2023 - Upcoming clinical trial for Parkinson's
New clinical trial for Parkinson's disease
A clinical trial to investigate the use of montelukast, an anti-inflammatory asthma drug, for the treatment of Parkinson's disease will be conducted this year by the world famous Karolinska Institute in Sweden through a grant by the Swedish government.
Montelukast will be given in film form, which allows some of the drug to dissolve in the mouth and go directly into the bloodstream, thus increasing the dosage to the brain. Intelgenx Medical Technologies in Canada will supply the montelukast film.
Intelgenx is already sponsoring a Canadian government supervised clinical trial using montelukast film to treat Alzheimers. This trial is expected to be completed in October 2023. Also Emory University completed a small FDA montelukast trial for Alzheimers in November 2022. I am hoping they will announce the results soon.
I believe that leukotriene inhibiting drugs like montelukast will become common in the next 10 years for treating many conditions related to aging and immune system driven inflammation.
An update of the three montelukast clinical trials
Here is an update of the montelukast trials for Alzheimers and Parkinson disease as of 4 May 2023.
The Emory FDA trial was completed in November 2022. My understanding is that the FDA requires them to report their results within one year of completion. The Emory trial started with 150 participants in 2019 but was halted because of the Covid pandemic. When it restarted, Emory reduced the size to 32, which means that only 16 participants were receiving montelukast, which is way too small for getting FDA approval. However, with positive results, some physicians may agree to prescribe the drug off label. I am wondering if Emory could be looking at some of the early participants who were left out of the second group but still continued to take the drug. Just my speculation.
The Intelgenx montelukast Alzheimers clinical trial under the supervision of Health Canada is scheduled to be completed in October 2023.
A clinical trial to investigate the use of montelukast as a treatment for Parkinsons disease will start later the year by the world famous Karolinska Institute in Sweden through a grant by the Swedish government.
These trials have not gotten much press because they are not being promoted by major pharmaceutical companies, but I am sure you will hear a lot more when results come out later this year.
Montelukast as a preventive for heart disease
Since chronic inflammation is a contributing factor in heart disease and montelukast reduces chronic inflammation, one could surmise that montelukast could be used as a preventive for heart attacks and strokes.
Researchers at universities in Italy, Albania, and the US did an observational study on a population of asthma patients in Albania. The study was composed of 800 asthmatic patients. Two groups of 400 were equally matched by age and gender. One group was taking the approved dosage of montelukast of 10 mg once a day. The other group was not taking montelukast. Patients with a previous history of myocardial infraction or ischemic stroke were excluded.
After three years, 37 of the patients who did not take montelukast had a major cardiovascular event. Only 5 taking montelukast had a major cardiovascular event.
These results are significant, especially considering that montelukast is much more effective taken 10 mg twice or more times a day. If these kind of results were for a new drug with a patent, a drug company would be spending millions of dollars on a clinical trial to get approval for a new treatment. Montelukast, however, is a generic. Clinical trials have been proposed using montelukast for the prevention and treatment of heart disease but have never been carried out.
Montelukast as a treatment for osteoporosis
The following research was done through the cooperation of researchers at Hunter College, NY, NY and two South Korean Universities. It shows that montelukast could be a possible effective preventative and treatment for osteoporosis, periodontitis and rheumatoid arthritis.
A osteoclast (OC) is a type of cell that breaks down bone tissue. Cysteinyl leukotrienes (CysLTR1) play a role in osteoclasts formation, and montelukast inhibits CysLTR1 at its receptor on specific types of immune cells. This research shows montelukast inhibits the formation of osteoclasts in cultures of mouse bone marrow.
A clinical trial would be necessary to determine if it would be an effective treatment for bone loss. As more people start taking this drug multiple times a day in the coming years for other diseases caused by aging and chronic inflammation, we will find out.