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Could this be true -Just got in my email

This message is sent to all Alzheimer's Association and Alzheimer's Impact Movement board members, all Alzheimer's Association staff, and volunteers and supporters of AIM and the Alzheimer's Association.

We have an exciting major development about the potential for a new treatment for Alzheimer’s disease, and we wanted to share the positive results with you as quickly as possible. 

Tonight, initial clinical trial results were announced for a drug called lecanamab which was tested in individuals living with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia. Results from the clinical trial found that this treatment significantly reduces clinical decline from the disease. 

These are the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date. These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. 

We will know more at the end of November when the data behind these initial results will be public. We look forward to learning more at that time about participant safety and representation in the trials. It’s also important to manage our own expectations that this treatment is not yet Food and Drug Administration (FDA) approved and is not yet available in doctors’ offices. 

This is a major milestone for Alzheimer’s disease treatments. It is a significant gain for people with the disease and their families and it further positions us to advance our mission in new and exciting ways. 

We have never been more hopeful, and we hope you share our excitement. Even with the success announced today, we must redouble efforts to discover new targets and test new and more effective treatments for Alzheimer’s and all other dementia. 

Thank you for all that you have done, all you are doing, and all you will do to make this a reality.

Joanne

Joanne Pike, DrPH
President

     
 

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Comments

  • M1
    M1 Member Posts: 6,726
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    Article in the Washington Post this morning (can't post a link, may be behind a paywall).  The data were collected over 18 months (so short time frame) but supposedly saw, beginning at six months, 27% improvement compared to placebo.   Didn't go into detail about what they measured.  Much more definitive, reportedly, than Aduhelm.  Works the same way (blockage of amyloid proteins), and the CEO of the drug company stated that this study proves the amyloid hypothesis.  It's administered by IV infusion twice a month, so drug delivery will still be very problematic and very expensive.  Had the same side effects as Aduhelm:  brain swelling and hemorrhage, but said the rates were "within expectations."  The data will be presented in San Francisco in late November, and they are asking for accelerated approval by January 6, followed by full approval later.

    Medicare just announced last night that part B premiums will be lower next year because of "unexpected savings related to Aduhelm."  I bet they're going to regret and reverse that decision.....

  • mrl
    mrl Member Posts: 166
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    I just got it too. Looks sorta promising-we'll see.....

    Michele

  • Ed1937
    Ed1937 Member Posts: 5,084
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    Sooner or later they will find the total fix for this disease. It might be next year, the next generation, or the next century. But it will happen.
  • [Deleted User]
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  • Jo C.
    Jo C. Member Posts: 2,916
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    For me, it is definitely wait and see; too fast to jump on the band wagon.  So; there is 17% occurrences of micro or macro hemmorhages of the brain . . . that means 17 out of 100 patients or 170 out of 1000.

    That does not, at this point in time with the available data, bring me a feeling of reasonable comfort.

    J.

  • Just Bill
    Just Bill Member Posts: 315
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    There is an interesting discussion on alzheimers, drugs and fraud on the Joe Rogan experience with Max Lugavere. Just google Joe Rogan Max Lugavere on youtube.
  • Lane Simonian
    Lane Simonian Member Posts: 348
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    And the anti-amyloid drug hype continues.

    Lecanemab (formerly BAN2401) only works during the early stages of Alzheimer's diseae and only in APOE4 carriers.  As noted above it can cause brain bleeds and brain swelling.

    On the ADCOMS, for example, where the highest dose group declined 30 percent less than placebo, APOE4 carriers declined 63 percent less and noncarriers only 7 percent less.

    https://www.alzforum.org/news/conference-coverage/second-look-ban2401-data-still-positive-despite-snafu

    Nearly the exact same results in terms of cognition are produced by Aduhelm and donanemab.  Lecanemab may be slightly safer in that it primarily targets amyloid oligomers for removal rather than larger-sized plaques.

    The best anti-amyloid drug candidate at this point is Alzheon's ALZ-801 (formerly tramiprosate).  By preventing the aggregation of amyloid monomers into oligomers it avoids the brain abnormalities caused by other anti-amyloid drugs.  And the results are very similar in terms of cognition, too.

