My Alzheimer's Journey
Part 125 - Cochrane Study
A study was released today by Cochrane that is highly controversial. Social networks are buzzing with many people seemingly reacting to the headline without reading the study.
I carefully read the study and I have the facts.
First, let’s understand Cochrane. Who are they and what do they do? Based in London, Cochran is a global network of health researchers, patients, and caregivers. According to the Cochrane website, this network works together “to produce and promote trusted, high-quality health information that improves health and healthcare worldwide.”
The headline of the study released this morning is:
Anti-amyloid Alzheimer’s drugs show no clinically meaningful effect
Some (many) people reacted by using the headline to trash Lecanemab and Donanemab. It seemed like people had been waiting for a study to confirm their gut feelings or anecdotal experience. One anonymous person posted, “none of the current treatments are of any value.”
While reading the Cochrane study, I discovered a huge flaw in their methodology.
The study objective is to assess the “clinical benefits and harms of amyloid‐beta‐targeting monoclonal antibodies”. Seventeen studies with a total of 20,342 participants were selected. Some of the studies selected include:
aducanumab
bapineuzumab
crenezumab
donanemab
gantenerumab
lecanemab
ponezumab
remternetug
solanezumab
The seventeen studies were analyzed as a group. This is the problem.
aducanemab was discontinued by Biogen as of November 2024
bapineuzumb showed success in lowering biomarkers (amyloid and tau) in Phase 2 trials; but, it failed to show significant clinical benefit in Phase 3 trials and was associated with serious side effects
crenezumab failed to show significant clinical benefit in reducing cognitive decline in Phase 3 trials and a major prevention study
I could keep going, but I think it is clear that grouping the study results of drugs that failed to show benefit in clinical trials with Lecanemab and Donanemab skewed the results of the entire Cochrane study.
This is the published results of the Cochrane study:
After 18 months of treatment, anti‐amyloid monoclonal antibodies:
may make little to no difference to how bad people’s dementia symptoms are (9 studies, 8053 people);
probably make little to no difference in the decline in memory and thinking ability (13 studies, 9895 people) or the ability to manage everyday activities (3 studies, 3478 people);
may result in a small improvement in more complex everyday tasks, such as shopping, managing finances, taking medication, and using transportation (1 study, 1252 people);
probably result in a small increase in the occurrence of brain swelling. For every 1000 people using monoclonal antibodies, 119 developed brain swelling compared with only 12 of 1000 people using placebo (11 studies, 13,595 people);
may result in a small increase in microbleeds in the brain (3 studies, 4308 people);
do not increase other serious unwanted effects as defined by the study authors (9 studies, 11,904 people); and
do not increase deaths from any cause (7 studies, 9733 people).
The lead investigator of this study in Francesco Nonino. He is a neurologist and epidemiologist, director of the Unit of Epidemiology and Statistics at the IRCCS Institute of Neurological Sciences of Bologna, Italy.
There has been swift reaction to the study.
Alzheimer’s Research UK released a statement that said in part:
“Although the review included data from these trials, much of the evidence the review relies on comes from older experimental drugs that were discontinued due to trials that failed to show ‘meaningful benefit’.
“This review is attempting to paint an entire class of drugs with the same brush even though we know different anti-amyloid treatments can act in different ways,” says Dr Susan Kohlhaas, Executive Director of Research and Partnerships at Alzheimer’s Research UK.
Despite the review’s claims, experts say these should not take away from the achievements of the latest Alzheimer’s drugs.
“Lecanemab and donanemab have shown us that slowing Alzheimer’s is possible, representing genuine progress,” says Prof Sir John Hardy, UCL Institute of Neurology and Vice President of Alzheimer’s Research UK. “They are not perfect, but they have opened the door to a new era of treatment.”
“What matters now is that research into treatments is moving rapidly, and the pipeline of potential therapies is more diverse and promising than at any point in my career.”
Richard Oakley, associate director of research and innovation at the Alzheimer’s Society, said: “This review’s conclusions make the picture look bleaker than it really is, as authors combined results for a majority of failed drug trials with a small number of more recent successful trials.”
There has also been heavy media coverage of the study.
The CBS affiliate in Charlottesville, Virginia posted a story about the Cochrane study on their website. The headline is: Much-hyped Alzheimer’s drugs do not help patients, review finds. Near the end of the story they quote Sir John Hardy, “"This is a silly paper which should not have been published,"
The BBC ran a story with this headline: Breakthrough £90,000 Alzheimer’s drugs unlikely to benefit patients, report suggests. The third sentence in the BBC story states, “However, their report has also provoked a vicious backlash from equally esteemed scientists who label it as fundamentally flawed.”
I have not found a reaction from Cochran. Will they issue an apology or an explanation? Time will tell.
The moral of my post is that everyone (media included) should read and understand studies, reports, and articles before reacting to just the headline.
Before I say goodbye today, I want to remind you that tomorrow is END ALZ day.
My Alzheimer’s Journey does not offer paid subscriptions. Instead, we depend on subscriber donations to cover the cost of research and writing. Additionally, all donations support my direct and indirect Alzheimer’s treatment expenses. Thank you.
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