I think this is the NLY01 clinical trial. NLY01 is a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.
Do you know someone (ages 30 to 80) diagnosed with early-stage Parkinson’s disease (PD) who has not yet received medication for PD? They may be eligible to participate in this research study.
If you are in the USA and haven't yet used meds, this could be worth looking into.
This is a "piggy-back tweak " trial. The results from the first weren't all that great so I assume this is an attempt to improve results.
When did the first trial complete? My understanding was that the first phase 2 trial of NLY01 had only begun fairly recently?
(Also, do you have a link to information about the first trial results?)
I think Sharon is referring to the exenatide Phase 2 trial.
Time will tell whether NLY01 (pegylated exenatide) is more than just a "piggy-back tweaked" exenatide.
Wanna make a bet.
Think about what a pegylated form of exenatide really is before losing your inheritance. It is basically an ER form of exenatide.
Is this a NEW idea Jeff? Really new? Well, let's go back to 2011 and review vivo and in vitro claims. We hear about "inflexion-shift". It ( pegylated form of exenatide) supposedly improves glucoregulatory activity (regulating the combination of insulin and glucagen) compared with exenatide. Is the improvement substantial?
Is this a PD CT or a diabetes CT? Tell me. Can we say diabetes and PD are inevitably linked? If so, how so? are both neurological disease conditions?
Diabetics are at risk of ending up with PD, but nobody knows why.
Sharon
During the last significant discussion of exenatide, you confidently expressed a belief that no published data existed re Exenatide and PD *, and then when provided the links to the trials, you explained that you had somehow missed them.
Makes it harder to take you seriously when you are so sure of your beliefs yet also so lacking in information.
Your take on exenatide is also bizarre. The exenatide group IMPROVED their off-med scores after 14 months. If the hypothesis is that E slows or stops progression (even just of motor symptoms) what result would you have considered a success if an improvement in UDPRS (and not just better than the placebo, but an actual absolute improvement) is not? Does PD need to be completely cured for you to be mildly impressed?
Yes, the studies need to go for longer and have more participants, both of which the NLY01 trial is attempting.
*How you could not be aware of the exenatide studies is difficult to comprehend, even if you believe they are misleading and disappointing, they were big news in the PD community.
Chris,
You are referring to this comment by me:
"I believe no published data exists regarding this drug and its efficacy relevant to PD (specifically "early" PD). Might see something of relevance by late 2022 or 2023, but I doubt it."
Put my comment in context will you please. Would you do that? I was referring to this sentence from the original post: "A Korean company have a new formulation which they claim has better bbb penetration." Get the context now?
since my comment:
Phase 2 results on NLY01 for PD in this trial have never been officially published to my knowledge (nor anywhere on an interim basis I can find). Estimated completion is summer 2021. Figure an official publication a year later at best.
Phase 1 results on NLY01 for PD have never been officially published to my knowledge either. But the Phase 1 results in terms of safety and tolerability with untreated(?) PD participants have been discussed in the media without citation.
I did not discuss pre-clinical trials on rats and mice since most humans are not of that species.
As to your comment about Exenatide (non NLY01) results:
"and not just better than the placebo, but an actual absolute improvement) "
If you actually read the study, what the study showed was that after 48 weeks of treatment those who received exenatide were 4 points better off than those on placebo when they were assessed on a 132-point scale that measures aspects of mobility such as tremor, agility and speech.
4 points on a 132 point scale is worth .0303%. Versus a saline/sugar pill.
If you get carried away by that minute improvement versus a saline/sugar pill, be my guest. I can't.
Sharon
My interest in NLY01 was tweaked (great word!) by this AlzForum article a couple of years ago. It doesn't really have much at all to do with diabetes.
Does Taming Killer Astrocytes Spare Neurons in Parkinson’s Disease?
alzforum.org/news/research-...
Some people love rat and mouse studies. I can't figure out why. Each to his own. Perhaps it is related to the SARS-cov-2 "bat" theory where the bats flew 600 miles to Wuhan and bit everybody.
Unfortunately, PD is a condition that can and does have multiple origins, just like cancer. To normalize glucose metabolism maybe one part of the answer. I doubt it is "the" answer.
Sharon
Sharon
I started this thread in the hope that people who might be eligible for the trial may consider participating in it.
Re exenatide, you might not think that pressing pause on the progression of PD motor symptoms for 14 months is at all impressive, but then you don't have PD, so you couldn't be expected to understand what that might mean. That you think we are all sitting here thinking a specific trial is going to be THE one is just strange. We ALL KNOW that in the ballpark of $23B has been spent chasinf a disease modifying treatment with no material result yet. We ALL KNOW we will likely die without one. YOU DONT NEED TO MENTION IT IN EVERY CT THREAD AS WE ALL ALREADY KNOW.
It doesn't make you look smart to conclude that any indivudal CT will likely underwhelme us, because we ALL ALREADY KNOW THIS. And thats not because we are carl erickson fellows or aloe brunswick fellows (whatever they are, i couldnt find any information about either of them), but because even domesticated animals are capable of pattern recognition, and we know that if PD was a simple problem, it wouldnt still be a problem.
I'm not sure why you have to crap all over every single CT even before they occur. It's not 'informative', its depressing and unhelpful.
Maybe you should be the one delivering the answer to PD, given that you apparently know everything.
This might help the discussion, from the Journal of Parkinson’s Disease — content.iospress.com/articl...
This is the best summary I have seen. Thank you!
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