By Simon Spichak, MSc | October twenty eighth, 2022
In June, a affected person enrolled within the Part 3 medical trial for experimental Alzheimer’s drug lecanemab skilled mind bleeds and later died. It’s unclear whether or not or not the loss of life is linked to the drug trial.
On the finish of September, Eisai and Biogen introduced that their experimental anti-amyloid drug lecanemab efficiently slowed cognition in Alzheimer’s sufferers, in keeping with knowledge from the Part 3 trials. This week, STAT Information reported {that a} participant within the lecanemab trial handed away.
It’s unclear whether or not or not the loss of life is linked to the drug trial, however considerations have been voiced by trial investigators that the affected person skilled mind bleeds — a aspect impact of anti-amyloid medication — and that these negative effects could have been associated to the affected person’s loss of life.
The trial investigator who initially flagged the loss of life believed that the mind bleeds the affected person skilled have been associated to the drug. Eisai and Biogen disagreed, citing that the affected person had skilled a number of falls, a coronary heart assault, a respiratory an infection, and mini-stroke-like occasion.
The affected person who died was additionally taking a generally prescribed anticoagulant on the time. The circumstances of the loss of life have been investigated, and that in July, a security board overseeing the trial discovered that 3.1 p.c of sufferers on anticoagulants within the research developed mind bleeds: 5 instances extra usually than sufferers who weren’t taking these medication.
Anti-amyloid Alzheimer’s therapies and mind bleeds
Mind swelling and irritation stay a widespread aspect impact of anti-amyloid medication. These mind bleeds — known as ARIA — have an effect on some 12 p.c of research contributors, and are sometimes thought of delicate in that they don’t trigger any signs.
Within the drugmakers’ earlier anti-amyloid drug, Aduhelm, these abnormalities have been extra widespread, occuring in about 40 p.c of contributors. Within the Aduhelm trial, it remained the case that almost all of ARIA circumstances have been asymptomatic. Nevertheless, it’s but unknown whether or not asymptomatic circumstances in the course of the trial could have any lasting impacts for sufferers.
It is going to be difficult to find out whether or not lecanemab straight contributed to the affected person’s loss of life, however the occasion is fueling a dialog in regards to the security dangers linked to anti-amyloids and their negative effects.
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