Investigating the Miracle Biologic Lecanemab for Alzheimer's Disease - Part 2

Lecanemab’s effectiveness evidence base

Okay, folks, let’s start from…..the start. We two geezers like having our ducks lined up before commenting, as you all know from the Antivirals and Comirnaty series of posts. So the start of the line-up is: how many and what investigations were carried out on the wonder Monoclonal Antibody (MAB) Lecanemab for Early Alzheimer's Disease (AD)? 

The Japanese regulator PMDA provides the answer:

As usual (you have to get used to it), we have the nth acronym: OLE, in this case—open Label Extension.

We have phases I, II, and III trials; somehow, the open-label extension is tucked into the last two, 201 and 301. 

The sobriquet “core” is strange. Some pharmaceutical companies use the term “pivotal” when they propose the trial, which, according to them, best supports their request for licensing. 

Regulators and pharma have long tried to standardise their lexicon, but there may be the odd slip. We assume “core” means “pivotal”. Strange that a phase II trial should be called that, but let’s stop splitt…