After 18 months, participants who received lecanemab scored, on average, 0.45 points better on the CDR-SB than those who got a placebo. Some researchers, however, have questioned whether this shift is big enough to make a noticeable difference in a person’s symptoms @meprillaman
It’s a modest benefit, says @BrentForester, director of the Geriatric Psychiatry Research Program @McLeanHospital who helped to run the clinical trial for lecanemab. His concerns lie with safety. About 20% of treated people had brain-scan anomalies
#CTAD22
If a connection between lecanemab and the deaths is found, it could pose “a real conundrum” for the US Food and Drug Administration as it decides how to rule on lecanemab, says Caleb Alexander @JohnsHopkinsSPH and an advisory committee member for the FDA
nature.com/articles/d4158…
@BrentForester is concerned, because, if approved, lecanemab would be given to people who are in the early stages of Alzheimer’s disease and therefore have not experienced much cognitive decline. Complications might therefore worsen their quality of life
“I honestly would be in the camp of not prescribing monoclonal antibodies” to people on anti-coagulation medicines, says @ApostolovaLiana, a neurologist at the Indiana University School of Medicine, who has consulted for @EisaiUS and @biogen @meprillaman
nature.com/articles/d4158…

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More from @BRAINCURES

Dec 5
🧵 What kind of vaccine are you hoping for?

@JeremyFarrar: (laughs) If I knew, I'd be a @NobelPrize candidate–or a multibillionaire...
It would be a once-in-a-lifetime vaccine like the one against measles,
it would cost a cent,
it would block transmission
spiegel.de/international/…
Is it still possible to find a vaccine for this soup of different variants?
@JeremyFarrar: We have to get ourselves out of that situation. And I think the only way we're going to get ourselves out of that is the generation of vaccines
@bredow @VHackenbroch
How realistic is it that a perfect vaccine will materialize?
Farrar: Is it possible today? No, certainly not. Would it be possible this decade? Possibly not yet either.
If the political class moves on & pretend it's over, I fear, that investment won't come
Read 6 tweets
Dec 4
We have tested the antibody in various doses on 856 patients on 3 continents. After only 6 months we observed positive results, and after 18 months 81% of the group receiving the highest dosage showed lower levels of amyloid beta than the level we measure in Alzheimer’s-Lannfelt
“The idea for the antibody originated back in the 1990s, when the team identified a change in the genetic material of a Swedish family that had been severely afflicted by Alzheimer's disease. The mutation indicated that the cause seemed to be protofibrils”
medicalxpress.com/news/2018-10-a…
Overnight a Swedish professor made $350 million. The lucky man, Lars Lannfelt, was not particularly famous. He had done pioneering work on Alzheimer’s, but it was in the 90s and belonged to a sub-field that, after a litany of failures had fallen from grace
statnews.com/2022/10/11/for…
Read 7 tweets
Dec 4
“I hope that Dr. Tessier-Lavigne will not brush off these concerns as irrelevant. There appear to be a lot of visible errors in these papers, and some duplications are suggestive [of] an intention to mislead,” @MicrobiomDigest
@deemostofi @StanfordDaily
stanforddaily.com/2022/11/29/sta…
The @StanfordDaily reached out to Science and @Nature, where another of Tessier-Lavigne’s papers containing alleged data alteration was published, for comment. @ScienceMagazine's editor-in-chief @hholdenthorp wrote in an email that he would “check around.”
Marc Tessier-Lavigne’s papers with issues confirmed by the University have accrued tens of thousands of downloads and include some of his most cited work in neurobiology. None of the papers has been retracted or corrected @tab_delete @StanfordDaily #scipol
Read 8 tweets
Dec 4
Right now, we're going after the pathology of the disease–plaques & tangles-but I think we need to start going after the biology and, as a result, the pharmacology that addresses the altered biology with aging that occurs in Alzheimer's-@a_hfillit @TheADDF
biospace.com/article/ctad-2…
“Lecanemab slows #cognitivedecline. But this is only a start to stopping Alzheimer’s in its tracks. We have a lot of ground to cover to get from the 27% slowing #lecanemab offers to our goal of slowing cognitive decline by 100%"-@a_hfillit on #CTAD22 data
alzdiscovery.org/news-room/anno…
“The mixed data shows that while anti-amyloids are a promising starting point, we will need a combination of drugs aimed at different targets informed by the biology of aging to effectively treat this disease”
-@a_hfillit, M.D., co-founder and CSO @TheADDF
fiercebiotech.com/biotech/roche-…
Read 4 tweets
Dec 3
Today, almost half of the 4 million Americans living with type 1 diabetes use devices called continuous glucose monitors, or CGMs, to monitor their #glucose levels and regulate their insulin levels in real-time.
@statnews' @KatieMPalmer reviews CGM's here:
reports.statnews.com/products/conti…
@statnews unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency use authorizations. It touches on how we got here, where the agency is headed next, and what's at stake
reports.statnews.com/products/speed…
The potential of the psychedelics industry has never been bigger. Long-stigmatized drugs like esketemine, MDMA and psilocybin are advancing rapidly through clinical trials for treatments of a range of mental health conditions @OliviaGoldhill @statnews
reports.statnews.com/products/the-s…
Read 5 tweets
Dec 3
🧵Since the first β-lactam, aminoglycoside, macrolide, tetracycline, and fluoroquinolone classes of antibiotics were discovered and approved from 1940 to 1980, few #antibiotics with novel mechanisms of action have been developed
@thomasmd @akesselheim #AMR
science.org/doi/10.1126/sc…
Phase III clinical trials of a antibiotic in a single disease indication cost about US$70 million. Funding for biotech companies—venture capital or government grants—cannot cover this for a drug that will be sold mainly in short courses
Cooper M & Shlaes D
nature.com/articles/47203…
@BradSpellberg, who studies infectious diseases, sums up the problem: We'll pay $50,000 for a course of cancer chemotherapy that prolongs life by 3 months, but we don't want to pay more than $100 for a course of antibiotics that cures the target infection
nature.com/articles/509S4a
Read 7 tweets

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