6 ms·

Alzheimer’s Drug Sharply Slowed Cognitive Decline

88 points by WhitneyLand 12y ago

bjwbell 12y ago
TL;DR Phase 1 trial with 166 patients shows promise (many promising phase 1 trials don't pan out in phase 2 or 3 trials).
- WhitneyLand 12y ago
  It's got a ways to go for sure, but the exciting thing is this is the first drug ever to make it this far, with statistically significant reduction of plaques and cognitive decline.
  - nhstanley 12y ago
    This isn't the first antibody therapy that tries to reduce plaques (Bapineuzumab, solanezumab, gantenerumab, crenezumab, etc.), but is it the first one to "work" correctly, but still fail? I don't believe so. I think bapineuzumab also showed early promise at reducing plaques, though I don't remember if they did a cognitive analysis that Biogen did here. Don't get me wrong. I think this is the most promising one we've had, if for no other reason than the method used to develop it. They took people who lived into old age without Alzheimer's, and found antibodies from them that targeted Abeta (so they claim). Really cool stuff, if true, and very promising.
omgitstom 12y ago
"The drug, called aducanumab, appears to have met or exceeded Wall Street expectations in terms of how much the highest dose slowed cognitive decline. However, there was a high incidence of a particular side effect that might make it difficult to use the highest dose." There is so much that scares me about this statement.
- randyrand 12y ago
  Personally I think it's promising enough that there is nothing bad about the increased R&D money they'll have due to higher stock price. What do you think?
closetnerd 12y ago
It works on amyloid beta. Curious how this drug compares to magnesium supplements since there's been research showing that magnesium also effects the amount of amyloid beta.
- mrfusion 12y ago
  Affects it good or bad?
  - closetnerd 12y ago
    Good: http://www.ncbi.nlm.nih.gov/pubmed/20413885 http://www.ncbi.nlm.nih.gov/pubmed/20413885 "Our findings suggest that supplementation of magnesium has a therapeutic potential for preventing AD."
bluedevil2k 12y ago
The major side effect was brain swelling and headaches. The company developing it even said the side effects are scary (http://mobile.nytimes.com/2015/03/15/your-money/how-many-mutual-funds-routinely-rout-the-market-zero.html?_r=0&referrer= http://mobile.nytimes.com/2015/03/15/your-money/how-many-mut...). These "drug X may help Y" are always misleading, usually by the media. Quote: The most common side-effect was a type of brain swelling. It seemed to pass once a patient's dose was lowered, Biogen said, but it's a worrying symptom, and was worst in patients given the highest dose. Inflammation of the brain has caused companies to dump some earlier experimental Alzheimer's treatments.
- copperx 12y ago
  I read the article you linked and I am baffled.
- cjensen 12y ago
  Your link goes somewhere unrelated to this drug. Copy pasta error?
- stox 12y ago
  Other monoclonal antibody therapies have had similar side effects. There is the possibility that this is a direct reaction to the removal of the plaques. Also, I wouldn't get my hopes up until there is a lot more data. See what happened with Elan's bapineuzumab.
- randyrand 12y ago
  Not sure if linked the right article: http://mobile.nytimes.com/2015/03/15/your-money/how-many-mutual-funds-routinely-rout-the-market-zero.html?_r=0&referrer= http://mobile.nytimes.com/2015/03/15/your-money/how-many-mut... But I want to comment on that. The article makes it seem like mutual fund managers provide no benefit whatsoever because they did not beat the market. Bullshit. They might not help investors make money, but they still provide benefits. Saying otherwise like saying Apple and Google and Microsoft provide no benefit because they have not done any better than the tech sector as a whole. In fact, we can look at the growth of the market as a measure of how well mutual fund managers are investing. We need to remember, mutual fund managers compete with other mutual fund managers. They're investments do matter as they dictate where investment money in our economy goes. They might not make money relative to the market as a whole, but they still provide important benefits to society. For example, just because airlines only make .2% profits, their services benefit society tremendously. Replacing mutual fund managers with investing in any company whatsoever (though limiting to public companies changes things) by "flipping a coin" like the article suggests, would likely have a very bad impact on the economy. It would have no effect on how well mutual fund managers do relative to the market, though.
_ihaque 12y ago
Better scientific overview of this story from In the Pipeline: http://pipeline.corante.com/archives/2015/03/20/biogens_alzheimers_data.php http://pipeline.corante.com/archives/2015/03/20/biogens_alzh...
pcrh 12y ago
This kind of report is aimed at influencing the stockmarket, not at reporting success or failure of a particular therapy. As a Phase I trial, its stated goal is to determine if the treatment is harmful, not if it is beneficial, and to test if the dose range potentially affects whatever they are measuring [1]. Thus, the title of this post is misleading, there was no test to determine the effect of aducanumab on Alzheimer's disease. Biogen's stock will go up nevertheless... apparently it has by over 9% [2]. There is such a large gap between basic understanding of science and biology and those who make markets.... [1]https://en.wikipedia.org/wiki/Phases_of_clinical_research https://en.wikipedia.org/wiki/Phases_of_clinical_research [2] https://uk.finance.yahoo.com/q?s=BIIB https://uk.finance.yahoo.com/q?s=BIIB
- refurb 12y ago
  I see where you're coming from, but I'm going to have to disagree somewhat... This kind of report is aimed at influencing the stockmarket, not at reporting success or failure of a particular therapy. It's both. A company is required/expected to publicly release material information that could influence the stock price. The clinical data also supports whether or not the molecule "passed" this phase of study. there was no test to determine the effect of aducanumab on Alzheimer's disease. There is no reason why you can't have efficacy endpoints in your phase 1 study. The endpoints tested in this study are indicators of progression of Alzheimer's disease. That said (and others here have pointed it out), this is a VERY small study. There have been numerous other examples of Alzheimer's therapy that have show promise in early trials and so far, they have all turned out to be duds. I hope that's not the case here.
  - jonlucc 12y ago
    I'm pretty sure if they add efficacy endpoints to Phase I, it becomes a Phase I/Phase II and the efficacy is for Phase II. The other problem with efficacy in Phase I is that alzheimer's efficacy is not measured over such short time frames.
  - acveilleux 12y ago
    Lack of statistical power. Phase I enrol too few subjects for efficacy. The reason they do a Phase I is to determine it would be safe to do a larger trial. Source: I used to work for the company that is most likely to have done any MRI analysis for this study. We did Phase I/II/III and they are very different beasts.
mrfusion 12y ago
It's odd that people with apoe4 had much higher incidence of the swelling side effect. Why do you suppose that might be?

