
An experimental drug, lecanemab, is being hailed as a breakthrough inAlzheimer's therapyafter a clinical trial confirms that it slows the progression of cognitive decline in patients with early stages of the disease. However, a detailed report of the findings publishedon Tuesdayshowedserious side effects that certain patients that took the drug suffered, the discussion of whichis now at the forefront.
The findings were published in the New England Journal of Medicine and subsequently presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco, on Tuesday.This comes nearly two months after the Japan-basedEisai and American company Biogen, the developers of lecanemab, said it showed huge potential and slowed down cognitive and functional decline by almost 27 per cent over 18 months.
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The drug was tested on nearly 18,000 participants with early-stage Alzheimer's, while Phase 2, which lasted for a year, did not show a significant difference between patients who received alecanemab as opposed to a placebo and it was not until Phase 3 that aslowed-down progression was not noted.
Phase 3 trials were conducted in over 230 locations across North America, Europe and Asia between 2019 to 2021 with participants aged from 50 to 90, who suffered from mild cognitive impairment due to early Alzheimer's. At least half of the patients, chosen at random were given lecanemab while others received a placebo.
Subsequently, atleast 13 per cent of patients reported dangerous brain swelling and others reported bleeding in the brain during the Phase 3 trials. Furthermore, at least five participants suffered macrohemorrhages and 14 per cent suffered from microhemorrhages, both of which were linked to the drug.
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However, the US-based Alzheimer’s Association welcomed the results, in a statement that said, “Treatments that deliver tangible benefits to those living with mild cognitive impairment (MCI) due to Alzheimer’s and early Alzheimer’s dementia are as valuable as treatments that extend the lives of those with other terminal diseases.”
Lecanemab is said to be an antibody therapy which removes beta-amyloid which are clumps of protein building up in the brain. While it has not been determined how much of this build-up leads to Alzheimer’s in patients, it does indicate how the brain changes due to thisand eventually destroys brain cells.
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Notably, over the span of 18 months, 68 per cent of the participants who took the drug had amyloid clearance as well as lower levels of a different protein, tau, that forms toxic tangles inside brain cells, said the Japanese drugmaker. In an interview with Reuters, Ivan Cheung, Eisai's US chairmansaid the two deaths caused by brain haemorrhages “cannot be attributed to lecanemab.”
Referring to the two participants, where a 65-year-old woman was on medication for clearing blood clots after suffering a stroke and an 87-year-old who was on a blood thinner drug called Eliquis. Eisai said that the company had protocols in place for monitoring brain swelling in participants but sees no need for restrictions on which patients might be eligible for the Alzheimer's drug.
(With inputs from agencies)
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