a treatment that will not make them better. It won’t even stop them from getting worse. At best, treatment with lecanemab or donanemab could slow the inevitable cognitive decline that characterizes Alzheimer’s. Add to this the facts that treatment is expensive, requires biweekly or monthly infusions, and carries risks such as brain bleeds and brain swelling that are usually mild and go away on their own but can, in rare cases, be life-threatening.
But just because the benefits are limited doesn’t mean they are not valuable to patients and their families.
“My patients want to know, ‘How long can I drive? How long will I be able to take care of my own personal hygiene? How much time would this treatment give me?’” said co-author Suzanne Schindler, MD, PhD, an associate professor of neurology and a WashU Medicine physician who treats people with Alzheimer’s disease. “The question of whether or not these drugs would be helpful for any particular person is complicated and has to do with not only medical factors, but the patient’s priorities, preferences and risk tolerance.”