AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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J11
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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67 hours 40 minutes!
https://datayze.com/time-until


Couldn't they have waited an hour or two for Eastern time?

Yeah!
They decided to put this up front on Day One!

Why wait? We have already waited enough for effective AD treatment.
A one week teaser pre-announcement is good as an orientation feature to prepare everyone for what is approaching.
Much more would be annoying.

We really need at minimum the topline primaries to be reported.


Set your clocks everyone!!
This is going to be epic.

This is a virtual conference so hopefully there will be some sort of a live feed component to this.

Hmm, I had not been aware that Lucidity was MCI + Mild + Moderate. That is a wide range of illness.
{OK, inclusion was MMSE 16-27 ~ a 3 year window of AD patients https://www.clinicaltrials.gov/ct2/show ... w=2&rank=5}

12:45 PM to 1:45 PM London
Symposium: Phase 3 Interim Data for the First Tau Aggregation Inhibitor – HMTM. Sponsored by TauRx.

Noon Eastern Time is 5 PM London Time.

Roughly 72 hours to go.
Countdown clock please!


" 7:45 AM New York | 12:45 PM to 1:45 PM London | 1:45 PM Paris | 7:45 PM Beijing | 9:45 PM Sydney

Room: Duchy Suite


12-months safety and efficacy data of the Phase 3 LUCIDITY trial, a randomized, double-blind, placebo-controlled, 12-month, safety, and efficacy study of hydromethylthionine mesylate (HMTM) 16 mg/day oral tablet monotherapy in patients with MCI due to probable AD or mild-moderate AD.

LUCIDITY will continue to run for a further 12 months open label phase during which all study patients have access to the 16mg/day oral dose, with expected end results May 2023.

This session will share available information and includes an independent panel discussion on the potential impact of the trial outcome for people with dementia across the spectrum of mild cognitive impairment (MCI) to moderate Alzheimer’s disease, and the future direction of AD research. ... "

https://adiconference.org/programme
J11
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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I am trying to add a clockdown clock with a url. Any help would be appreciated. Appears this feature is not doable from a forum post.
J11
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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Comparisons 1 Edit 10.png[/attachment[attachment=1]LMTX ADAS-cog Dosing Edit 1.png
Comparison 2 Edit 15.png
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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The big presentation is only 2 days away we need to cram hard to know what is going on!

Let's review the taurx results.

The first figure shows the phase 3 with mild AD patients which reported out as positive (after they changed the statistical plan). Recall that the first comparison (comparison A boxed in red) was actually bogus. It compared all those treated with 4 mg bid with 100 mg mono. This really does not make sense because all those treated with 4 mg bid included the 4 mg bid who were on mono- these were the patients that benefited! They compared patients who benefited to other patients that benefited? Wouldn't it be best to compare those who did not receive effective treatment with those who did (i.e., comparisons B & C). They probably included Comparison A because they wanted to use the comparison that was closest to the initial plan. The other comparisons B and C show better comparisons, though the add-ons still probably benefited. The pink vertical bar shows the 4-6 ADAS-cog points that AD patients typically declined. Black horizontal bar is at 5 to show the most likely value.

The first figure shows a benefit at 52 weeks of ~2.6 ADAS-cog 11 (on the right); historical controls would suggest that this should be closer to ~4.1. Mild patients can sometimes show minimal benefit because they might not actually be AD patients. It's not that clear how PET etc. was used to screen patients.

The next figure shows the Mild Moderate Phase 3. Now the benefit has extended out to 5.2 points and the treated patients have actually gained .8 points. Notice how all three arms of mono treated patients 4mg,75 mg and 150 mg showed similar gains. The pink vertical line and the black horizontal line in the second figure show the expected decline of ~5. If the control was light, then the actual gain might have extended out to the nearly impossible ~5.85 benefit.

All these results for LMTM (hereafter referred to as TM (for ~ thionine mesylate) consistently display very positive treatment effects. All the more so for moderate patients.


I want to repost the U dosing curve above, to restate that the 4 mg bid dose did not fully dose the patients. The black triangles to the left by 4 on the y-axis received 8 mg per day, though had substantially less benefit than did others on the same dose. These were the patients in the phase 3 trials! Quite a few of them did not benefit anywhere near what the theoretical curve suggests. Basically some substantial fraction of patients left ~4 ADAS-cog on the table even when receiving 4 mg bid. The totality of the evidence is suggesting that 0 ADAS-cog is the expected change from baseline for those treated with 8 mg bid in the Lucidity trial. The reason why we saw the -0.8 change in the Milds in the phase 3 might have simply been because we were averaging in these patients who declined by ~4 because they were underdosed. At the higher 8 mg dose presumably nearly all of the patients should be in the effective dosing range.
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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Covariates 1.PNG
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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CDR 1a.PNG
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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The first set of results are opaque to my understanding. I am not quite whether they are saying that APOE e4s benefit more or less from treatment. One would expect that e4s would benefit more as they typically have in previous studies. Though from table 3a at the top e4s are reported to benefit by ~4 points while the total results reported for the Milds is also 4 points. This is confusing to me.
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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The next two posts show much clearer results when patients are partitioned by CDR score. Here more advanced patients derive an enormous amount more benefit. In the first comparison of B between 0.5 and 1.0 to the right hand
side the benefit goes from 2.92 to 6.85 as patients are more impaired. That is truly massive -- massively massive.This is though on admittedly diminutive ns.

The results are also given for Comparison C (results are in reverse order). Here we have 3.3 versus 5.3 benefit. Once again favoring more impaired patients ... and once again massive. Also low ns though.

Lucidity kept changing the trial size and patient inclusion, yet from what I remember moderates were added in somewhere ~ mid-way through.

The number on Thursday could be largish. As noted the additional research that looks more carefully at specific subgroups (especially e4s) could show very large benefits.
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Re: AD cured? taurx reports positive Lucidity results !!!!!!!!!!

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44 hours 0 minutes, o seconds to go!

This is super super exciting!
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