Two patients die in clinical trial

Larrytherunner

An 65 year old woman and an 80 year old man, both who were participating in the Biogen sponsored clinical trial for the drug lecanemab, have died. This is another one of the drugs designed to remove amyloid-beta from the brain. Both patients were shown to have widespread cerebral amyloid angiopathy (CAA).

The woman suffered a stroke as well as brain swelling and bleeding. The man's death was linked to lecanemab and a blood thinner.

There seems to be a great deal of risk in taking this drug, and the benefits of this drug in the clinical trial have been shown to be small. I think this is going to mark the end for another highly promoted Alzheimer drug by Biogen.

https://medicalxpress.com/news/2022-11-death-trial-experimental-alzheimer-drug.html

mrl

Wow! Thank you Larry for this info.

Michele

M1

The Wall Street Journal is reporting 27% slowing of cognitive decline compared to placebo over 18 months, but high side effects including brain bleeds and edema.  I didn't get to read far enough to see if they attribute the deaths entirely to the study drug.

Ed1937

Very interesting. When you have stuff like that, it seems it would hinder getting enough people to take part in these things.

Lane Simonian

You would think these deaths would end Biogen and Eisai's lecanemab program, but I have little faith in the FDA's decision making abilities these days.  Medicare may be the one to say no.  

Eisai claims the deaths were not due to lecanemab, but provides no evidence to back this assertion.

In addition, the phase 2b trials for lecanemab showed almost no benefit for non-APOE4 carriers.

Change from Baseline with Placebo

.146

Change from Baseline at Highest Dose (biweekly)

.135

Lecanemab did slow down progression in APOE4 carriers, but the highest dose given biweekly was discontinued part way through the trial by European regulators due to risk concerns so the last figure has to be taken with a grain of salt.

Change from Baseline with Placebo

.180

Change from Baseline with Higest Dose Monthly

.139

Change from Baseline with Highest Dose (biweekly)

.096

https://www.alzforum.org/news/conference-coverage/second-look-ban2401-data-still-positive-despite-snafu

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053280/ (table 16 in supplementary material)

Lecanemab only helps APOE4 carriers during the early stages of Alzheimer's disease, but poses a risk of brain bleeds and swelling for this group that can (it appears) lead to death.

Paris20

As I was driving to visit my husband at his nursing facility, I listened to an interview with one of the researchers involved in the development of this drug. He admitted that it appears to help only those at the very beginnings of the disease. Then he said, «It would be best if we could use the drug for people who show no symptoms yet.». Huh? I suppose some people who can be shown to have a genetic predisposition for dementia could benefit, but that is a small number. It shows that we are far from truly helping dementia patients.