Experimental drug slows Alzheimer’s but also causes deadly side effects

The new experimental drug lecanemab from the companies Eisai (Japan) and Biogen (USA) slightly slows the cognitive decline of patients in the early stages of Alzheimer’s disease, the results of its clinical trial show. The findings were marked as significant, if not historic – given the complete failure to find an effective drug against neurodegeneration for decades.

But on the other hand, lecanemab – a monoclonal antibody given intravenously – also appears to carry risks of serious side effects, even death, due to brain swelling (in 13% of participants) and bleeding (in 17%), while in 7 % had to discontinue the trial due to side effects, so the drug should be studied further.

also the drug only works if Alzheimer’s disease is diagnosed early and not at a more advanced stage. Also, its effect is very small: on a scale of 1 to 18 (from normal to severe dementia), those who took the drug did an average of 0.45 points better. But, according to experts, something is better than nothing. As the trial lasted 18 months, it remains questionable what impact there will be after that time.

The official results of the multicenter, double-blind, randomized phase 3 clinical trial were published in the American medical journal “New England Journal of Medicine” and presented at an Alzheimer’s conference in San Francisco, according to the BBC, Reuters and The Times of New York”.

The results come about two months after the two pharmaceutical companies generated international interest when they announced preliminary data that lecanemab reduced cognitive and functional decline by 27% – relative to a placebo – in a late-stage clinical trial in almost 1,800 patients aged 50-90 who were in the initial stage of the disease. Patients had been diagnosed with mild cognitive impairment or mild Alzheimer’s dementia either by brain positron emission tomography (PET) or by cerebrospinal fluid sampling.

They are created like this new hope for patientsalong with this so far incurable neurodegenerative condition and their families, who have repeatedly seen various drugs show great promise in their initial trials, only to be disproved in practice. On the other hand, two deaths from brain bleeding were reported during the trial of the drug (a 65-year-old woman and an 87-year-old woman who were also taking anticoagulant drugs), which initially led to a drop in the shares of the two companies on the stock market. They deny that the deaths were due to their drug, while their shares subsequently rose.

Lecanemab targets the sticky, toxic plaques of the beta-amyloid protein that build up in the brains of Alzheimer’s patients, gradually destroying vital neuron cells and, by extension, their memory and cognitive functions. According to the company Eisai, after 18 months of testing 68% of people who took the drug had cleared of these brain plaques. So far any drugs just allow a better management of the symptoms, but none can change the course of the disease towards worsening.

The US Food and Drug Administration (FDA) will now decide soon (probably in early January 2023) whether to approve lecanemab for wider clinical use. Biogen and Eisai plan to start the approval application process in other countries in 2023, mainly in Europe and Japan. If approved, it will be the second anti-amyloid beta drug to be approved, following the approval of Aduhelm (aducanumab).

And other companies are in the final stages of developing and testing antibodies against plaques, such as Roche’s gantenerumab and Eli Lilly’s donanemab. Worldwide, the number of people with Alzheimer’s – the main form of dementia – is estimated to be at least 55 million today and is expected to reach 139 million by 2050.

See the scientific publication

RES-EMP

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