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SAN DIEGO — Biogen on Thursday presented detailed data making a case for its resurrected Alzheimer’s drug, arguing that its mixed study results can be explained away by differences in whether patients got the highest dose of the medicine.

But the new data deepen sharp questions about the prospects of the drug and are unlikely to convince skeptics who doubt whether the Food and Drug Administration will be willing to approve it. Biogen’s stock was up 1.75% midday on Thursday after its presentation here at the Alzheimer’s research conference known as CTAD.

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  • the highest 10-milligram-per-kilogram dose

    Apparently, nobody noticed that’s an insanely high dose for a chronic therapeutic treatment. And if you consider the price of Humira “fair”, then a aducanumab dose should cost 10-15 times more. And that, not even taking into consideration potential both acute and chronic side effects of such large doses of exogenous antibody injected

  • If such advanced statistical analysis is required to pull out an effect, the effect must be quite small, right? AD is a relapsing-remitting disease so it will show variation even if the drug is a placebo. It should not be enough to show effectiveness at a detectable level — it should be required to be a useful level.

  • Correction: “ Still, the benefit was only statistically significant for the high-dose group”. They didn’t show p value for the higher exposure group analysis so we don’t know if it’s stat sig for the high dose.

  • bottom line, if you are one of those going to profit on it with an FDA approval, the drug is great. While, if you just care about having a useful medical treatment, that’s not it.

  • I am in the early stages of Alzemeimers My Sister is in the late stages of the disease not ahure how much longer she will last Ive not even told anyone in my family and will not tell after Christmas excecept my wife . I have personally seen the terable things that happen. I am 82 and my sister is 89 I believe that my sister was about the same age as i when first diognost, contact me if you feel you can help I do live in central Calif near Fresno and would like to help in anyway to stop this terrible disiese Thanks for Lissening Gene

  • There is no chance that drugs can help Alzheimer’s patients without removing the causes and that includes both emotional as well as chemical stressors. Removing amyloid plaque which is caused by Acrolein in all likely hood would produce more of the same as our body produces same from oxidative stress.. This company and many others are spreading false hope for profit using statistics that are not at all realistic.

  • The elephant in the room that is not being mentioned – this Biogen drug is an anti-amyloid drug which may have a minor impact on APOE-4 carriers’ cognition. This is 10-15% of the people who have Alzheimer’s . For the rest of those who suffer from the disease it has no effect.

    Anavex is testing its drug ANAVEX®2-73 (blarcamesine) in Alzheimer’s, Rett Syndrome, and Parkinson’s dementia. It restores cellular homeostasis in the brain and in the gut. They have positive results in all three based on tests in the MMSE but also hard data from biomarkers that show healing is taking place. The company does not claim it is a cure, it may be more effective in those treated at earlier stages of CNS disease, but patients in current trials feel better and sleep better. I believe it will be the first drug to tackle the cause of CNS disease rather than just masking symptoms.

    This is one of two posters presented at CTAD, there will be a presentation too.
    http://www.anavex.com/wp-content/uploads/2019/12/CTAD2019_ANAVEX2-73_P84_Microbiota_.pdf

  • My husband is 69, about 4 yrs ago he was diagnosed. We are at the max of his meds. I hope this is a door opening for us.

  • I’m skeptical of any drug of late that’s been approved by the FDA. They are like the big pharmaceutical companies, out for the money! Look at what they already did, pulled it because it didn’t work and then miraculously it did and now the companies stock is up 4% and if it’s approved by the FDA it will skyrocket, making the pharmaceutical company that produces it filthy rich off of people’s suffering, but hey isn’t that what they do anyway? Just my humble opinion.

  • Reducing psychological stress can go a long way for Alzheimer’s – as reported in the following article, lowered stress can bring about a reduction of cognitive decline, reduction in perceived stress, increase in quality of life, as well as increases in functional connectivity, percent volume brain change and cerebral blood flow in areas of the cortex.

    Russell-Williams, J., et al. (2018). Mindfulness and meditation: treating cognitive impairment and reducing stress in dementia. Reviews in the neurosciences, 29(7), 791-804.

    But…profit-driven pharma only wants to focus on biomarkers, biomarkers and how to target biomarkers…

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