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posted by martyb on Sunday November 28 2021, @02:10AM   Printer-friendly

An Alzheimer's Nasal Spray Vaccine Is About to Enter Human Trials For The First Time

Alzheimer's treatments seemed like an unlikely prospect mere months ago.

Drug trials tried and failed for 20 years to produce treatments that would stop the progression of the disease, and several large pharmaceutical companies abandoned the mission of developing Alzheimer's treatments altogether.

[...] Now, the field of Alzheimer's treatments may finally be opening up.

Last week, Brigham and Women's Hospital announced it would spearhead the first human trial of a nasal vaccine for Alzheimer's, designed to prevent or slow the disease's progression.

The trial is small – 16 people between ages 60 to 85 with Alzheimer's symptoms will receive two doses of the vaccine one week apart. But it builds on decades of research suggesting that stimulating the immune system can help clear out beta-amyloid plaques in the brain.

[...] The vaccine sprays a drug called Protollin directly into the nasal passage, with the goal of activating immune cells to remove the plaque.

FDA OKs Phase 1 Trial of Nasal Spray Immunotherapy Protollin

Protollin is a new intranasal immunotherapy made of proteins derived from the outer membrane of certain bacteria. It works by stimulating the innate immune system — the part of the immune system that serves as the body's first line of defense — to clear amyloid-beta plaques and tau tangles from the brain.

It worked in mice, so it must be good.

Also at Medical News Today.

Related: Novel Dementia Vaccine on Track for Human Trials Within Two Years


Original Submission

Related Stories

Novel Dementia Vaccine on Track for Human Trials Within Two Years 36 comments

Novel dementia vaccine on track for human trials within two years:

A newly published study has described the successful results in mice of a novel vaccine designed to prevent neurodegeneration associated with Alzheimer's disease. The researchers suggest this "dementia vaccine" is now ready for human trials, and if successful could become the "breakthrough of the next decade."

The new study, led by the Institute for Molecular Medicine and University of California, Irvine, describes the effect of a vaccine designed to generate antibodies that both prevent, and remove, the aggregation of amyloid and tau proteins in the brain. The accumulation of these two proteins is thought to be the primary pathological cause of neurodegeneration associated with Alzheimer's disease.

The research revealed the vaccine led to significant decreases in both tau and amyloid accumulation in the brains of bigenic mice engineered to exhibit aggregations of these toxic proteins. Many prior failed Alzheimer's treatments over the past few years have focused individually on either amyloid or tau protein reductions, but growing evidence suggests a synergistic relationship between the two toxic proteins may be driving neurodegeneration. Hence the hypothesis a combination therapy may be the most effective way to prevent this kind of dementia.

This new treatment combines two vaccines, dubbed AV-1959R and AV-1980R, which are designed to respectively target amyloid and tau protein aggregations. The vaccine is formulated in a novel adjuvant called Advax, developed by a team of Australian researchers to enhance vaccine immunogenicity.

Advax has been developed by Nikolai Petrovsky, a scientist from Australia's Flinders University who told ABC News Australia the new formulation offers the potential to act as both a preventative vaccine against the development of neurodegeneration, and a curative treatment in subjects already suffering from a build-up of these toxic proteins.

[...] The new research was published in the journal Alzheimer's Research & Therapy.


Original Submission

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  • (Score: 0, Interesting) by Anonymous Coward on Sunday November 28 2021, @02:49AM (1 child)

    by Anonymous Coward on Sunday November 28 2021, @02:49AM (#1200139)
    This is as doomed as the drug the FDA approved that had zero proof of efficacy. Using plaque as a proxy for alzheimers has never been shown to work, and this is no better.

    Just another money grab.

    • (Score: 3, Funny) by DannyB on Monday November 29 2021, @06:03PM

      by DannyB (5839) Subscriber Badge on Monday November 29 2021, @06:03PM (#1200617) Journal

      It will work just fine as long as they remember to take it.

      --
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  • (Score: 0, Interesting) by Anonymous Coward on Sunday November 28 2021, @02:54AM (7 children)

    by Anonymous Coward on Sunday November 28 2021, @02:54AM (#1200142)

    The word "vaccine" is abused out the wack. This scheme sounds like some preventative, mediating drug regiment, and only in the sense "possibly" and "marginally".

    • (Score: 1, Funny) by Anonymous Coward on Sunday November 28 2021, @02:56AM

      by Anonymous Coward on Sunday November 28 2021, @02:56AM (#1200144)

      Just take your Alzheimer's booster every 6 months. If you can remember to do so.

