2023-09-26 12:00:00
The donanemab study was structured similarly. Just over 1,700 test subjects with early signs of Alzheimer’s took part in it and received either the experimental therapy or a dummy drug every two weeks for 18 months. Across the entire patient group, the CDR-SB score fell by 29 percent less in those treated with the antibody, and by almost 36 percent in a subgroup with low or medium tau deposits in the brain.
Measurable changes with little impact
But what do these values mean for people with dementia? They may notice less of the slowed progression than the numbers suggest. From a scientific perspective, these are “statistically significant,” meaning that they most likely indicate a difference between sham treatment and antibody administration. However, this does not automatically mean that the treatment offers patients significant advantages. Whether it does so is still being actively debated in expert circles. Many critics find the data academically interesting, but consider the clinical benefit to be negligible. Linda Thienpont, for example, judges the effect of donanemab: “It is unclear whether those affected feel it; The disease was only delayed by four to seven months.” The great pressure to finally have an Alzheimer’s drug is leading to even extremely expensive drugs with lots of side effects pushing onto the market. “If you follow the current hype regarding the minimal therapeutic effects, it seems to be less regarding the people than regarding being right,” criticizes Christian Behl.
“If you follow the current hype regarding the minimal therapeutic effects, it seems to be less regarding the people than regarding being right,” Christian Behl, Johannes Gutenberg University in Mainz
Stephan Schilling assesses the situation differently: The almost 30 percent for Lecanemab is just the beginning. He is convinced that the gap between those treated and those who are not treated will increasingly widen as soon as people are treated for longer than 18 months. “The progression of the disease can then possibly be slowed down even more and the need for care can be postponed further.” Christian Behl also confirms that the cognitive impairment is significantly less advanced with the antibodies than without them. However, he points out that things are still going downhill, “just a little slower,” and asks: “Is that really the goal of a convincing therapy?”
The manufacturers of Lecanemab, Biogen (USA) and Eisai (Japan), published the results of the study in a press release before detailed data appeared in the specialist journal “New England Journal of Medicine”. There is an exciting detail hidden in the appendixes to the study: women apparently benefit significantly less from the therapy than men. For the former, the braking effect only accounts for 12 percent, while for the latter it is 43 percent. Since women develop Alzheimer’s disease more often than men – 60 out of 100 affected people are female – this information has great clinical significance. Nevertheless, it was not mentioned in the study report and was hardly communicated otherwise.
Increased risk of swelling and bleeding
Donanemab slowed cognitive decline slightly more than lecanemab, especially in patients with low levels of tau deposits in the brain. But this effect came at a high price: “Side effects such as brain swelling and cerebral hemorrhage were more pronounced. Three people even died,” says Linda Thienpont. Donanemab infusions led to such undesirable effects in around a third of those treated; with lecanemab, they occurred in one in five. However, many of those affected do not even notice if their brain tissue swells slightly or if tiny cerebral hemorrhages occur. Through brain scans that the research teams regularly took of the test subjects as part of the clinical study, the swelling and bleeding might be detected even if they did not cause any symptoms in those affected. However, three to six percent of those treated suffered from headaches, felt nauseous or were confused. Some became unconscious and a few died as a result.
A working group led by neurologist Sherry Chou from the Feinberg School of Medicine at Northwestern University in Chicago reported on the case a 65-year-old patient. The woman came to the emergency room with acute stroke symptoms. The doctors dissolved a blood clot in her head with the usual medication. After almost an hour, the woman’s blood pressure rose dramatically, prompting the medical team to discontinue therapy. A brain scan revealed numerous hemorrhages in her brain. The patient died three days later. She had taken part in the lecanemab study and had already been administered the antibody three times. It had been four days since her last infusion at the time of her stroke.
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