By Marti Webb Slay
Treatment options for Alzheimer’s have expanded in the past year, with the FDA approval of lecanemab (Leqembi®) in July 2023 leading to Medicare extending coverage for the drug, offering new hope for the nearly seven million people in the U.S. living with the disease. In addition, blood-based biomarkers can now identify the presence of the abnormal Alzheimer protein (amyloid beta) and evidence it is causing damage to the brain, more easily providing a definitive diagnosis.
The UAB Brain Aging and Memory Clinic has been expanding in anticipation of the new drug’s approval, and they are joining 75 research locations across North America to enroll participants in the AHEAD study, which will test lecanemab in people without noticeable symptoms to see if the disease can be delayed or even prevented. Discovering a treatment that targets brain changes early may mean one day preventing memory loss.
“We’ve expanded our clinic in preparation of the anti-amyloid infusion drug,” said Marissa Natelson Love, MD, associate professor, Department of Neurology at UAB. “We now have our own pharmacists, pharmacy techs, social workers, six nurse practitioners, two nursing care coordinators and two care managers who are managing the folks on the anti-amyloid drug. We are actually ahead of the curve in the US to be able to get the drug to people.”
Love said up to 120 symptomatic patients were in the process of being approved for the new drug, and more than 10 are actually receiving weekly infusions. In addition to treating these patients who have been diagnosed with Alzheimer’s, the clinic is seeking patients to enroll in the AHEAD Study.
“We know from prior studies that the amyloid plaque, which we refer to as the toxic brain plaque, can build up for 15 to 20 years before people have any symptoms. At some point, there is a switch that happens, and it begins to break down brain cells,” Love said.
Now that it is proven that lecanemab slows the progression of Alzheimer’s in people already diagnosed, the AHEAD Study will test whether lowering amyloid before symptoms appear can help delay the onset of those symptoms.
“We are looking for people ages 55 to 80 who are asymptomatic, meaning with no cognitive impairment,” Love said. “We screen them with a blood test to look for the toxic amyloid brain plaques, and if they have evidence of amyloid plaques, then we move on to determine how much they have, by doing an amyloid PET scan. If they have a medium or moderate amount, they move into the A3 group and get lecanemab once a month. If they have a high or severe amount of plaque, they go into the same regimen that people who are symptomatic get, and they get it every two weeks. We can’t tell exactly when people will become symptomatic, but the previous study shows that the higher amount of plaque you have, the faster you decline. So that’s why they will get the more aggressive treatment.”
AHEAD is a randomized, controlled trial, so one group of people will get placebo, and all participants will be followed for several years to see if the treatment prevents the onset of Alzheimer’s symptoms.
Testing of a different anti-amyloid drug, donanemab, indicated that at some point patients may be able to come off the drug when amyloid levels drop. “They actually showed that 30 percent of people in the trial had no amyloid after six months. It was up to 70 percent by 18 months,” Love said. “This is something the field will have to come to consensus on: how often to check to see if we have actually eliminated the plaque and how often we need to give a maintenance drug.
“Most people who are interested in participating in the study have family members with Alzheimer’s and want to get ahead of the disease, if possible. We want to include a higher representation of people who are Black and Hispanic. This is different from the previous studies, which have been 95 percent white. We typically try to get 50/50 men and women, although in general we’ve had fewer men show up at our site.”
Every visit for the study includes a small stipend and a meal. The infusions typically last an hour, after the first day, when patients are monitored for several hours after receiving the drug. Those who are interested can visit the website AHEADstudy.org or call 1-800-AHEAD-70. The website takes them through pre-qualification questions. If you qualify, you’ll be referred to a local research coordinator.