    • (Score: 2, Informative) by Anonymous Coward on Sunday November 28 2021, @03:03AM

      by Anonymous Coward on Sunday November 28 2021, @03:03AM (#1200145)

      There are long-time proven vaccines that are having therapeutic effects post-infection. For example the HPV vaccine injected into a HPV-positive person both strengthens the immune response and prevents relapses after treatment. The same is true for the tetanus vaccine, it is given (often together with immuno globulin) even if a person was previously vaccinated (in most countries it's a mandatory childhood vaccination).
      Whether this one is like that, well... we'll have to see the results of the trials.

    • (Score: -1, Flamebait) by Anonymous Coward on Sunday November 28 2021, @03:52AM (2 children)

      by Anonymous Coward on Sunday November 28 2021, @03:52AM (#1200155)

      OP here, what part of my comment is "flamebait?" You think that's some "anti-vaxxer" "fake news"?

      I usually don't care about modding, but this is redonculous - you (the modder) are the anti-science anti-reason loon.

      • (Score: 2) by The Vocal Minority on Sunday November 28 2021, @12:04PM

        by The Vocal Minority (2765) on Sunday November 28 2021, @12:04PM (#1200196) Journal

        Sorry burned all of my mod points on the parakeet's nonsense so can't mod you back up :(

      • (Score: 1, Insightful) by Anonymous Coward on Sunday November 28 2021, @02:08PM

        by Anonymous Coward on Sunday November 28 2021, @02:08PM (#1200214)

        At a guess, the article claims the spray stimulates the immune system.

        Per merriam webster "2: a preparation or immunotherapy that is used to stimulate the body's immune response against noninfectious substances, agents, or diseases"

        While it may not fit the most widely known concept of a vaccine it still qualifies. If you're going to complain about scientific words you should do your homework. Doubly so if you're going to whine about being called out.

    • (Score: 3, Informative) by khallow on Sunday November 28 2021, @03:07PM

      by khallow (3766) Subscriber Badge on Sunday November 28 2021, @03:07PM (#1200225) Journal

      The word "vaccine" is abused out the wack.

      Not really. They're triggering an immune response to these plaques rather than attacking the plaques directly.

    • (Score: 0) by Anonymous Coward on Monday November 29 2021, @08:41AM

      by Anonymous Coward on Monday November 29 2021, @08:41AM (#1200454)

      Well the word "vaccine" has already been destroyed by forces who apparently now control our speech. So now we can call everything "vaccine." In few hours I will have my hunger "vaccine" along side my thirst "vaccine." But now I'm about to take my tiredness "vaccine."

  • (Score: 0, Disagree) by Anonymous Coward on Sunday November 28 2021, @03:23AM (3 children)

    by Anonymous Coward on Sunday November 28 2021, @03:23AM (#1200149)

    Seems like the researchers have memory loss too, since there have been about a million treatments that remove amyloid plaque and none of them have any effect on the actual disease. It's a symptom, not the cause. It's like fighting lung cancer with cough suppressants.

    • (Score: 1) by khallow on Sunday November 28 2021, @03:09PM (2 children)

      by khallow (3766) Subscriber Badge on Sunday November 28 2021, @03:09PM (#1200226) Journal

      It's a symptom, not the cause.

      Maybe. But even if so, treating the symptom may be good enough to give millions of people a much better life. That's good, right?

      • (Score: -1, Offtopic) by Anonymous Coward on Sunday November 28 2021, @04:02PM

        by Anonymous Coward on Sunday November 28 2021, @04:02PM (#1200241)

        Agreed. More like treating an erection with a blowjob. It doesn't cure it but sure helps in the short term.

      • (Score: 2) by hendrikboom on Monday November 29 2021, @07:21PM

        by hendrikboom (1125) Subscriber Badge on Monday November 29 2021, @07:21PM (#1200638) Homepage Journal

        Is there any evidence that clearing amyloid plaques even helps mentation in the short run? I haven't heard of any.

  • (Score: 0, Troll) by krishnoid on Sunday November 28 2021, @03:27AM (2 children)

    by krishnoid (1156) on Sunday November 28 2021, @03:27AM (#1200151)

    The trial is small – 16 people between ages 60 to 85 with Alzheimer's symptoms will receive two doses of the vaccine one week apart. But it builds on decades of research suggesting that stimulating the immune system can help clear out beta-amyloid plaques in the brain.

