CTAD 2022 -- Endgame for AD

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J11
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CTAD 2022 -- Endgame for AD

Post by J11 »

I know I know I have called the last 10 liftoffs for AD and all 10 are still on the ground.
This time it's different ... We have firm top-line readouts over the next month or two.
Something has to happen this time.

CTAD looks like its an especially good scientific meeting as they provide a pdf for all of their abstracts.
We will have very good insight into the deep bench of AD research.
The speaker lineup also suggests that there will be a focus on AD clinical trials especially those related to mabs.

Enormously exciting!

https://www.ctad-alzheimer.com/


https://www.timeanddate.com/countdown/l ... &font=hand
Last edited by J11 on Wed Aug 10, 2022 8:40 pm, edited 2 times in total.
Alexia C
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Re: CTAD 2022 -- Endgame for AD

Post by Alexia C »

J11 wrote: Tue Aug 09, 2022 7:38 pm CTAD looks like its an especially good scientific meeting as they provide a pdf for all of their abstracts.
We will have a very good insight into the deep bench of AD research.
The speaker lineup also suggests that there will be a focus on AD clinical trials especially those related to mabs.
Enormously exciting!
https://www.ctad-alzheimer.com/
https://www.timeanddate.com/countdown/l ... &font=hand
Hi J11,
I will be a new intern in September and I am looking forward for the top-line readouts! So glad you shared with us this information.
Best,
Alexia
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Re: CTAD 2022 -- Endgame for AD

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Alexia C wrote: Wed Aug 10, 2022 1:13 pm I will be a new intern in September and I am looking forward for the top-line readouts! So glad you shared with us this information.
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Alexia
Hi Alexia,

Welcome to our group! Thank you so much for being an intern!!!
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Re: CTAD 2022 -- Endgame for AD

Post by Attabeth »

Alexia C wrote: Wed Aug 10, 2022 1:13 pm
J11 wrote: Tue Aug 09, 2022 7:38 pm CTAD looks like its an especially good scientific meeting as they provide a pdf for all of their abstracts.
We will have a very good insight into the deep bench of AD research.
The speaker lineup also suggests that there will be a focus on AD clinical trials especially those related to mabs.
Enormously exciting!
https://www.ctad-alzheimer.com/
https://www.timeanddate.com/countdown/l ... &font=hand
Hi J11,
I will be a new intern in September and I am looking forward for the top-line readouts! So glad you shared with us this information.
Best,
Alexia
Welcome Alexia,
I hope you enjoy your time as an intern and find this site to be as informative and supportive as I have during my internship. I have enjoyed talking and meeting with new members from all over the world. I'm sure you are a great addition to the new team and I wish you the best.
Be well,
Beth
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Re: CTAD 2022 -- Endgame for AD

Post by J11 »

Alexia, thank you for posting to the thread and gaining a preview of the excitement available for interns on the APOE4 site. This is the most exciting moment in the century long history of AD clinical research. It does not get better than this!

After all of these decades, we are now only days away from the biggest announcement of all time! Tens of millions of those with clinical Alzheimer's dementia could have a no argument go to treatment with undeniable clinical benefit; and hundreds of millions of the worried well will have the comfort of knowing that a treatment will be on the shelf for them when (and if) they need it. For those of us in the AD community this is almost too much.

I have already ordered my 2 cans of cashews and chocolate bars for the big party, though no popping of balloons and no party happened (I did enjoy all of the party treats)! I then ordered 5 cans of cashews and 5 chocolate bars (though no macadamia nuts because they were too expensive) for AAIC, yeah no party no popping of balloons there either, though another trip to landfill for the empty party containers.

This time (again!) I am calling it a launch and the countdown clock is in motion. This rocket is going out of earth orbit! Lecanemab has Priority review; no Adcomm and crickets from the critics corner. It's uncontested! The only person who wants to still argue about Leca is me! Everyone else not so much.

This is super exciting and you have arrived on scene at just the perfect moment (i.e., just before the celebration begins).

Best Wishes, J11
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Re: CTAD 2022 -- Endgame for AD

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Alexia C wrote: Wed Aug 10, 2022 1:13 pm I will be a new intern in September …..
Best,
Alexia
Hi Alexia! Thanks for joining us as a Support Team intern. I look forward to getting to know you on the Forums!
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Re: CTAD 2022 -- Endgame for AD

Post by NF52 »

Alexia C wrote:
J11 wrote: Wed Aug 10, 2022 7:26 pm Alexia, thank you for posting to the thread and gaining a preview of the excitement available for interns on the APOE4 site. This is the most exciting moment in the century long history of AD clinical research. It does not get better than this!...

I have already ordered my 2 cans of cashews and chocolate bars for the big party, though no popping of balloons and no party happened (I did enjoy all of the party treats)! I then ordered 5 cans of cashews and 5 chocolate bars (though no macadamia nuts because they were too expensive) for AAIC, yeah no party no popping of balloons there either, though another trip to landfill for the empty party containers.
....This is super exciting and you have arrived on scene at just the perfect moment (i.e., just before the celebration begins).

Best Wishes, J11
J11,
I have to thank you for both your kind wishes to Alexia, our new intern, and for a LOL moment for me--even though it makes me cough on Day 5 of COVID--my own countdown to a hoped-for celebration of an end to a mild case. The CTAD conference program which you were kind to post does promise lots of excitement, not only for lecanemab but for other innovative trials, ranging from Phase 1 to Phase 3. I hope to be able to attend virtually and post ASAP any great news.