88 points by WhitneyLand 12y ago

TL;DR Phase 1 trial with 166 patients shows promise (many promising phase 1 trials don't pan out in phase 2 or 3 trials).

WhitneyLand 12y ago
It's got a ways to go for sure, but the exciting thing is this is the first drug ever to make it this far, with statistically significant reduction of plaques and cognitive decline.
- nhstanley 12y ago
  This isn't the first antibody therapy that tries to reduce plaques (Bapineuzumab, solanezumab, gantenerumab, crenezumab, etc.), but is it the first one to "work" correctly, but still fail? I don't believe so. I think bapineuzumab also showed early promise at reducing plaques, though I don't remember if they did a cognitive analysis that Biogen did here. Don't get me wrong. I think this is the most promising one we've had, if for no other reason than the method used to develop it. They took people who lived into old age without Alzheimer's, and found antibodies from them that targeted Abeta (so they claim). Really cool stuff, if true, and very promising.

omgitstom 12y ago

"The drug, called aducanumab, appears to have met or exceeded Wall Street expectations in terms of how much the highest dose slowed cognitive decline. However, there was a high incidence of a particular side effect that might make it difficult to use the highest dose." There is so much that scares me about this statement.

randyrand 12y ago
Personally I think it's promising enough that there is nothing bad about the increased R&D money they'll have due to higher stock price. What do you think?

closetnerd 12y ago

It works on amyloid beta. Curious how this drug compares to magnesium supplements since there's been research showing that magnesium also effects the amount of amyloid beta.

mrfusion 12y ago
Affects it good or bad?
- closetnerd 12y ago
  Good: http://www.ncbi.nlm.nih.gov/pubmed/20413885 http://www.ncbi.nlm.nih.gov/pubmed/20413885 "Our findings suggest that supplementation of magnesium has a therapeutic potential for preventing AD."

