Discovering the new uses for the anti-inflammatory drug Montelukast
Emory announces montelukast FDA trial for Alzheimer
In September 2019, Emory University announced that they were starting a FDA clinical trial with the inexpensive anti-inflammatory asthma drug montelukast. It is a one year, double-blind placebo-controlled clinical trial for individuals with mild cognitive impairment (MCI) and early Alzheimer disease. Participants will be treated with up to 40 mg per day. Measurements include cognitive testing, cerebral spinal fluid (CSF) tests and neuroimaging.
This trial is being sponsored not by a drug company but rather by Emory itself. Emory is 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 have confidence in a good outcome.
It appears that the trial has been put on hold because of the covid-19 pandenic and will restart in 2021.
Another montelukast Alzheimers trial, started by the Canadian medical technogy company Intelgenx in 2018, has also has been put on hold.
Emory university trial https://clinicaltrials.gov/ct2/show/NCT03991988
What is Montelukast?
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?
Why starting a montelukast clinical trial for Alzheimers has taken so long
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.
It has been a long road to getting a montelukast Alzheimers clinical trial started. Covid-19 has put both the Emory and the Canadian trial on hold, but I believe we will get results and FDA approval for Alzheimers by 2021.
Montelukast - Children and adults are different
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 in 2021 when the Emory University trial in Atlanta, Georgia, USA and the Intelgenx Technologies trial in Canada resume. Both have been put on hold due to the pandemic.
Montelukast as a treatment for enlarged prostate (BPH)
Montelukast for the prevention and treatment of prostate cancer
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.
montelukast and prostate cancer