Although the data support it having a moderate cognitive benefit for people, scientists are concerned about its safety.
The results were presented at the Alzheimer's Disease conference in San Francisco and also published in the New England Journal of Medicine. These topline findings were announced in a press release by the developers.
Lecanemab may have contributed to the deaths of two people who had participated in the trial, according to media reports. Lecanemab has not been ruled out as a factor in the death of one person and the death of another person.
Rob Howard is a Psychiatrist at University College London who specializes in dementia. If lecanemab is approved by regulatory agencies, he fears that patients and families who are desperate for Alzheimer's treatments will make a decision.
According to the statement, lecanemab therapy is not associated with an increased risk of death.
A connection between lecanemab and deaths could pose a dilemma for the FDA as it decides how to rule on the drug. The FDA is expected to make a decision on the drug in January.
The lecanemab trial data was published in a very short time. Aducanumab, a treatment for Alzheimer's, has been criticized before. Many researchers think amyloid- is a root cause of Alzheimer's and that aducanumab was designed to sweep clumps of it from the brain. Aducanumab was approved by the FDA last year on the basis that it cleared amyloid from people's brains, but without clear evidence of cognitive benefit.
Lecanemab is the first of its kind to slow mental decline. A group of people with early-stage Alzheimer's were given the treatment during the trial. Half of the people got lecanemab, while the other half got a placebo. The Clinical Dementia Rating–Sum of Boxes (CDR-SB) is a metric used by scientists to assess a person's cognitive abilities.
Participants who received lecanemab scored 0.45 points better on the CDR-SB than those who received placebo. The treatment group showed a reduction in amyloid and other disease markers after using other cognitive tests.
Some researchers are unsure if this shift is noticeable in a person. The minimum difference to be clinically important is one point.
The clinical trial for lecanemab was led by the director of the Geriatric Psychiatry Research Program at McLean Hospital. He is concerned with safety. Less than 3% of people who received lecanemab experienced symptoms related to the brain scans that showed swelling or bleeding.
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The safety profile of aducanumab is not as good as this one. The majority of people in the trials had brain swelling. Lecanemab could be given to people who are in the early stages of Alzheimer's. Their quality of life might be affected by unforeseen circumstances.
There were 13 people who took lecanemab who developed brain bleeds, and only 2 people who took the placebo. This is a small part of the treatment group.
There were two deaths reported in the media during the open-label extension of the trial. Both had stroke related problems.
The person who died after a heart attack and four mini-strokes was prescribed a blood thinner. The other person died from a brain bleed after receiving emergency stroke medicine. Scientists think it's possible that lecanemab weakened the brain's blood vessels by removing amyloid. It is possible that the medications could have triggered bleeding.
It is difficult to determine if lecanemab played a role in the deaths because of the tie with other factors. The things are being explored. He said that the rate of brain hemorrhage is low with lecanemab.
According to Liana Apostolova, a neurologist at the Indiana University School of Medicine in Indianapolis who has consulted for Biogen, she would be in the camp of not giving people anti-coagulation medicine.
Alexander doesn't know whether the deaths will affect the FDA's decision on lecanemab. The agency will consider the data from the phase II trial when making a decision on whether or not to grant accelerated approval. If follow-up studies are conducted to confirm a clinical benefit, the approval will be contingent.
There will be recommendations for careful monitoring if lecanemab is approved.
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