    Highest efficacy was observed in APOE4/4 homozygotes receiving 150 mg BID of tramiprosate, showing statistically significant effects on ADAS-cog and positive trends on CDR-SB (respectively, 40-66% and 25-45% benefit compared to placebo). APOE4 heterozygotes showed intermediate efficacy, and non-carriers showed no benefit.

    https://www.jpreventionalzheimer.com/2003-clinical-benefits-of-tramiprosate-in-alzheimers-disease-are-associated-with-higher-number-of-apoe4-alleles-the-apoe4-gene-dose-effect.html

    APOE4 carriers have higher levels of amyloid in their brain to begin with, so amyloid does secondarily contribute to some of their cognitive dysfunction. 

    Eisai has taken the lead on lecanemab.  So far they are doing better in terms of public relations than Biogen but it is still largely lipstick on a pig. 


  • Jo C.
    Jo C. Member Posts: 2,916
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    Both Aduhelm and this from Biogen and some have been SO fast to jump on that Biogen band wagon despite not being FDA approved and such a small number in the study, rather than waiting for more outcome information of larger numbers before floridly presenting it, and especially not sharing the information re risks while touting the drug leaves me with far less confidence in such sources and unlikely to listen to them.
  • Scooterr
    Scooterr Member Posts: 168
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    I got the e-mail this morning also. Like Jo C said, "lets wait and see." I'm like the rest of you guys hanging on to any glamor of hope. We want it to be right, and there has to be more studies done.
  • [Deleted User]
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  • MN Chickadee
    MN Chickadee Member Posts: 872
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    Honestly I was disappointed to see that in my inbox. I thought the Alzheimers Association would have learned their lesson from the Aduhelm mess but apparently not, they just emailed it from someone other than Harry Johns this time. Instead of giving the impression they are quick to promote drugs from these biotech companies that happen to donate lots of money to the AA,  they ought to wait for the research, review, and authorization process to do its due diligence before spreading what could be false hope, or at best something that is not available to many patients either due to the stage/nature of their dementia or cost. 

    I too am so darn anxious for a cure or effective treatment. To think one of these days researchers will finally crack the code just makes me tingle with hope. Just not sure this is it. 

  • Larrytherunner
    Larrytherunner Member Posts: 83
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    We need to be cautious about this announcement on Lecanemab. After all, this drug has been brought to you by Biogen, the same company that has now abandoned Aduhelm after medicare ruled that they would not pay for it unless it was part of another trial. Here are my reasons for being cautious.

    1. The differences between the treated group and the placebo group were small. The treated group continued to decline but by 27 percent less. 

    2. There was a 17 percent occurrence in small brain bleeds, which doesn't sound insignificant to me.

    3. In the clinical trial, the participants were required to have a diagnosis of Mild Cognitive Impairment due to an intermediate likelihood of Alzheimers disease. In other words, it was not clear if individual participants even have Alzheimers or will get Alzheimers. 

    4. The exclusion criteria of the trial seems very strict. Most MCI patients would not be able to get into this trial because they would be excluded for having pre-existing conditions, so the trial not very representative of the general MCI population.

    5. This drug is given by IV, not a pleasant thing to go through, especially for a sick and elderly person. 

    6. If it is quickly approved, it is going to have a major negative effect on medicare. This drug, along with the required pet scans and expensive lab tests, will costs hundreds of thousands of dollars per patient per year, which would create a huge funding problem for medicare. This would have to be paid for by medicare participants and the taxpayers.

    7. If this drug is approved for MCI patients, Biogen is going to try to get early stage Alzheimers patients into the program - more patients mean more government money for them.

    8. Biogen can not be trusted. Biogen was found to be holding secret meetings with certain FDA board members during the Aduhelm approval process. FDA board members know that a approval of this drug will mean that Biogen will provide them with a brighter financial future.

    9. Once a drug gets full FDA approval, it won't go away even if is found to be ineffective. It seems that the only way that a drug can lose FDA approval is if it is shown to cause serious harm or death. There are plenty of ineffective cancer drugs around that are still being prescribed.

    My hope is that this drug does not get its foot in the medicare door until it is proven effective.

  • zauberflote
    zauberflote Member Posts: 272
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    Victoria, the first thing I did was read it backwards in case it spelled a real word!

    ~~~~

    Is it me or why do I look at the word "Lecanemab" and just itch to solve the REAL  word like it's a scramble?  Nameable? no has a "c"....


Commonly Used Abbreviations


DH = Dear Husband
DW= Dear Wife, Darling Wife
LO = Loved One
ES = Early Stage
EO = Early Onset
FTD = Frontotemporal Dementia
VD = Vascular Dementia
MC = Memory Care
AL = Assisted Living
POA = Power of Attorney
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