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Montelukast (Singulair) clinical trials update
Larrytherunner
Posted: Sunday, July 5, 2020 11:51 AM
Joined: 2/26/2016
Posts: 224


It appears that the two clinical trials being conducted using montelukast (Singulair) as a treatment for early stage Alzheimers and Mild Cognitive Impairment (MCI) have been put on hold because of Covid-19. The Intelgenx Medical Technology sponsored trial in Canada started in 2018 under the oversight of Health Canada and has been slowly moving forward. The much larger Emory University sponsored trial was started in September 2019 under the oversight of the FDA. I have been unable to get the exact status of each trial, but I read in Alzforum that the vast majority of Alzheimers clinical trials have been put on hold. I can certainly understand this. Alzheimer patients as a group are older and often have diseases that put them at greater risk for the virus. I am hoping they can start back later this year or sometime next year.

 

One trial that is going forward is the FDA trial at McGill University in Canada, using montelukast for the treatment of Covid-19 pneumonia. The trial will be using a dosage of one 10 mg a day, which I believe will not be enough to be effective.

 

I sent an email to the contacts on the trial announcement, saying that two or three 10 mg tablets a day would be far more effective. It would be a shame if they were to fail because they didn't get the dosage right. Further, this treatment is for a short duration, not for a long term treatment as would be the case with asthma, so long term use should not be a concern.

 

I also contacted Dr Tom Braciale at the University of Virginia, who did research with montelukast as a treatment for viral pneumonia. He agreed that 10 mg once a day is too low and would contact the researchers at McGill.

 

Because of the Corvid-19 pandemic, I am sure that McGill could get quick approval from the FDA for daily multiple doses. In both of the montelukast Alzheimers clinical trials, the one in Canada and the one at Emory, they were able to get approval.

 

I think in the future, researchers will find many uses for montelukast due to its property of safely reducing inflammation due to the aging process.

 

"The COvid-19 Symptom MOntelukast Trial - Full Text View - ClinicalTrials.gov" https://clinicaltrials.gov/ct2/show/NCT04389411


BadMoonRising
Posted: Sunday, July 12, 2020 7:07 PM
Joined: 4/22/2017
Posts: 323


Good work, Larry! I'm impressed that you were able to share your concerns with Dr. Braciale. I think I'll try to get my PCP to prescribe montelukast. He wasn't particularly happy that the Memory Clinic/NIA expert enthusiastically endorsed my participation in experimental drug studies...but since montelukast would prohibit me from participating in those studies, perhaps he would agree to write the dang prescription.

I hope all is going well with you. Love your new photo!



Larrytherunner
Posted: Wednesday, July 15, 2020 10:40 AM
Joined: 2/26/2016
Posts: 224


Thanks Bad Moon. I hope your doctor will be receptive to prescribing it. I have been taking it for more than four years with no bad side effects, only good ones, like no more extreme mental fatigue, my getting better sleep, and just feeling better and more upbeat.

Unfortunately the FDA ruled this year that montelukast must come with a black box warning. This was a result of a 12 year lobbying effort from Parents United for Pharmaceutical Safety and Accountability. This group lobbied the FDA to warn the public about its psychiatric side effects in a small percentage of children being treated for asthma - side effects such as agitation, depression, and suicidal thoughts. In adults, however, it has proved to be very safe.

Doctors don't like black boxes so here's hoping your doctor will prescribe it.