Clinical Study on a Monoclonial Antibody that fights Alzheimers: Getting a Step Ahead of Alzheimer’s
Teryn James Ph.D. (l-r), a researcher with the WI Alzheimer’s Disease Research Center and Dr. Shenikqua Bouges are working together to recruit participants in the AHEAD study.
Part 2 of 2
By Jonathan Gramling
Growing up in St. Kitts, one of the Leeward Islands in the Lesser Antilles in the Caribbean, Taryn James Ph.D. was exposed to a lot of traditional medicines. Her curiosity about how the medicines work led to her obtaining a Ph.D. in Pharmacology and now being a researcher for the Wisconsin ADRC.
Currently James and her colleague, Dr. Shenikqua Bouges, are working on a trial study for a drug called lecanemab which has shown promise in interrupting the build-up of plaque in the brain, one of the main causes of Alzheimer’s disease.
“When it comes to Alzheimer’s disease, the antibody targets the protein called amyloid-beta that builds up in the brain,” James said. “There are two different proteins that it targets. One is amyloid-beta and the other abnormal tau. This specific drug targets the amyloid-beta that leads to plaque formation in the brain. These plaque can inhibit how the brain functions. There is a step-ladder process that occurs in this plaque formation. And lecanemab is designed to bind to the amyloid-beta in one of those steps to prevent the other steps from occurring. The company that developed the drug shows evidence that it can bind to different types of amyloid-beta, even the plaques. It should help prevent the plaques from developing. It binds to what is considered the most toxic element in the brain. It helps remove that.”
The drug that James is doing a trial on is CLARITY AD. Like drugs that were developed quickly to combat COVID-19, this drug also received fast-track approval.
“In that trial, they saw that people who were on the drug versus the placebo had less decline in their cognitive skills than the ones on placebo,” James observed. “There was a 37 percent less decline in cognitive ability. Based on the data from the trials, it was approved by the FDA in the accelerated pathways. Druga are approved for that pathway if they meet an unmet benefit. It is fast tracked if it is a terrible disease and there is nothing that can be done for it and then you have this drug that is shown to be causing changes. You can apply to get your drug approved for that pathway. In that pathway, the FDA is going to use a measure that will show the drug will be effective. However, to get full approval, you have to show more of a clinical benefit. Although there was a benefit shown to people who are on the drug, they still want to get traditional approval of the drug as well.”
In essence, James is working on the trials for the traditional approval of the drug.
“The trial that we are currently doing at UW-Madison is testing the same drug using the same dose in people who are not clinically diagnosed with Alzheimer’s,” James said. “That means that they don’t have symptoms that are attributed to Alzheimer’s. However, we have to do a blood test to tell us if they potentially can have the amyloid build-up in their brain. As a result of that blood test, it will be determined if they can enter the trial. Based on those results, we will do a brain scan to see if they have the amyloid build-up. It’s called the AHEAD study. It’s not an acronym. The reason it is called AHEAD is because they are trying to get ahead of Alzheimer’s. We want to see if we can remove this amyloid and stop people from deteriorating to where they have memory symptoms from this amyloid build-up. We are trying to slow up that change. Based on the field of Alzheimer’s research, we believe that once you start having these memory changes, you can’t slow down the disease. It just becomes progressive and your memory gets worse and worse until the person ultimately declines from Alzheimer’s.”
Quite possibly — in addition to diet and exercise — this drug could be a new weapon in the fight against Alzheimer’s disease.
“We call them modified therapy for Alzheimer’s disease,” James said. “If you do have Alzheimer’s and you take that type of medicine, you won’t decline as fast is what the data from the trial is showing. But if we can help those who don’t yet have memory symptoms with the drugs, that is why it is called disease modifying therapy for those with Alzheimer’s. It is the first of its kind being tested. By removing this amyloid and people don’t have symptoms, you can slow it down. I must tell you that there are other drugs, there are many different kinds of monoclonal antibodies that are developed to target the amyloids. There are other companies that have similar drugs that are in various stages of clinical trials and actually by the same company. The company that has the drug is called Eisai and Biogen who came together to develop and manufacture the drug. They had a monoclonal antibody approved that is already on the market. Alzheimer’s disease treatment is looking more promising.”
James and Bouges are focusing their recruitment efforts on African Americans and other people of color who are often underrepresented in medical trials to ensure that the drug will impact Alzheimer’s disease among these underrepresented populations.
“The AHEAD study is a four-year commitment,” James said. “They get compensated $50 for each meeting. They also need a study partner. That is someone who is familiar with the person receiving the drug who will be able to answer questions about their daily activities and how any of that has changed since they have been in the trial. They are also compensated. It’s a two-part trial. There is an intermediate level where there is an intermediate-level of amyloids in their brains will receive infusions every four weeks. People who have a higher build-up of the amyloid will receive infusions every two weeks. In the initial phases of the study, they need to come to UW-Madison for the infusions. After completing 16 weeks in the trial, they have the option of getting these infusions at home. Someone will come inn and administer it. The drug is given as an IV infusion. It’s not a pill.”
By getting involved in the AHEAD study, you just might save yourself — and others you know — years of painful decline due to Alzheimer’s disease.
For more information about the AHEAD Study, please visit AHEADStudy.org/LearnMore or call 1-800-AHEAD-70 (1-800-243-2370).