Emory preliminary results are out

Larrytherunner · December 2023

The Emory preliminary data results for posted about a week ago on clinicaltrials.gov and there were some surprising results. The results on the NIH Toolbox Cognition Battery Tests showed that the montelukast treated participants declined after one year but the placebo treated participants showed significant improvement. This is a really unexpected result. I think it shows that there was some tampering done during the trial.

The trial was double blinded so neither participant nor doctor knew who was getting the real medication. It could be that someone switched the montelukast and placebo medications between the two groups. I hope the FDA and Emory will investigate, but I believe that they going to find it more convenient to cover it up. I said earlier that Dr Hajjar took a position right after completion of the trial with the University of Texas Southwestern, which has connections with Biogen.

Emory montelukast Alzheimer trial

https://clinicaltrials.gov/ct2/show/NCT03991988

To find preliminary results

1) Scroll down and hit "Results Submitted tab".

2) Scroll down to Blue table and hit "Submission with QC comments".

3) Scroll to section 11.

The NIH Toolbox Cognition Battery shows the treated group went from 35.4 to 33.0, which indicates a decline. The placebo group went from 35.4 to 37.3 and showed improvement, not something you would expect to see. There were no serious adverse events in either group.

There is another montelukast Alzheimers clinical trial going on in Canada which is sponsored by Integenx Technologies. It is being supervised by Health Canada, a part of the Canadian government and is due to be completed in April 2024. Hopefully it will be more secure than Emory.

More bad things are happening to Alzheimers clinical trials. BioVie, a biomedical technology company, announced in late November after the completion of their Alzheimers drug NE3107 oral therapy phase 3 trial that their researchers discovered violations of good clinical practices at 15 of its sites. The head of the company notified the FDA Office of Scientific Investigations for further actions. Out of 439 participants, only 81 remained in the trial, not enough for FDA approval. This likely means that the trial will have to be redone which will put them years behind in seeking approval.

This tampering was evidently highly coordinated and carried on at many different sites. This drug was showing promise of outperforming lecanemab. I think you can guess who I think is the main suspect.

https://www.fiercebiotech.com/biotech/biovie-blames-protocol-errors-trial-sites-phase-3-alzheimers-drug-fail-stock-craters