SIGMA1 ABCLEAR1 was the only one pre-specified that can be included in the re-assement but that one ALSO FAILED ADL PRIMARY ENDPOINT!!! Stop Beating a Dead Horse José!!!!!!!!!
This is a great post Hosai. One of the best ChatGPT outputs I have ever read. Thanks.
I thinking hitting on all the endpoints is important in weighing the value of the GWAS COL data. As ChatGPT summarized, prospective testing should have been done but the post hoc data looks like it has real value.
Here's my Q&A with ChatGTP regarding the scope of Anavex's genomic survey. Please plug in its very specific answer to your previous question and see what the updated reliability number for ABCLEAR3 might be.
Q. "Estimate the number of genes sampled in the Anavex Alzheimer's Phase 2b/3 trial given the limitations that 'AD relevant pre-specified genetic variants' 'related to the mechanism' of blarcamesine were assessed."
A. Good question. I didn’t find any public data that says the Anavex Phase 2b/3 Alzheimer’s trial *assessed a large panel* of AD-relevant genetic variants in that study. Rather, the pre-specified genetic analysis was quite limited:
* In the Phase 2/3 study, the efficacy subgroup analysis was done **based on SIGMAR1**, specifically the rs1800866 variant. ([NeurologyLive][1]) * According to Anavex’s disclosures, they also pre-specified **COMT** variants (rs113895332 / rs61143203) in their trial design. ([arianapharma.com][2]) * In earlier (Phase 2a) work, they performed a broad genomic analysis: per their 2018/2019 data, they sequenced ~33,311 genes. ([arianapharma.com][3])
**Putting these together:**
* For the Phase 2b/3 trial, the *pre-specified* genetic variants define only **2 genes** (SIGMAR1 and COMT). * The “full genomic analysis” that underpinned the biomarker strategy came from their Phase 2a data, where they looked at ~33,000 genes.
So, if by “number of genes sampled” you mean what they **genotyped/analyzed in the trial**, the answer is more like **2 genes in the pre-specified efficacy subgroup analysis** — not a broad genome-wide gene panel.
If instead you meant how many genes were **screened in their earlier genomic biomarker development** (to pick those pre-specified ones), the number is ~33,000.
If you like, I can try to check the clinical trial protocol (or regulatory filings) to see whether they genotyped any other AD-relevant genes beyond those two — do you want me to do that?
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