A Neurology journal study reveals that only a fraction of Alzheimer’s patients qualify for Eisai’s Leqembi and Biogen’s Aduhelm. Less than 10% of those with early-stage conditions might receive these drugs due to stringent trial criteria. Data from the Mayo Clinic Study of Aging showcased how pre-existing health conditions barred many from eligibility. While trials prioritize safety, this limits access for numerous patients in need.
The study, published in Neurology, exposes a disheartening reality—Eisai’s Leqembi and Biogen’s Aduhelm may reach only a small fraction of Alzheimer’s patients. Less than 10% with mild cognitive impairment or early-stage disease might access these groundbreaking drugs due to strict trial parameters. These drugs aim to slow Alzheimer’s progression but face a critical accessibility hurdle highlighted by the Mayo Clinic Study of Aging. The balance between trial safety measures and broader patient access remains a challenge.
The study, conducted by researchers examining data from the Mayo Clinic Study of Aging cohort, sheds light on the stark contrast between the stringent criteria used in drug trials and the reality of patients’ broader health conditions. Clinical trials often prioritize robust candidates with minimal pre-existing health issues to minimize the risks of adverse reactions. However, this approach, while essential for safety during trials, inadvertently limits access to treatment for a significant portion of the population.
Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine, emphasizes that clinical trial criteria occasionally extend into clinical practice, excluding many individuals in need of treatment. Dr. Vijay Ramanan, a co-author of the study from the Mayo Clinic, points out that while clinicians may use trial criteria as a reference, it restricts the number of eligible candidates in real-world scenarios.
The study focused on 237 older adults meeting the FDA criteria for the drugs, including mild cognitive impairment or mild dementia, along with amyloid plaque buildup in brain scans—a hallmark of Alzheimer’s. Yet, many of these individuals also had conditions like cancer, heart problems, diabetes, or obesity—factors that barred participation in the initial drug trials.
When the researchers removed individuals with these health conditions from their cohort, the study revealed that only a small percentage—8% for Leqembi and 5% for Aduhelm—would have met the criteria for prescription.
Dr. Espay stresses that while these findings provide insight into the real-world proportion of eligible patients, they don’t necessarily imply that all physicians will strictly adhere to trial data when considering treatment options for Alzheimer’s.
Dr. Stephen Salloway, a neurology professor at Brown University, emphasizes the importance of careful patient selection in trials to identify those most likely to benefit from treatment. He urges healthcare providers to guide patients and families in weighing the risks versus the potential benefits of new medications.
The drugs, while offering hope, come with potential side effects ranging from mild issues like headaches and nausea to more severe risks such as brain swelling and bleeds. This led to Leqembi receiving the FDA’s strongest safety warning label upon approval due to the risks of seizures and fatalities.
Dr. Ramanan highlights the study’s limitation regarding participant demographics, mostly comprising white individuals, emphasizing the importance of assessing eligibility in older Black and Hispanic populations, who are more prone to Alzheimer’s yet underrepresented in clinical trials.
Donna Wilcock, director of the Center for Neurodegenerative Disorders at the Indiana University School of Medicine, views these drugs as the beginning of disease-modifying therapies for Alzheimer’s. She anticipates that as researchers gain more insight, a broader population should meet the criteria for treatment.
Overall, the study unveils a concerning disparity: limited access to potentially transformative Alzheimer’s drugs. Stringent trial criteria exclude a vast majority—less than 10%—of eligible patients from receiving Eisai’s Leqembi and Biogen’s Aduhelm. While trials prioritize safety, real-world applications face challenges ensuring broader accessibility. Patient selection criteria need careful consideration to balance safety concerns and broader drug access. As research progresses, bridging this gap becomes crucial to empower more individuals affected by this devastating disease with potentially life-changing therapies.