Investigating the Miracle Biologic Lecanemab for Alzheimer's Disease - Part 4

Lecanemab’s Phase 3 trial

Now we come to the Phase III trial, the last in the Eisai evidence development plan submitted to regulators.

There are four main phases of clinical trials – Phase 1 trials are the earliest phase trials, and Phase 3 are later phase trials that compare new treatments with the best currently available treatment to find out which treatment works better,  more about the adverse effects and should include an assessment of quality of life. 

Study 301 is “A randomized, double-blind, parallel-group trial conducted at 235 study centers in Japan and other countries to evaluate if lecanemab was superior to placebo in terms of slowing disease progression in patients with early AD (target sample size, approximately 1,766 subjects)”.

The duration, including the OLE phase, was 60 months.

Eisai Ltd used a single schedule of 10mgs/Kgs twice a week, presumably as this was shown in Phase II as the less toxic regime. They also changed the MAB commercial name to BAN2401, probably to suit the US market. So, the…