[HN Gopher] A Positive Amyloid Trial, Finally?
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       A Positive Amyloid Trial, Finally?
        
       Author : kens
       Score  : 25 points
       Date   : 2022-09-28 16:45 UTC (1 days ago)
        
 (HTM) web link (www.science.org)
 (TXT) w3m dump (www.science.org)
        
       | pessimizer wrote:
       | Helpful article. The headlines and editorial coverage of this
       | made it look fantastic, except for any of the concrete
       | information in the story I read, which made it look most likely
       | completely worthless.
       | 
       | https://www.theguardian.com/society/2022/sep/28/alzheimers-d...
       | 
       |  _> Success of experimental Alzheimer's drug hailed as 'historic
       | moment': Study shows cognition in early-stage patients on
       | lecanemab declines by 27% less than those on placebo_
       | 
       | Wow, something's happening!
       | 
       |  _> The cognition of Alzheimer's patients given the drug,
       | developed by Eisai and Biogen, declined by 27% less than those on
       | a placebo treatment after 18 months. This is a modest change in
       | clinical outcome but it is the first time any drug has been
       | clearly shown to alter the disease's trajectory._
       | 
       | We've gone from "historic" to "modest" in two paragraphs.
       | 
       |  _> On a 14-point scale used to assess Alzheimer's progression,
       | patients on the drug scored 0.45 higher than those on the placebo
       | treatment, with an Alzheimer's patient being expected to decline
       | by about 1 point a year._
       | 
       | That is very modest. And it's a questionnaire, not memory
       | testing?
       | 
       |  _> Howard said: "The accepted minimum worthwhile difference
       | ranges from 0.5 to 1.0 points, [meaning] that there are going to
       | be some very difficult conversations and decisions in the next
       | weeks and months."_
       | 
       | So it's not even clinically significant? They have a metric that
       | they decided to call the "accepted minimum worthwhile
       | difference," and this is less than that. Doesn't that mean it's
       | not worthwhile? I'm guessing based on the name.
       | 
       | Is this just the first of a series of press releases to start
       | building up public sentiment that can be eventually used to avoid
       | the controversy generated when the FDA approved the last
       | Alzheimer's drug that definitely didn't work?
        
         | mmastrac wrote:
         | I don't necessarily disagree with your premise, but something
         | _can_ be both historic and modest. The first, tiny steps can
         | show that there's something we can do about it and that's
         | historic.
         | 
         | Whether these benefits actually exist... well I'm on the same
         | page as you with skepticism.
        
           | pessimizer wrote:
           | > something _can_ be both historic and modest.
           | 
           | Totally agreed. But can something be both "historic" and not
           | even "minim[ally] worthwhile"?
        
         | ekianjo wrote:
         | If you read Biogen you already know thete is nothing but fluff
         | at this stage.
        
         | adamredwoods wrote:
         | doh! /removed obvious link
        
           | [deleted]
        
         | qqqwerty wrote:
         | It sounds like the question they still need to answer is if
         | this effect continues indefinitely, or if it is a one time
         | effect. Across a 10 year disease progression this could slow it
         | down by 2.5 years. I might make that trade off, at least in the
         | early stages of the disease. Not sure I would want to slow
         | things down in the later stages though. At that point just get
         | it over with.
         | 
         | It is also not clear from the press release what the response
         | distribution looks like. If some people respond really well and
         | others do not (but it averages out to 27%), maybe Alzheimers
         | treatment starts to look a bit more like cancer. Where you try
         | a few things and hope something sticks. My hunch is that is
         | probably where we are headed, but I am not an expert in this
         | stuff.
        
           | pessimizer wrote:
           | > Across a 10 year disease progression this could slow it
           | down by 2.5 years. I might make that trade off, at least in
           | the early stages of the disease. Not sure I would want to
           | slow things down in the later stages though. At that point
           | just get it over with.
           | 
           | Especially since it seems like there might be some pretty
           | brutal side effects.
        
       | SrslyJosh wrote:
       | > As I write, Biogen stock (BIIB) is up about $70/share, a sudden
       | 35% jump that adds billions of dollars to their market
       | captitalization, so there's definitely a lot of optimism out
       | there.
       | 
       | Who cares if it's reproducible? =)
        
         | gizmondo wrote:
         | You can short it if you think it definitely won't reproduce.
         | Otherwise it's not clear why adding billions to the market cap
         | is unwarranted.
        
       | resoluteteeth wrote:
       | I feel like this should probably be assumed to be a
       | methodological problem or a statistical fluke until proven
       | otherwise at this point.
        
         | bilsbie wrote:
         | It's sad we're at this point where we can't trust anything
         | published. We have to think about funding, politics, peer
         | pressure, publication bias.
        
           | [deleted]
        
         | gizmondo wrote:
         | With p=0.00005 it's very unlikely to be a statistical fluke.
        
         | arolihas wrote:
         | Phase 3 trials are highly regulated and basically designed to
         | not be statistical flukes.
        
         | joelthelion wrote:
         | This is not your regular quick scientific paper, though. It's
         | the result of a very large phase three trial, involving
         | hundreds of very qualified people, and a budget of around a
         | billion dollars. It's as serious as it can be. Of course, we
         | should probably wait to see what the outcome of the FDA review
         | will be.
        
           | jcranmer wrote:
           | It's the press release of the initial analysis of a readout
           | of a clinical trial. Mining the results for good news is a
           | distinct possibility.
        