    Kind of unusual to call mice "people", but if they've made it to 60 to 85, hey, they deserve it. Maybe that's in mouse years though. Hope they at least get a complimentary American Association of Rodent People membership with it.

    • (Score: 3, Informative) by Beryllium Sphere (r) on Sunday November 28 2021, @03:46AM (1 child)

      by Beryllium Sphere (r) (5062) on Sunday November 28 2021, @03:46AM (#1200154)

      The summary did say "first human trial".

      • (Score: 0) by Anonymous Coward on Sunday November 28 2021, @04:04PM

        by Anonymous Coward on Sunday November 28 2021, @04:04PM (#1200243)

        Phase 1 is safety only, to see if there are any major side effects. Nobody is looking at effects at this point - that's phase 2.

  • (Score: 5, Interesting) by HiThere on Sunday November 28 2021, @04:23AM (4 children)

    by HiThere (866) Subscriber Badge on Sunday November 28 2021, @04:23AM (#1200158) Journal

    The mouse model of alzheimer's is a really poor match to the human disease. There's been lots of things that helped mice, but didn't do anything for people. Also, lots of things that cause reduced plaques in people don't have any beneficial effect on the progression of the disease.

    That said, activating the immune system *is* a different approach. It's likely to have much wider systematic effects that just a single drug. So maybe.

    Well, that's what the human tests are about. First you check if it's reasonably safe, then you check if it's effective. Only if it gets past both of those hurdles should you proceed to widespread human trials looking for rare problems. If this gets past the second hurdle most people will be pleasantly surprised, but the thing is that there *aren't* any good treatments. And there's nothing that's really promissing. So people look for the least unlikely. I understand that drug development is usually this way to some extent, but alzheimers is one of the stand out cases. We don't have a decent theory, even, of what the diseas is. We know some symptoms that usually show up. So any successful treatment will be from an unexpected direction. Let's not rule out spraying a vaccine up your nose without at least trying it. That is works in mice isn't a very strong recommendation, but it's better than nothing.

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    • (Score: 2, Informative) by Anonymous Coward on Sunday November 28 2021, @06:31AM (1 child)

      by Anonymous Coward on Sunday November 28 2021, @06:31AM (#1200170)

      The latest miserable failure is not even an year old.
      "Failure of first anti-tau antibody in Alzheimer disease highlights risks of history repeating", 10 December 2020
      https://www.nature.com/articles/d41573-020-00217-7 [nature.com]

      "Alzheimer's research - forgetful as always!"

      • (Score: 0) by Anonymous Coward on Sunday November 28 2021, @03:14PM

        by Anonymous Coward on Sunday November 28 2021, @03:14PM (#1200228)
        seems that when money is involved, correlation IS causation. Despite the total lack of proof that amyloid plaques cause Alzheimers, and the latest hijinks with the FDA head approving a drug that had no demonstrable value and that doctors are refusing to prescribe because of the deadly side effects, history is repeating itself.

        Why not do reseatro find the true cause of Alzheimers? Well, you can get more money quicker with quack medicine. Because until there is proof that plaques cause Alzheimers, it's the same type of science as using leeches to remove the disease humours from the blood of an anaemic. Money money money, always money, it's a rich patent holder's world.

    • (Score: 1, Interesting) by Anonymous Coward on Sunday November 28 2021, @07:38AM

      by Anonymous Coward on Sunday November 28 2021, @07:38AM (#1200181)

      At a minimum, vaccines such as this could end up being a good choice for patients with certain forms of FAD or EOAD since the effects of plaques and tangles are more established there.

    • (Score: 1, Interesting) by Anonymous Coward on Sunday November 28 2021, @04:11PM

      by Anonymous Coward on Sunday November 28 2021, @04:11PM (#1200246)

      Let's hope the NIH and science funding bodies takes a look at who is really doing the work.

      In my uni - and previous one too (in the US) - the people actually doing the work are untrained foreign kids with barely any supervision. The grant winners may look impressive but they are sipping latte and bullshitting at conferences, trying to score another big grant. The real scientists who put it rrrrrreal fucking hard time to learn the field and thus do real work have been squeezed out.

      There is no place for them. It's grant winners (bullshitters) and cheap foreign students, who in the case of China count as another "win" for the bullshitters since China pays for them to come. The great bullshitters get a pay raise, the labor comes for free, do some bullshit who cares?! What's not to like?

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