We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it.  

But wait, there’s a shiny new anti-amyloid drug, lecanemab!  (No it’s not just the French version of Aducanumab).  

In an article in the NEJM (a published article this time, wonder of wonders!) lecanemab was shown to slow the rate of cognitive decline by 0.45 points on an 18 point cognitive scale compared to placebo.  Wow!  Wow?  Wait, what?  

On today’s podcast we talk with Jason Karlawish, who we’ve had on previously talking about his book The Problem of Alzheimer’s and with Aaron Kesselhim, to discuss FDA approval of Aducanumab, as well as frequent guest and host Ken Covinsky.  

They debate today’s central question: is it time for geriatricians to get on board with lecanemab?  Along the way we address:

• Is this degree of slowed cognitive decline meaningful to patients or care partners?
• What about the burdens, risks, and harms? Every 2 week visits for infusions, regular monitoring for brain swelling and bleeding, case report level risk of death?
• Did the study do enough to address issues of inclusion and diversity by age, race and ethnicity, and multimorbidity?
• What does this study say about the amyloid hypothesis?
• Should the FDA approve, and under what conditions?

Their answers may surprise you.  

As a preview of final thoughts at the end of the episode, Ken and Jason agree that the FDA should approve lecanemab conditional on a post-approval monitoring system and public access to study data, geriatricians should be prepared to have thoughtful conversations with patients about the risks and benefits of lecanemab in view of their values and priorities, and ultimately, that geriatricians should be open to prescribing it. 

Wow!

The times, they are a changin.

-@AlexSmithMD