The recent approval of Leqembi (lecanemab-irmb) by the U.S. Food and Drug Administration as a treatment for Alzheimer’s disease (AD) marks the first amyloid beta-directed antibody that slows the progression of the disease.
Physicians at the Alzheimer’s Disease and Memory Disorders Center (ADMDC) at Baylor College of Medicine know firsthand how this drug works and played a role in bringing it to full FDA approval. They are also continuing research to find ways to use this therapy in the first stages of AD, before symptoms are present.
“The current FDA approval is for use in people who are diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Certain tests are needed to show the presence of amyloid plaques before being approved for the use of the drug,” said Dr. Melissa Yu, professor neurology and co-director of the ADMDC.
Amyloid plaques are a collection of misfolded proteins that accumulate in the spaces between nerve cells. It is believed to play a key role in the development of AD.
“Our Center here at Baylor is ready to prescribe the drug, and several infusion centers across Houston are ready to administer the infusion therapy. There are benefits to this treatment but also risks that should be weighed with your doctor when making the decision to begin treatment.”
Baylor physicians were a part of the Clarity AD clinical trial that looked at the efficacy and safety of this drug. The findings showed a delayed progression of the disease but also pointed out some side effects such as risk of infusion reaction, which is treatable, and bleeding or swelling in the brain.
“The treatment does not completely stop or reverse the disease. It slows progression by triggering the body to remove the amyloid from the brain,” she said. “That is why we are currently enrolling for a research study to understand the effects of this drug on people who are not yet showing symptoms but are at high risk for the disease.”
Yu is referring to the AHEAD study. It is believed that amyloid plaques begin to form up to 20 years before any sign of the disease is present. The AHEAD study is looking to identify those at high risk for AD and begin treatment to lower the risk of memory loss at later stages of the disease. As Yu stated, this drug does not stop the disease, but if the accumulation of amyloid plaques is treated in these first few decades before symptoms, researchers believe it could potentially have an even greater impact on slowing memory loss.
“We are recruiting healthy people ages 55-80. We also encourage people of every race and ethnicity to take part. When we have a more diverse group of study participants, we have a better idea of how this drug affects the larger population,” Yu said.
“Seeking help from a doctor and being able to identify and treat Alzheimer’s disease and other neurological conditions as early as possible is key,” Yu said. “As more join these studies looking to start treatment as early as possible, we are learning more about this disease and how best to address the progression and maintain the best quality of life as possible for those living with AD.”
By Graciela Gutierrez