Emory QC review
Emory submitted results and is going through QC review
[Nov 2023]. I checked clinicaltrials.gov and found out that Emory University has turned in its montelukast Alzheimers clinical trial results to the FDA on 17 November. FDA rules require clinical trials to report results within one year of its completion. Emory's completion date was 18 November 2022, so they took exactly one year. I wonder why Emory took so long to report results on a trial that had only 32 participants.
Emory montelukast Alzheimer trial
According to the clinical trials site, the Emory results were submitted for quality control review. My concern is that if the results are positive, Biogen's connections within the FDA will lead to more delays in making the results of the montelukast trial public. I certainly hope the QC review will go smoothly without any outside interference.
Is Biogen looking at Emory University's montelukast Alzheimer's clinical trial?
[Dec 2023] Dr Ihab Hajjar, head of the Emory montelukast trial, left Emory soon after the trial ended in Nov 2022 and took a position at the Univ of Texas Southwestern Medical Center, Dallas, TX. At the same time, Biogen was negotiating buying Reata Pharmaceuticals in Plano, TX, a suburb of Dallas. They completed the deal for $7.3 billion in July 2023. Much of Reata's research was done at UT Southwestern.
Do you think that Dr Hajjar's move to a school with Biogen connections is a coincidence? Looks to me like he has become their guy, and Biogen knows the results at Emory were positive and they want to delay, delay, delay. They have already delayed reporting results by one year. Now Biogen may be looking to their FDA connections to reject the results in the QC review and send it back. When will this end.
Emory trial results suggest tampering
[Dec 2023]. The preliminary results on the Emory trial for montelukast were finally posted in December 2023 in clinicaltrials.gov after a year of waiting and the results were sent back to Emory by the FDA quality control for corrections. The results were historic in that it was the first time in a FDA trial that early Alzheimer's and mild cognitive impairment (MCI) participants showed cognitive improvement over a year's time. However there was a problem with the results. The results on the NIH Toolbox Cognition Battery Tests showed that the placebo participants showed significant improvement but the montelukast treated participants declined after one year. Further the placebo group also improved in cerebrospinal fluid (CSF) amyloid and tau measurements. This is a really unexpected result because you just don't see improvement among untreated Alzheimer's patients. CSF amyloid and tau measurements also improved in the placebo group. This shows that there was some tampering going on during the trial.
The trial was double blinded so neither participant nor doctor knew who was getting the real medication. Evidently 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, who was in charge of the trial, took a position right after its completion with the University of Texas Southwestern, which has major connections with Biogen.
Emory montelukast Alzheimer trial
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 8 for CSF Amyloid levels. Scroll to section 9 for CSF Tau levels. Scroll to section 11 for NIH Toolbox Cognition Battery results.
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.
Hopefully the Intelgenx montelukast Alzheimer's trial in Canada, due to be completed in April 2024, will be secure and give positive results.
BioVie FDA trial being investigated for outside tampering
[Dec 2023] BioVie announced on November 29 after the completion of their Alzheimers drug NE3107 oral therapy phase 3 trial that the company discovered violations of good clinical practice at 15 sites, including the copying and pasting of the same information and results from different participants. BioVie notified the FDA Office of Scientific Investigations about the tampering of trial data. BioVie had to exclude 358 out of 439 participants in their trial review. The company's stock dropped 64 percent on the next opening day after the announcement.
This looks like a very organized action with many sites affected. These easily detectable acts were likely meant to be discovered to discredit the trial. The phase 3 trial may have to be done again and it will likely put BioVie years behind in its attempt to get FDA approval. Despite this setback, the remaining participants in the BioVie showed equal to or better results compared to Biogen's FDA approved Alzheimer's drugs lecanemab (Leqembi) and aducanumab (Aduhelm).
Who would be the most likely suspect in sabataging BioVie's trial. In my opinion it would be a big drug maker drug maker involved in researching and marketing Alzheimers drugs.