Montelukast Repurposed

Montelukast Repurposed


Emory University and Intelgenx montelukast-Alzheimers clinical trials

[May 2020] In September 2019, Emory University announced that they were starting a FDA clinical trial for Alzheimers with the inexpensive anti-inflammatory asthma drug montelukast. It was a one year, double-blind placebo-controlled clinical trial for individuals with mild cognitive impairment (MCI) and early Alzheimer disease. Participants would be treated with up to 40 mg per day. Measurements included cognitive testing, cerebral spinal fluid (CSF) tests and neuroimaging.

This trial was being sponsored not by a drug company but rather by Emory itself. Emory was paying out millions of dollars for this trial. It is very rare for a university to pay for a FDA trial, so evidently their researchers had  confidence in a good outcome.

The trial was halted because of the COVID-19 pandenic and restarted in 2021. Originally it started with 150 participants but it was reduced to 32 participants when it was restarted. Reducing the size eliminated the possibility of having it approved by the FDA as a treatment for Alzheimers. However since it has already been approved as a treatment for asthma, it can still be prescribed for Alzheimers off-label.

[Update Feb 24] The Emory trial was completed in November 2022. The preliminary results were posted in December 2023 and were surprising. Check out the posts in the menu for late 2023 and early 2024.

Another montelukast Alzheimers trial, started by the Canadian medical technogy company Intelgenx in 2018, was also has been put on hold by the COVID pandemic. Intelgenx is a small corporation and began the clinical trial with limited funding. The trial was halted during the COVID pandemic. At the beginning of 2022, the Intelgenx trial restarted with twice a day dosing, new funding and 70 participants. The Intelgenx is expected to be completed under the supervision of Health Canada in April 2024 and results will be announced about a month later. Intelgenx will then seek Canadian and FDA approval.

Emory university  trial

Intelgenx montelukast Alzheimers trial

What is Montelukast?

[June 2020] Montelukast is an anti-inflammatory drug in tablet form approved to prevent or decrease the number or severity of asthma attacks, including exercise induced attacks. It is also approved for the treatment of allergic rhinitis, also known as hayfever, which is the inflammation of the nose passages, which occurs when the immune system over reacts to allergens in the air.  

In recent years, still ongoing research has shown that it can be used to safely treat many medical conditions related to aging. Research has been or is being conducted using montelukast as a therapeutic for Alzheimers, Parkinsons disease, Lewy bodies dementia, stroke, viral pneumonia, covid-19, prostate inflammation, and other diseases envolving inflammation and aging.

How does montelukast work?

[June 2020]  When certain immune cells, such as mast cells and microglia, come in contact with foreign bodies, such as bacteria, viruses, and allergens, they emit cysteinyl leukotrienes, which are immune signalling molecules. These molecules can enter surrounding immune cells through the CysLt receptors, and the cells respond by producing cytokines, which leads to inflammation. Montelukast temporarily blocks these receptors and reduces inflammation. Montelukast doesn't block all these receptors, but when taken multiple times a day, it does significantly reduce chronic inflammation, a condition which increases as persons get older. Thus montelukast can be used to treat many medical conditions brought about by chronic inflammation in old age.  August 2020

Why starting a montelukast clinical trial for Alzheimers has taken so long

[June 2020] Montelukast was developed by Merck and has been available for over 20 years. Montelukast has been considered a possible treatment for Alzheimers as early as 2004, when a US patent was filed for montelukast as a treatment for cognitive decline. Here are some reasons why it has taken so long for an Alzheimers clinical trial to begin.

1. FDA clinical trials are very expensive and drug companies need to complete  trials and make a profit before the patent expires. Perhaps Merck didn't consider it a good bet for approval or the time was not enough. Besides, Merck already was working on an amyloid-beta clearing drug for Alzheimers, Verubecestal, which later failed in trials in 2018.

2. After the montelukast patent expired in 2012, it was available as a generic. The big drug companies are not interested in sponsoring a trial for a drug they can't make money off of.

3. Merck chose the very small theraputic dose for asthma of 10 mg once a day for adults and 5 mg once a day for children. I believe the reason they chose this small dosage over more effective multiple daily doses is that children with asthma were a large part of their market, and they were concerned about the chances of any serious side effects showing up. Law suits involving children are extremely expensive.

This small 10 mg dose per day is not enough to effectively treat Alzheimers and other conditions. If Merck had chosen multiple daily dosages for adults, some doctors and patients could have noticed improvements in other conditions, including Alzheimers, and there would have been an demand for clinical trials.

Montelukast - Children and adults are different

[Aug 2020] Montelukast in its more than twenty years of use has proved to be a relatively safe drug for adults. Unfortunately America's 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 (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 significant percentage of children - side effects such as agitation, depression, and suicidal thoughts. In adults, however, it has proved to be relatively safe.

Some children do have some serious mental side effects with this drug and should not be taking it. This may be because children go through what is called synaptic-pruning as their brains rapidly develop, a process in which immune cells in the brain remove neuro synapses that are not being used. Montelukast may slow down the removal of these unused synapses in childhood. However, older adults have long since stopped the synaptic-pruning process. They need to keep the neuro synapses that the process of aging causes them to lose.

Montelukast may slow down the immune cells that attack those neuro synapses in Alzheimers and other dementias due to aging. Hopefully we will find out more when the Emory University trial in Atlanta, Georgia, USA and the Intelgenx Technologies trial in Canada are completed.

Montelukast as a treatment for enlarged prostate (BPH)

[Aug 2020] I have been taking the anti-inflammatory drug montelukast since February 2016 and my enlarged prostate condition completely went away after about a month after starting treatment. I have been completely back to normal for the past 7 years. I take 10 mg three times a day. The approved dosage of one 10 mg a day for asthma doesn't work for enlarged prostate.

Alpha-reductase inhibitors (finasteride and dutasteride) as well as the alpha blockers, such as tamsulosin, are available here. Unfortunately these drugs perform poorly and have a lot of bad side effects and a more effective drug like montelukast is needed.

In high income countries, if these drugs don't work, men can get effective but expensive procedures done which are usually paid for by insurance or by the government. Not so in most low income countries. Most men in low income countries like Ghana have to go without an effective treatment and suffer. They often end up with kidney damage and kidney failure and other conditions that can shorten their lifes. I believe that montelukast can help a high percentage of men who can not get the more expensive treatments.

I have spoken to a number of medical doctors near where I live in Ghana. Most doctors questioned why this hasn't been discovered before and they don't believe it will work. I explained that the approved dosage for asthma is one 10 mg tablet once a day and the minimum effective dosage for enlarged prostate is 10 mg twice a day. About two years ago, I met a urologist who teaches at a nearby Medical school and I finally convinced him to treat some patients. He says it has been effective for most of his treated patients and he is now proposing a clinical trial at his medical school. I am hoping a trial will get started in 2023.

Jan 2024 update. The University of Cape Coast has decided not sponsor the trial, probably because of lack of funding, but a medical research centre in northern Ghana is looking into starting one.

Montelukast for the prevention and treatment of prostate cancer

[Sep 2020] I found some research that was done using human prostate cells that showed that this drug could possibly be effective for the prevention and treatment of prostate cancer. If the montelukast treatment can lower the PSA number, it could indicate that montelukast has a positive effect on prostate cancer prevention and treatment and further clinical studies and trials may be required.  March 2021

montelukast and prostate cancer