12x thanks for clearing up some misconceptions about the PDD trial data.
Your well detailed post is worth a second read:
So we have two sets of PDD ph2 results. The original PR was announced on Oct 15, 2020 [1] and published in Nov 2020 CTAD [2]. The 2nd PR was announced June 2021[3]. Both PRs and 2020 CTAD presentation can be found below. Here are my takeaways:
1. It's true the original PR did not mention the primary endpoint was met, but it did not state the primary endpoint failed either. Given the PDD ph2 trial ended on Sep 30, 2020 and the company PR within 2 weeks and CTAD in less than 2 months, my guess is the company did not have enough time to get all the TLD out before CTAD. Episodic Memory was picked b/c it's the most correlated to AD.
2. The 2nd PR in 2021 added 6 new cliams in addition to the original 5 -CDR system Continuity of Attention (CoA) (p = 0.029) new -CDR system Power of Attention (PoA) (p = 0.015) new -MDS-UPDRS Part III (p = 0.024) new -MDS-UPDRS Total (p = 0.038) new -significant (p = 0.035) mRNA expression new -ANAVEX®2-73 does not impair sleep and has a positive effect on REM sleep behavior disorder. original -CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) original -Digital Vigilance (p = 0.008) original -CDR system Episodic Memory (p = 0.047) original -Statistically significant dose-dependent (p = 0.003) improvement of Episodic Memory original
3. What's more exciting is that the company added correlation and prediction for the AD trial, which is the converted ADAS-COG improvement of 4.0 (p=0.015) over placebo over 14 weeks on the high dose. (the assumptions here are (a)14 weeks PDD vs 48 weeks AD (b) the PDD patients have similar AD patient MMSE>20)
Dementia-related Scores Previously reported cognitive outcome measures from this study relevant to Alzheimer’s disease presented at CTAD 2020 observed statistically significant improvement of CDR system Episodic Memory of +42.22 between ANAVEX®2-73 high dose and placebo, which was dose-dependent (p = 0.003).[7] CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).[8] The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the high dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX®2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).[9]
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