- Last year, federal regulators approved two new monoclonal antibody treatments for Alzheimer’s disease.
- However, researchers report that only a small percentage of people are eligible to be prescribed the two drugs in the early stages of the disease.
- Experts say the lack of qualifications is a serious problem because it is important to treat people with dementia as early as possible.
Only a small percentage of patients with early-stage Alzheimer’s disease are candidates for treatment with new monoclonal antibody drugs.
according to it the study published in today’s magazine neurology.
Researchers report in their studies that because the number of people enrolled in clinical trials for the drug is so small, only a small minority meet standards of treatment with drugs such as aducanumab and lecanemab.
“These new treatments for Alzheimer’s disease are expected to slow the progression of the disease in many people, but the drug has only been studied in patients with the earliest forms of Alzheimer’s disease. The fact remains that there are Maria VasilakiAn epidemiologist at the Mayo Clinic in Rochester, Minnesota and author of the study, said in a press statement.
“The clinical trial inclusion and exclusion criteria that have led the FDA to accelerate approval of these treatments determine how people are encouraged or discouraged from receiving any of these treatments. Our study suggests that only a small fraction of older adults with early cognitive impairment due to Alzheimer’s disease may be eligible for treatment with monoclonal antibodies directed against amyloid-β in the brain. I’m assuming it’s possible,” she added.
Researchers tested 237 people aged 50 to 90 who were experiencing mild dementia or cognitive impairment.
Brain scans of the subjects also showed an increased amount of amyloid-beta plaques.
The researchers then evaluated these people against the inclusion and exclusion criteria for the monoclonal antibody drugs lecanemab and aducanumab.
The researchers found that 47% of participants met the inclusion criteria for the lecanemab trial, but only 8%, or 19, were found to be eligible after applying the exclusion criteria. .
Exclusion criteria included health problems such as cardiovascular disease, stroke, history of cancer, and brain injury.
In the case of aducanumab, considering the inclusion and exclusion criteria, only 5% of the trial population, or 12 people, would have been eligible to participate in the trial. Exclusion criteria for aducanumab also included health factors such as uncontrolled hypertension.
Because the FDA’s approval of the drug is based on clinical trials, researchers say it is likely that only a small percentage of people with Alzheimer’s disease will be able to use the drug.
“Our findings indicate that a small proportion of patients with early Alzheimer’s disease may be eligible for treatment, primarily due to chronic health conditions and It’s due to brain scan abnormalities that are common in older people,” Vassilaki said.
“In general, clinical trial participants are healthier than the general population. Additional studies are needed to examine the safety and efficacy of monoclonal antibodies that target amyloid-beta plaques,” she added. .
Dr. Sharon ShaHe, a clinical professor of neurology and director of the Department of Memory Impairment at Stanford University in California, says the timing of treatment with monoclonal antibodies is critical.
“Amyloid is deposited 15 to 20 years before clinical symptoms (often amnesia), so early treatment is key to maximizing the drug’s effectiveness,” she said. . medical news today.
“The approval of these drugs is based on clinical trials in people with early stage disease. may change,” Sha added.
Aducanumab is
David MerrillA geriatric psychiatrist and director of the Pacific Brain Health Center at the Pacific Neuroscience Institute in California, argues that the majority of patients are unlikely to benefit from these monoclonal antibody treatments. ing.
“If you’re the average patient who comes to a clinic wanting this treatment, it’s highly unlikely that you’ll qualify for it to be offered the way it’s labeled,” he said. . medical news today. “This is downright problematic and shows that much more needs to be done and done to help people with Alzheimer’s disease. These are not the treatments for the vast majority of patients.”
“Amyloid removal may be dangerous for the majority of people with Alzheimer’s who have microbleeds in the brain and are otherwise unstable,” Merrill explained. “These antibody infusions have a role in treating Alzheimer’s disease, but it is a real wake-up call that this is not the end of the story and we need to keep working hard to figure out what could be causing it. It not only cleared the amyloid in the brain, but also addressed the problem. ”
The researchers argue that their study highlights the importance of further research with a wider population.
Black and Hispanic people have allegedly been underrepresented in Alzheimer’s trials, even though they have Alzheimer’s disease.
Sha said this is an ongoing challenge in clinical trials.
“It’s important to involve a broad and diverse population in trials to better understand the benefits of these drugs for different types of patients,” she said. “However, people of lower socioeconomic status, which often affect certain racial and ethnic groups, are more likely to be at risk due to lack of access to clinical trial centers (distance, work, caregiver support, etc.) or health complications. As a community, we are looking at ways to involve the wider community in both clinical trials and clinical care to find out if these treatments will help these patients. , need help.”