Emory's trial results submitted to FDA

Larrytherunner

I checked clinicaltrials.gov a few days ago 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 they took so long to report results on a trial that had only 32 participants. I further wonder why Dr Ihab Hajjar MD left immediately after the trial completion and took a position with the University of Texas Southwestern. He is still listed on the trial as the current responsible party.

Emory montelukast Alzheimer trial https://clinicaltrials.gov/ct2/show/NCT03991988

According to the clinical trials site, the Emory results were submitted for quality control review. My concern is that if the results are positive, will Biogen's connections within the FDA lead to more delays in making the results of the montelukast trial public.

I have a question for our FDA expert Crushed. How long can the FDA delay making the results public while it is doing a QC review? What is the next steps after the review?

M1

Doesn't bode well to me that they waited until the last minute to submit Larry.

ButterflyWings

This is interesting, though I have not looked into it at all. I absolutely believe my DH has benefitted as an asthmatic who took Singular/Montelukast for some time, long before Alz diagnosis. Benefitted in some ways, but also not in other ways. Meaning, I think Montelukast (taken for asthma) helped to slow or mask the cognitive issues well into early mid-stages when we "might" have otherwise noted something was off much earlier.

Would it have made a difference ultimately, in where we are today? Maybe not. But the road may have been much less bumpy had we known some of these potential med connections and cognitive effects. For better or worse. I do hope this can be tested widely and that all who may benefit, may access it.

MN Chickadee

Following. I am on it for asthma and as the child of someone who had Alz I am of course interested in these findings.

mrahope

I'm also following this with interest, as my DH is an asthmatic who had used montelukast for years, and is still taking it.

Larrytherunner

I think that for a person with MCI or early stage Alzheimers, taking 10 mg two or three times a day will show some positive results. Seven years ago I started with 10 mg twice a day and my extreme mental fatigue, which may be the same as what some people describe as brain fog, completely went away within one week of starting. I also started sleeping much more soundly. I started taking 10 mg three times a day about 5 years ago. It is a very safe drug for adults although some children taking it for asthma do have neurological problems.

For a person in the later stages of AD, it may be difficult to evaluate improvement without professional help, although I have received feedback that some patients sleep a lot more soundly.

I recently referred several people with love ones with AD who visited my website to a medical doctor who worked with the Emory trial. One lady reported that he said that he would like to prescribe the drug but can not because of contractual obligations. This means two things to me. "He said he would like to prescribe the drug" means that he knows it works. "He said that he can not prescribe the drug because of contractual obligations" means that he is being paid not to prescribe or promote the drug for AD. The Emory trial was completed more than a year ago and I don't see why they would want to restrict a doctor from prescribing a generic drug off label. I suspect that the contractor is one of the drug makers that is marketing the new monoclonal antibodies for Alzheimers.

As for how to get the drug, it is available in most low income countries without a prescription. If you go across the border to Mexico, you may be able to get it at a pharmacy without a prescription, or they could give you the name of a doctor who could give you one. I live overseas in Ghana so I can buy it without a prescription anytime. Good luck.