Scientists could barely hold back their excitement following publication of a new clinical drug trial for Alzheimer’s. They described the trial as “a historic moment”, “a new era” and “the beginning of the end”.
The results convinced the FDA to grant the drug accelerated approval. However, some experts are saying “not so fast.” That’s because the treatment is expensive, the benefits are modest, and there’s a dark side to the drug that will no doubt limit its use.
Here’s what you need to know…
After decades of failure, a new drug for early Alzheimer’s is here and it has been shown to not only remove the amyloid protein that forms brain plaques, but also to slow cognitive decline. However, some experts are cautioning that this Alzheimer’s treatment might be as bad—or even worse—than the disease. Let’s start with the clinical science to see just what this drug can do…
Disease Progression Slowed
For the trial, 1,795 patients were enrolled. They were aged between 50 and 90 and diagnosed with early Alzheimer’s (mild cognitive impairment or mild dementia due to Alzheimer’s disease). They also showed evidence of amyloid deposits. They were treated with either the new plaque-busting drug, Lecanemab, which was given by infusion, or placebo.
After 18 months amyloid deposits fell steeply in the drug group compared to a small increase among the placebo group, and disease progression slowed by 27 percent compared to placebo. I’ll admit that all sounds pretty wonderful.
But in real life this represents only a small benefit. The difference in disease progression between the two groups was 0.45 points on the 18-point cognitive scale used (1.21 vs 1.66), a finding described surprisingly by the study scientists as “moderate”. Not in my book!
Two other cognition scales also confirmed the slowdown of disease progression and that the drug fared better when it came to improving patients’ ability to carry out day-to-day activities of living—a big marker of a patient’s ability to remain independent.
In addition, the change between the Lecanemab recipients and those receiving the placebo increased over time, implying that it could have more benefit if the drug is given for longer.
Biogen, who helped develop the drug, described the results as “highly statistically significant”. Their partner, Eisai, said that based on the results it would take those on the drug 25 months to show the same decline as the placebo group showed over 18 months. While they were enthusiastic, I liken this to the minimal benefit some patients with aggressive cancer see with certain drug treatments—another six months of life while enduring terrible side effects. Because, unfortunately, this new drug came with some pretty serious side effects that could in-and-of-themselves damage memory and cognition.
Brain Bleeds And Swelling
The negative reports from the clinical research centered mainly around the drug’s considerable and severe side effects. More than a quarter of drug-treated patients had moderate adverse reactions to the intravenous infusion which was given every two weeks. They mostly experienced nausea, vomiting, fever and flu-like symptoms.
However, upon closer inspection researchers found brain scans revealed bleeding in 17.3 percent of those on the drug versus nine percent of those taking the placebo, while swelling was observed in 12.6 percent of those on Lecanemab but in only 1.7 percent of those on the placebo. And yes, there were deaths from stroke.
The side effects caused 6.9 percent of participants in the Lecanemab group to discontinue the trial compared with 2.9 percent in the placebo group.
More bad news comes with the sizable cost of the treatment. The drug itself costs $26,500 per year plus a clinician is needed to administer the regular infusions. Safety monitoring would involve frequent brain scans.
Accessing specialist diagnostic tests to monitor safety will limit uptake. One dementia expert in the United Kingdom explained, saying, “I am unsure what this will mean in the U.S., as insurers and individuals try to work out if the small clinical benefit is worth the risks and costs.”
Experts Are Cautious
Many neurologists and dementia experts were asked for their opinion on this trial. They all expressed hope this could mark the beginning of effective new treatment options, but they also had serious concerns about the drug. Rob Howard, professor of old age psychiatry at University College London was one of them.
He questioned whether the trial results can be relied upon because a much larger number of patients taking the drug had side effects and dropped out compared to placebo. This may have introduced “unfair bias in favor of the drug.”
Then there’s the modest benefit. There was “[a] 0.45-point advantage…where the accepted minimum worthwhile difference ranges from 0.5 to 1.0 points. This is just too small a difference to be noticed in an individual patient and none of the reported results…reached accepted levels of improvement to constitute a clinically meaningful treatment effect.”
He also questions the drug’s safety, citing three times as many deaths from stroke compared to placebo. He doesn’t think the drug will be taken up widely and he, for one, won’t be advising his patients to take it “because the benefits don’t justify the risks.”
As Professor John Hardy, Group Leader at the UK Dementia Research Institute, explained, and most other experts have repeated, the value of the trial may not lie in the discovery of the drug itself but in what’s expected to develop and evolve from the research. Lecanemab attacks a different form of amyloid than previously tested drugs and it’s hoped the trial’s findings will pave the way for a brighter future.
“This trial is an important first step, and I truly believe it represents the beginning of the end. The amyloid theory has been around for 30 years so this has been a long time coming. It’s fantastic to receive this confirmation that we’ve been on the right track all along, as these results convincingly demonstrate, for the first time, the link between removing amyloid and slowing the progress of Alzheimer’s disease,” says Professor Hardy.
“The first step is the hardest, and we now know exactly what we need to do to develop effective drugs. It’s exciting to think that future work will build on this, and we will soon have life-changing treatments to tackle this disease.”
Even the skeptical Professor Howard believes the study results “show that we are now on a believable path” to better and safer dementia treatments.
However, I won’t be the only one to point out that Professor Hardy’s assertion that the trial pointing to amyloid as the target for treatment is still premature. Scientists are looking at many other ways of tackling the disease and one or more of these could still prove to be a better option than targeting amyloid protein, which may be produced as a negative response to the disease process or may even be produced to protect the brain from the inflammation involved in the development of Alzheimer’s disease.
Meanwhile, you don’t have to wait for this or any other drug to protect your brain against inflammation, toxins or nutritional deficiencies that can pave the way for memory-robbing plaques to form and Alzheimer’s disease to take hold.
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