FOCUS ON : RESEARCH
New Hope for Alzheimer ’ s Patients
BSW AT & T Memory Center director Cindy Marshall , MD , answers questions about new FDA drug approval .
n July 2023 , the U . S . Food and Drug Administration ( FDA ) granted traditional approval to lecanemab ( brand name Leqembi ), a drug for the treatment of early Alzheimer ’ s disease . Cindy Marshall , MD , medical director of Baylor Scott & White AT & T Memory Center , shares what this means for patients and families facing a neurodegenerative disease diagnosis .
What is lecanemab and how does it work to fight Alzheimer ’ s disease ?
The FDA approval of lecanemab is a significant development in the fight against Alzheimer ’ s disease . It is the first drug to be approved that has been shown to slow the progression of the disease in people with early Alzheimer ’ s by reducing amyloid beta plaques in the brain . While not the only cause of Alzheimer ’ s disease , amyloid plaques are believed to be a major contributor to it .
Lecanemab is administered twice monthly through intravenous infusion , and while it is not a cure for Alzheimer ’ s , it could offer hope to people with the disease and their families .
How did Baylor Scott & White prepare for the approval of this new drug ?
While other institutions are focused on bench research , Baylor Scott & White has robust efforts in clinical research , which brings new drugs and therapies , like lecanemab , directly to patients .
Our team has been gearing up for this moment since last fall . We knew there was a strong likelihood of lecanemab being granted accelerated approval , a pathway by which the FDA expedites the approval of drugs for serious conditions , given promising results in initial clinical trials . As anticipated , lecanemab secured this accelerated approval in January 2023 . To provide swift access for our patients , we conducted preliminary screenings of all individuals under our care at the Memory Center . This enabled us to promptly extend this treatment option to those eligible .
In March 2023 , we were able to access outside infusion centers as we worked through pharmacy and therapeutics approval at Baylor Scott & White and successfully administered the first infusion . Due to our ability to offer this drug after accelerated approval , we are very much ahead of the curve and currently have about 50 patients who are at some stage of infusion . We anticipate being able to start infusing at Baylor Scott & White this fall .
How does this impact the work at BSW AT & T Memory Center ?
A big part of what we do is evaluate and assess memory loss in patients to determine if they have a memory disorder . Lecanemab is for those in the beginning stages of disease — which is often when patients first come to us for answers . This is a great intersection of our work to provide an accurate diagnosis with an immediate option for a treatment that slows disease progression .
What patient populations are most likely to benefit from the new drug ?
To be eligible for lecanemab , patients must have mild cognitive impairment or mild Alzheimer ’ s dementia with confirmed amyloid pathology through PET scan or spinal fluid . Patients must also be free of certain medical conditions , such as recent stroke or history of multiple brain microhemorrhages .
The management of the infusions is complex and requires extensive coordination with neuroimaging facilities and infusion centers . This drug class carries risk of brain edema ( swelling ) and bleeding . Baylor Scott & White is committed to the safety of patients receiving lecanemab and the clinic follows the recommended MRI schedule to monitor for these potential side effects .
Is this the advance you and your colleagues have been waiting for , or is it the first step ?
It ’ s step one . We ’ ve waited a very long time to have treatments — this is my 20th year of practice — and no one ever thought it would be this long . It ’ s the promise of things to come — we also expect the FDA to approve another amyloid antibody compound later this year . I think it ’ s like the first cancer drug or the first hypertension drug — we start with one type and then over time , it ’ s probably going to be a layering of medications that someone takes for Alzheimer ’ s disease . I ’ m incredibly grateful to those who dedicated their work to developing treatments and to all those who have supported the work of the Memory Center . Until we have better treatment options or a cure , our work to support patients and families throughout their diagnosis is incredibly meaningful and impactful .
In addition to evaluating patients for memory disorders , BSW AT & T Memory Center provides comprehensive support and care to patients and their families . Philanthropic support helped create BSW AT & T Memory Center and provides ongoing support each year . For more information on how you can support this important work , please contact Tim Moore at 214.820.7877 or Timothy . Moore @ BSWHealth . org .
Dr . Cindy Marshall , medical director of Baylor Scott & White AT & T Memory Center
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THE COMPASS / BAYLOR SCOTT & WHITE FOUNDATION NEWS / FALL 2023