Emory trial results have been posted

Larrytherunner

After being sent back twice by the FDA for corrections, the Emory Montelukast Alzheimer's clinical trial results have been posted and they are now much easier to find. Just go to the clinical trial site, click Results Posted, go to Outcome Measures, and check out 8) CSF Amyloid 9) CSF Tau and 11) NIH Toolbox.

Emory montelukast Alzheimer trial

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

As I have mentioned before, there is evidence of a switch in the medications in the Emory clinical trial between groups. How else can you explain how a group of participants (so happens to be the placebo group) improved in cognition as well as amyloid-beta and tau, while the montelukast group declined in cognitive tests. An improvement over a years time period has never happened before in any government supervised clinical trial anywhere. Lecanemab and other monoclonal antibody drugs have only shown a slowing of decline.

Since the trial was double blinded, the supplier of the drugs and the principle investigator Dr Hajjar were likely the only parties who knew the identity of the medications given out to the patients.

Dr Hajjar left Emory soon after the trial ended in Nov 2022 and took a position at the University of Texas Southwestern, 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. Most of Reata's research was done at UT Southwestern.Thus UT Southwestern has a big Biogen connection.

I emailed the FDA Office of Scientific Investigations in January. They replied in February that they are considering an investigation into the Emory trial but can't give out any information, and that I would have to inquire through the Freedom of Information Act. I am sure any reply I get that way will take a long time and be heavily redacted. 

The Intelgenx Technologies montelukast Alzheimer's clinical trial is scheduled to be completed by May 30 of this year in Canada. Because of the Emory fiasco, the Intelgenx version of montelukast may be the first Alzheimer's drug to show cognitive improvement. 

My website:

www.montelukast-repurposed.org

midge333

I am not sure one can conclude anything about a one year trial with a total of 32 patients (16 patients in both control and treatment arms). Amyloid and Tau levels in CSF were basically unchanged in both treated and control groups. Likewise the cognition battery results did not change, i.e., were not statistically different.

Larrytherunner

Midge, how can you say that the cognition battery results are not significantly different between the two groups. When you have improvement in cognition in a group over a years time, something that has never happened before, you have to consider it significant even if it is a small group of 16. One group improving and another group declining has got to be significant. That is why the FDA is investigating.

I believe the Intelgenx trial which is scheduled to be completed at the end of May will give us a clearer picture of the benefits of montelukast as a treatment for Alzheimer's.

midge333

NIH Toolbox Cognition Battery (higher number = better)

Montelukast group

baseline 35.2 (2.53)

1 year 33.9 (2.89)

Control group

baseline 35.4 (2.93)

1 year 37.3 (3.41)

The control group increased from 35.4 to 37.3. If you look at the standard error reported (in parentheses), these numbers are not statistically different, so in reality, no change. With 16 patients in each group you would have to demonstrate a massive biological effect to achieve statistical significance. Perhaps you are talking about a different parameter that I missed.

Larrytherunner

Midge, I was trying to point out something unexpected in that some improvement was seen among the placebo group, which suggests to me that some of placebo participants received the montelukast tablets. We don't know how many participants got these unexpected results and we don't have data on individual participants so we can only guess. The FDA has access to all the data and they informed me by email that they are considering investigating. Hopefully an investigation will help clarify the results.

MN Chickadee

Thank you for sharing. I look forward to the Canadian results.