       | keeptrying wrote:
       | A bit too many brain bleeds in the sideffects for my liking. :-/
        
       | llamaLord wrote:
       | Hasn't the entire amyloid theory been coming under a huge amount
       | of scrutiny recently for being almost a mafia-like cabal of
       | somewhat questionable science?
        
         | jcranmer wrote:
         | > Hasn't the entire amyloid theory been coming under a huge
         | amount of scrutiny
         | 
         | Yes.
         | 
         | > recently
         | 
         | I'm using Derek Lowe as my litmus test for how the field
         | reacts, and he's been leaning against it since around 2015-ish.
         | So "recently" might not be all that recent.
         | 
         | > for being almost a mafia-like cabal of somewhat questionable
         | science?
         | 
         | Uh, what?
         | 
         | It recently came out that one of the papers in Alzheimer's
         | research was faked. However, the importance of that faking on
         | the field is actually relatively little: what it purported to
         | establish was a direct causative link between a single amyloid
         | precursor and memory decline--which was already the prevailing
         | theory. As Derek Lowe describes it
         | (https://www.science.org/content/blog-post/faked-beta-
         | amyloid...):
         | 
         | > I could be wrong about this, but from this vantage point the
         | original Lesne paper and its numerous follow-ups have largely
         | just given people in the field something to point at when asked
         | about the evidence for amyloid oligomers directly affecting
         | memory. I'm not sure how many groups tried to replicate the
         | findings, although (as just mentioned) when people did it looks
         | like they indeed couldn't find the _56 oligomer. And judging
         | from the number of faked Westerns, that's probably because it
         | doesn't exist in the first place. But my impression is that a
         | lot of labs that were interested in the general idea of beta-
         | amyloid oligomers just took the earlier papers as validation
         | for that interest, and kept on doing their own research into
         | the area without really jumping directly onto the_ 56 story
         | itself. The bewildering nature of the amyloid-oligomer
         | situation in live cells has given everyone plenty of
         | opportunities for that! The expressions in the literature about
         | the failure to find _56 (as in the Selkoe lab's papers) did not
         | de-validate the general idea for anyone - indeed, Selkoe's lab
         | has been working on amyloid oligomers the whole time and
         | continues to do so. Just not Lesne's oligomer.
         | 
         | In other words, amyloid hypothesis was prevailing before the
         | paper anyways, it would have remained prevailing without the
         | paper, and the paper itself never appears to have directly
         | inspired actual clinical work on any of the failing drugs. It's
         | hard to believe that the field would have abandoned amyloid
         | hypothesis without the failure: there are many other reasons to
         | believe the amyloid hypothesis, and the main reason to not
         | believe it is only because _clearing amyloid hasn't improved
         | Alzheimer's in actual drug candidates*.
        
         | JamesBarney wrote:
         | This is an exaggeration for clicks. We've since discovered that
         | amyloid beta is probably not the cause. At least isn't very
         | casual, or has sophisticated causality by the time we start
         | treating people. It's also true there were people in control of
         | Alzheimer's spending who had blinders on.
         | 
         | But! There was a lot of reasons to think it was amyloid-beta,
         | everyone with Alzheimer's has amyloid beta, early onset
         | Alzheimer's is related to amyloid beta processing, mice that
         | produce lots of amyloid beta or are injected with amyloid beta
         | have Alzheimer's like symptoms.
        
         | ncmncm wrote:
         | Certainly about every paper nowadays is about stuff going on in
         | a breed of mice engineered to produce lots of amyloid plaques.
         | Hardly nobody knows or cares what happens in actual patients.
         | 
         | The best methods we know of to protect real people against
         | dementia are:
         | 
         | 1. Get vaccinations. It doesn't seem to matter so much which
         | ones. But Tdap and flu are seen to do the job.
         | 
         | 2. Eat plenty of cheese.
         | 
         | 3. Get treatment for herpes. I think valacyclovir is the
         | mainstay.
         | 
         | 4. Keep your gums healthy.
         | 
         | There is no rigorous information to indicate why these seem to
         | make a difference. Precious few people are looking. Certainly
         | the people in charge of grants for Alzheimer's research are not
         | awarding them for any such effort.
         | 
         | When the whole house of amyloid cards finally collapses, what
         | will amyloid specialists do with the rest of their careers?
         | Maybe it would be smart to get a jump on that now...
        
           | canadiantim wrote:
           | Where are you getting your information on the methods to
           | protect against dementia? That seems like a very dubious list
           | tbh
        
           | bilsbie wrote:
           | How much of that is the healthy user bias though. Those are
           | all things healthy people generally do.
        
             | macrolime wrote:
             | Healthy people generally eats lots of cheese and
             | valacyclovir?
        
               | jrussino wrote:
               | You don't serve Emmenthaltrex at your cocktail parties?
               | ;-)
        
           | UncleOxidant wrote:
           | Cheese? Where is that coming from?
        
             | mmastrac wrote:
             | Most studies are done on mice... /s
             | 
             | But seriously,
             | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6073537/
             | 
             | > Oleamide and dehydroergosterol identified from Camembert
             | cheese induce microglia into the M2 anti-inflammatory
             | phenotype, leading to neuroprotection. The mechanisms that
             | regulate microglial activation and inflammation in
             | Alzheimer's disease are important targets for disease
             | prevention. The regulation of microglia via daily lifestyle
             | habits has been receiving increasing attention. The intake
             | of neuroprotective and anti-inflammatory compounds
             | including oleamide and dehydroergosterol in meals is safe
             | and easy, so nutritional approaches are promising for the
             | prevention of neurodegenerative disorders.
        
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       (page generated 2022-09-29 23:01 UTC)