Delay in montelukast trials announcement

Larrytherunner

Since Alzconnected dropped the clinical trials discussions board in the new format, I decided to post here. The Emory University montelukast FDA trial for Alzheimers was completed in November of last year, and yet nine months later, there is still no announcement of results. It is hard to believe that they are still analyzing data in a trial that has only 32 participants.

I understand that results are often not announced in pharmaceutical company sponsored trials if the results are not favorable. However the montelukast trial was not sponsored by a drug company but by Emory itself. Emory has done hundreds of FDA trials and I would not expect them to hold back on this one.

Is the FDA envolved in delaying the announcement of results? Does this have anything to do with the approval and roll out of lecanemab and the upcoming approval of donanemab this year. The 2022 Congressional investigation into the FDA's approval of Biogen's Alzheimers drug Aduhelm shows that there are high level officials in the FDA who are ready to break FDA rules and give favorable treatment to certain drug companies. Certainly positive results for montelukast would be bad news for Biogen and others.

Many physicians, including my daughter, are waiting for the results. After the Covid pandemic, the trial was reduced from 150 to 32 participants, so it is too small to count for approval as an Alzheimers treatment. However montelukast is approved for asthma and some doctors will be willing to prescribe it off label in higher dosages for Alzheimers if the trial results are positive. They are waiting.

Ed1937

Thanks, Larry. It sounds like someone is looking for a little more money to head their way. What a world we live in!

harshedbuzz

I wonder if it's related to increased reports of serious mood and mental health side effects. There's been a trend towards discouraging its use for allergic rhinitis suggesting it be reserved for asthma patients.

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis | FDA

HB

Lane Simonian

Thank you for the update, Larrytherunner. I check periodically for trial results for Montelukast, but it is good to know that you are here to keep us posted.

Jgirl57

That’s interesting! I used to take montelukast for idiopathic hives. I will try and follow the study as well

Larrytherunner

Harshedbuzz, the black box warning was a result of a 12 year lobbying effort directed at the FDA from Parents United for Pharmaceutical Safety and Accountability (they have facebook group and a website).This group lobbied the FDA to warn the public about montelukast's psychiatric serious side effects in a percentage of children - side effects such as agitation, depression, and suicidal thoughts. The vast majority of side effects reported to the FDA envolved children.

Mental side effects in children may be due to montelukast's effect on childhood synaptic pruning, which is the process by which immune cells in the brain remove neuro-synapses that are not being used. Montelukast may slow down the removal of these unused synapses. Older adults have long since stopped the synaptic-pruning process. Montelukast may help older adults keep their neuro-synapses that are under attack during the process of aging and chronic inflammation.

Regardless of side effects, doctors and other concerned individuals should be allowed to see the trial results. Side effects will be listed as a part of the clinical trial.

Iris L.

Thank you for keeping us updated, Larry. A positive result for montelukast would be remarkable and well received by patients!

Iris

Larrytherunner

Jgirl57, if you want to know more about montelukast, you can check out my website:

www.montelukast-repurposed.org

Larrytherunner

Thanks Iris. You are one of the few people that have taken me seriously.