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Montelukast trial results coming in December
Larrytherunner
Posted: Wednesday, August 10, 2022 4:33 AM
Joined: 2/26/2016
Posts: 278


I have been taking the anti-inflammatory drug montelukast for the past six years, 10 mg twice and later three times a day, and have gotten great results. The extreme mental fatigue that I was experiencing completely went away.

Both Intelgenx Technologies in Canada and Emory University in Atlanta are conducting clinical trials using montelukast to treat early stage Alzheimers. Health Canada is supervising the Canadian trial and the FDA is supervising the Emory trial. Both have stated in their latest postings on Clinicaltrials.gov that their completion dates will be in October and results will be announced in December 2022.

It has been a long wait because of the nearly two years delay due to Covid-19. I believe the results will be positive due to my own experience with this drug.

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

Intelgenx montelukast Alzheimers trial https://clinicaltrials.gov/ct2/show/NCT03402503

www.montelukast-repurposed.org

 

 


Larrytherunner
Posted: Tuesday, August 30, 2022 11:45 AM
Joined: 2/26/2016
Posts: 278


The Emory FDA montelukast Alzheimers trial started with 150 participants in 2019, half to be treated and half on placebos.The treated participants would take up to 20 mg twice a day for 12 months. When the trial resumed after the the Covid break, Emory cut back the trial from 150 to 32 participants, I believe, due to race between Intelgenx and Emory over who will announce clinical trial results first.

Intelgenx, a Canadian medical technology company, had already started its montelukast Alzheimers trial in 2018 under Health Canada supervision, with a planned 70 participants, half which were to be treated and half to be on placebos for 26 weeks. The approved dosage was 10 mg once a day, the same as the approved dosage for asthma. Intelgenx was having problems funding the trial and the trial was halted just before the Covid break. 

During the Covid break, Intelgenx secured additional funds for its trial and also received authorization from Health Canada to treat participants with up to 30 mg twice a day.

Here is what I think happened next. With the resuming of trials approaching in late 2021, Emory realized that Integenx was now in a position to complete its trial using a more effective dosage and ahead of their own. In order to come out first, Emory reduced its participants to 32. 

As it stands now, Intelgenx under the supervision of Health Canada has 70 participants in a double-blind placebo controlled study with treatments lasting 26 weeks and with dosages up to 30 mg twice a day.

Emory has 32 participants in its FDA double-blind placebo controlled study with treatments lasting 12 months and dosages up to 20 mg twice a day.

So the question is - who will announce results first. Both have announced that they expect to complete their respective trials in October with announcements planned in December.

It would be nice if they were to agree to announce their results on the same day, but so far, that has not been the case.

 


Iris L.
Posted: Tuesday, August 30, 2022 1:12 PM
Joined: 12/15/2011
Posts: 18362


Thanks for sharing, Larry.  I'm looking forward to seeing the results.

Iris


Larrytherunner
Posted: Sunday, September 11, 2022 9:29 AM
Joined: 2/26/2016
Posts: 278


I have to make a correction on the Intelgenx trial anticipated completion date. It is Oct 2023, not Oct 2022 as I posted before. The Emory completion date is still in Oct 2022 with the announcement of results in Nov or Dec 2022.

The Emory trial is small with only 32 participants, but it will be FDA supervised and comprehensive. It is too small to submit to the FDA for approval as a treatment for Alzheimers. However since montelukast has been available for over twenty years as a treatment for asthma, physicians can still prescribe it off label as a treatment for Alzheimers. If the trial shows positive results, many physicians will do that and we will be hearing more about this drug.