bluedevil2k 12y ago

The major side effect was brain swelling and headaches. The company developing it even said the side effects are scary (http://mobile.nytimes.com/2015/03/15/your-money/how-many-mutual-funds-routinely-rout-the-market-zero.html?_r=0&referrer= http://mobile.nytimes.com/2015/03/15/your-money/how-many-mut...). These "drug X may help Y" are always misleading, usually by the media. Quote: The most common side-effect was a type of brain swelling. It seemed to pass once a patient's dose was lowered, Biogen said, but it's a worrying symptom, and was worst in patients given the highest dose. Inflammation of the brain has caused companies to dump some earlier experimental Alzheimer's treatments.

copperx 12y ago
I read the article you linked and I am baffled.
cjensen 12y ago
Your link goes somewhere unrelated to this drug. Copy pasta error?
stox 12y ago
Other monoclonal antibody therapies have had similar side effects. There is the possibility that this is a direct reaction to the removal of the plaques. Also, I wouldn't get my hopes up until there is a lot more data. See what happened with Elan's bapineuzumab.
randyrand 12y ago
Not sure if linked the right article: http://mobile.nytimes.com/2015/03/15/your-money/how-many-mutual-funds-routinely-rout-the-market-zero.html?_r=0&referrer= http://mobile.nytimes.com/2015/03/15/your-money/how-many-mut... But I want to comment on that. The article makes it seem like mutual fund managers provide no benefit whatsoever because they did not beat the market. Bullshit. They might not help investors make money, but they still provide benefits. Saying otherwise like saying Apple and Google and Microsoft provide no benefit because they have not done any better than the tech sector as a whole. In fact, we can look at the growth of the market as a measure of how well mutual fund managers are investing. We need to remember, mutual fund managers compete with other mutual fund managers. They're investments do matter as they dictate where investment money in our economy goes. They might not make money relative to the market as a whole, but they still provide important benefits to society. For example, just because airlines only make .2% profits, their services benefit society tremendously. Replacing mutual fund managers with investing in any company whatsoever (though limiting to public companies changes things) by "flipping a coin" like the article suggests, would likely have a very bad impact on the economy. It would have no effect on how well mutual fund managers do relative to the market, though.

_ihaque 12y ago

Better scientific overview of this story from In the Pipeline: http://pipeline.corante.com/archives/2015/03/20/biogens_alzheimers_data.php http://pipeline.corante.com/archives/2015/03/20/biogens_alzh...

pcrh 12y ago

This kind of report is aimed at influencing the stockmarket, not at reporting success or failure of a particular therapy. As a Phase I trial, its stated goal is to determine if the treatment is harmful, not if it is beneficial, and to test if the dose range potentially affects whatever they are measuring [1]. Thus, the title of this post is misleading, there was no test to determine the effect of aducanumab on Alzheimer's disease. Biogen's stock will go up nevertheless... apparently it has by over 9% [2]. There is such a large gap between basic understanding of science and biology and those who make markets.... [1]https://en.wikipedia.org/wiki/Phases_of_clinical_research https://en.wikipedia.org/wiki/Phases_of_clinical_research [2] https://uk.finance.yahoo.com/q?s=BIIB https://uk.finance.yahoo.com/q?s=BIIB

refurb 12y ago
I see where you're coming from, but I'm going to have to disagree somewhat... This kind of report is aimed at influencing the stockmarket, not at reporting success or failure of a particular therapy. It's both. A company is required/expected to publicly release material information that could influence the stock price. The clinical data also supports whether or not the molecule "passed" this phase of study. there was no test to determine the effect of aducanumab on Alzheimer's disease. There is no reason why you can't have efficacy endpoints in your phase 1 study. The endpoints tested in this study are indicators of progression of Alzheimer's disease. That said (and others here have pointed it out), this is a VERY small study. There have been numerous other examples of Alzheimer's therapy that have show promise in early trials and so far, they have all turned out to be duds. I hope that's not the case here.
- jonlucc 12y ago
  I'm pretty sure if they add efficacy endpoints to Phase I, it becomes a Phase I/Phase II and the efficacy is for Phase II. The other problem with efficacy in Phase I is that alzheimer's efficacy is not measured over such short time frames.
- acveilleux 12y ago
  Lack of statistical power. Phase I enrol too few subjects for efficacy. The reason they do a Phase I is to determine it would be safe to do a larger trial. Source: I used to work for the company that is most likely to have done any MRI analysis for this study. We did Phase I/II/III and they are very different beasts.

mrfusion 12y ago

It's odd that people with apoe4 had much higher incidence of the swelling side effect. Why do you suppose that might be?