So get some more chocolate and cashews because, while no one option will be one-size-fits-all, a strong clinical benefit would be compelling!
Nancy
4/4 and still an optimist!
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Re: CTAD 2022 -- Endgame for AD

Post by J11 »

Thank you, Nancy for your comment.

I find it quite magical that I can type comments on my computer thread and then all across the world people can break out in laughter. J11 power yeah! It's as if I have my own printing press that can reach everyone in the world for no cost!

Admittedly, I could achieve this purpose more frequently, though I feel compelled to post numerous dry and somewhat technical comments that many would not find overly interesting, yet are hopefully informative. When my readers have just had enough of these technicalities I add in a perfectly timed (according to a complex reinforcement schedule) comedic interlude. Yet, it might be some time before another tasty "cashew" comment is posted by J11.

It does appear that I will need to load up once again for the big event with party accessories for sometime after September 15th. I think I will wait this out awhile because I do not want to eat all the goodies until the big news drops.

Considering the J11 printing press once again: I suppose many totalitarian style governments have done everything in their power to avoid such democratization of ideas and public conversation. There is a certain subversion that naturally occurs when new voices enter the dialogue. Everything is all set up in a particular way and then other people rearranging things.

This has application to the regulatory process that Aducanumab underwent. The entire regulatory discourse for anti-BA mabs became consumed by treating clinically advanced dementia with maximal doses at the boundary of safety and efficacy. I now would reframe this in terms of a pre-clinical, micro-dose with next to no risk while potentially preventing AD over the long-haul. The efficacy marker would be amyloid removal. If clinical approaches are not showing success, then change the regulatory benchmarks. Unfortunately, decades were spent while a clinically tested mab (i.e., Aducanumab as a naturally reverse engineered product) sat on the shelf.
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Re: CTAD 2022 -- Endgame for AD

Post by J11 »

My overall impression is that we are now at the threshold of the unlock of AD. There has been building of excitement with the approval of Aducanumab and now we are approaching the largely unopposed second generation product Lecanemab and other anti-amyloids. I feel that the past disagreements about Aducanumab have brought us to the point now where a firm foundation has been built and continued argument no longer seems relevant. For quite some time I have noticed how I have been able to disengage from the debate and stand back and let the sheer momentum and data evidence of the ever advancing multiple phase 3 mab trials reach the finish line. Those informed
about the clinical potential of mabs have a reasonably good idea of what can be expected in these trials and would not see much value in additional argumentation.

CTAD reinforces this perception for me. I am not sure whether this is newly posted though I have just noticed the detailed program on the website https://www.ctad-alzheimer.com/ This is a very strong line up. Below are the clinical trial reports that stand out. There are many other oral and keynote presentations that are also strong. These presentations could be viewed as the near exact moment in which the tidal wave of AD finally reverses.

4:50 pm Tuesday November 29 Lecanemab Phase 3 Topline Results
(That's a good one. I think last time when we talked about CTAD they had the Aducanumab presentation at 7:00AM.
By 4:50 PM everyone should be fully awake.)

11:30 AM Wednesday November 30 An Update on Interim Data for the First Tau Aggregation Inhibitor – Hydromethylthionine mesylate (HMTM)

4:15 PM Wednesday November 30 Topline Results of Phase III Graduate I & II Confirmatory Trials with Subcutaneous Gantenerumab


One certainly might wonder whether the Nobel prize in medicine might be awarded for AD in 2022.
The prize will be announced at the earliest on Monday 3 October, 2022 at 11:30 CEST. Clarity is expected to have already read out by that time (?, not completely sure of the timeline for the readout). An announced positive topline
for Clarity would make beta-amyloid mabs the most significant population scale medical breakthrough over the last century. The development of a treatment option for Alzheimer's dementia will have profound effects on society. It is only a question of when the Nobel will go to the AD research community, not if.

Clearly some of the CTADers would be on an AD Nobel nomination list. It would add quite a bit of fizz to the CTAD party if one or more of those at CTAD were to claim a win for the 2022 Nobel Prize in medicine.
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Re: CTAD 2022 -- Endgame for AD

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"Clarity AD: Full results from the Phase 3 confirmatory Clarity AD clinical trial of Lecanemab in patients with early AD will be presented in a scientific session on November 29 at 4:50 p.m. PT. Eisai will host a live webcast of presentations in the session and can be viewed live on the investors section of the Eisai Co., Ltd. website."

It appears that the Clarity results at CTAD a week this Tuesday will be open access. Hopefully, they will simultaneously release the slide deck. If they didn't, then actually seeing the slides might be a problem. We might just see a bunch of smudgy wide angle views where the important numbers might be nearly impossible to decipher.

This result is so monumentally important for so many people that going open access is the right call. The topline for Lecanemab and some other recent scientific breakthroughs are simply too important for the reporting of the findings to be made obscure to the public. Lecanemab seems to be set to go to the FDA without the data package that we had for Aducanumab (i.e., the 2 rounds of FDA Briefing Documents) so this might be one of the few opportunities to be able to develop a better level of understanding before approval-- the upcoming peer reviewed article for Clarity will be one other chance.

I had been wondering whether they might give a standing ovation (perhaps even an encore) at CTAD for these results-- given how many decades some have waited for this day such a response would not be unwarranted. While one would not want to prejudice the FDA's decision, it is not easy to see how one could not show such enthusiasm. I am certain that I would be abysmal at the politics involved-- how does one keep a poker face with a royal flush? Would you even need to pretend with such a hand?


https://www.prnewswire.com/news-release ... 83436.html


https://www.eisai.com/ir/library/presen ... index.html
Last edited by J11 on Tue Nov 22, 2022 8:23 am, edited 2 times in total.
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