Witnessing a breakthrough: physicians find hope in new Alzheimer’s drug
For neurologists working with patients with Alzheimer’s disease, the road to actual treatment options has been long and paved with setbacks.
But that is changing for some patients. The Food and Drug Administration recently granted full approval to Leqembi® (lecanemab), the first disease-modifying treatment fully approved for patients in the early stages of Alzheimer’s disease. The development of this new drug offers hope to patients and may have lasting impacts on how physicians approach treatment.
“There have been many negative trials,” said Dr. Erik Musiek, Washington University neurologist at Barnes-Jewish Hospital. “We’ve only been able to treat some symptoms related to Alzheimer’s disease, not the disease itself.”
Alzheimer’s disease is the most common form of dementia for patients 65 and older, affecting roughly six million people in the United States alone. According to Musiek, and Dr. Brent Huffman, BJC Medical Group neurologist at Missouri Baptist Medical Center, the FDA approval is a big step forward in Alzheimer’s treatment.
“[Leqembi’s approval] is a massive development,” Huffman said. “It’s really opened the door to what is a disease-modifying therapy rather than a symptomatic medication like we’ve been using for the last 20-plus years.”
Physicians and researchers at Washington University School of Medicine’s Charles F. and Joanne Knight Alzheimer Disease Research Center (Knight ADRC) in St. Louis were involved in the clinical trials evaluating Leqembi, in which they enrolled participants with the most common form of Alzheimer’s disease. In August, BJC HealthCare and Washington University School of Medicine became among the first health care providers in the region evaluating patients and providing the drug to those who are eligible.
“Right now, we’re in the very beginning stages,” Huffman said. “Part of that is predicated on insurance; insurance companies needed to determine what they were going to cover. The first out of the gate was traditional Medicare. As other companies get on board it will start to expand.”
Alzheimer’s is characterized in part by the collection of a protein called beta amyloid within the brain. Abnormal levels of this naturally occurring protein clump together to form plaques that collect between neurons and disrupt cell function. Leqembi is the first fully-approved drug clinically shown to remove amyloid plaques from the brain and slow the progression of the disease. Patients in clinical trials who took Leqembi showed a 30% slower progression of their Alzheimer’s, as seen via imaging and specific cognitive tests.
“These plaques aren’t everything to do with Alzheimer’s, but they’re a major part,” Huffman said. “And we now have a medicine that has been very effective at removing beta amyloid from the central nervous system, if used in the very early stages of the disease.”
Huffman and Musiek both stressed that Leqembi cannot help patients regain cognitive function that’s already been lost, and that not all dementia patients are eligible to receive Leqembi. Right now, the drug is only approved for patients diagnosed with mild cognitive impairment from Alzheimer’s disease, as well as mild Alzheimer’s dementia. The diagnosis must be confirmed through cognitive assessments, blood tests, and more specialized tests, which can include lumbar puncture (also known as a spinal tap) or a special scan called a positron emission tomography (PET) scan. About 15-20% of patients with Alzheimer’s disease may be eligible to receive the drug. Patients also need access to a hospital with advanced imaging and an infusion center to receive the drug. The drug requires ongoing infusion.
Patients eligible to receive Leqembi through BJC must first be evaluated by a general neurologist, who, if appropriate, may refer the patient to the Memory Diagnostic Center (MDC) for further evaluation. Once considered a good candidate – and the patient consents – they can visit one of eight BJC locations in the area to get the treatment. These include Alton Memorial Hospital, Barnes-Jewish Hospital, Barnes-Jewish St. Peters Hospital, Missouri Baptist Medical Center, Missouri Baptist Medical Center - Sunset Hills, Missouri Baptist Sullivan Hospital, Memorial Hospital and Parkland Health Center.
Musiek and Huffman said it’s important for patients and caregivers to weigh the possible benefits of starting Leqembi against its side effects. The most serious reported side effect is amyloid related imaging abnormalities (ARIA), in which temporary swelling or small bleeds can be seen on brain scans. Approximately 25% of patients report this side effect, though only 2-3% reported any associated symptoms.
“The most important thing is that the patients are evaluated by a qualified team of specialists with access to advanced imaging technology,” Musiek said. “It’s a pretty low rate of serious side effects, but there may be patients for whom the risks outweigh the benefits.”
Musiek said the development could lead to a much-needed shift in the way patients and health care providers think about Alzheimer’s disease.
“I think it’s a big deal,” Musiek said. “In the past there was no treatment for the underlying disease. We could only alter symptoms, and that affected how we thought about the disease. Now we need to be more aggressive about diagnosis and identifying patients who may benefit from this therapy.”
Patients or caregivers who want to know more about whether they may be eligible for Leqembi should first speak with their primary care physicians or neurologist.
To learn more about potential treatment with Leqembi, call 314-362-9355.