With the FDA deliberating over a potential new Alzheimer’s treatment, we sought insights from experts on the implementation of a similar medication.
Over the past three years, a new class of Alzheimer’s drugs, the first targeting the disease’s root cause, has sparked a journey marked by hope and setbacks. While these anti-amyloid antibodies initially faced challenges, the tide of optimism has turned as one of the medications, Lecanemab (branded as Leqembi), received full FDA approval in July 2023 and is now more widely used among Alzheimer’s patients. Despite its ability to slow disease progression, Lecanemab presents modest benefits and carries burdensome therapy requirements along with a heightened risk of side effects.
As Lecanemab approaches its one-year mark of approval and with a similar drug, Donanemab, under FDA review, we consulted experts from three prominent medical institutions to understand the demographics of patients receiving Lecanemab and their responses.
Eligibility Criteria and Patient Selection
The criteria for Lecanemab eligibility are stringent, with estimates suggesting that fewer than 20% of patients qualify. Neurologists at renowned institutions such as the Mayo Clinic, Massachusetts General Hospital, and the University of California, San Francisco (UCSF), revealed a consistent screening process. Candidates must be diagnosed with mild cognitive impairment or mild dementia, undergo PET scans or lumbar punctures to confirm the presence of amyloid plaques, and receive MRI screenings for other brain conditions. Genetic testing for the APOE4 gene variant is mandatory due to its association with severe side effects, while patients on blood thinners are typically excluded due to increased bleeding risks. Even meeting all criteria doesn’t guarantee prescription, as individual health factors and accessibility to necessary screenings are also considered. Multidisciplinary panels comprising neurologists, radiologists, psychiatrists, and geriatricians collectively assess each case for eligibility.
Treatment Protocol and Associated Risks
The treatment regimen for Lecanemab demands significant time and financial commitments, with biweekly infusions and regular MRI scans for side effect monitoring. Despite Medicare coverage, out-of-pocket expenses can amount to $6,600 annually. Concerns about adverse effects, particularly amyloid-related imaging abnormalities (ARIA), including brain swelling or bleeding, are paramount. While incidences of ARIA have occurred, severe cases have been rare across medical centers, instilling cautious optimism among physicians.
Benefits and Patient Response
Despite the risks and logistical challenges, Lecanemab offers an average 27% reduction in disease progression without memory improvement. Patients experience a delay in transitioning to more severe stages of Alzheimer’s, enhancing their independence in daily activities. The long-term benefits are yet to be fully realized, as patients typically remain under observation for several months post-initiation. However, initial enthusiasm among patients and physicians underscores the urgent need for effective Alzheimer’s treatments.
One such patient, Helene, diagnosed with early onset Alzheimer’s, embarked on Lecanemab treatment after thorough assessments. Despite logistical hurdles and initial adverse reactions, Helene’s journey with Lecanemab has been promising, with no significant side effects and a halt in disease progression. For Helene and her husband Joseph, the treatment represents hope and extended time together, despite the risks involved.
In conclusion, the arrival of Lecanemab heralds a significant milestone in Alzheimer’s treatment, underscoring the delicate balance between risks and benefits in patient care.
