Intelgenx announces preliminary report
[July 2024] I have more information on the Intelgenx Medical Technologies montelukast Alzheimer's trial in Canada. A preliminary report shows participants who took the highest dosage of 30 mg twice a day of their version of montelukast showed significant cognitive improvement. A date for the final report has yet to be announced.
Another much larger trial will need to be conducted to determine effectiveness and dosage. That means that it will take at least another two years for approval. Intelgenx also has to come up with more money to pay for a larger trial.
https://alzheimersnewstoday.com/news/montelukast-oral-film-aids-cognition-mild-moderate-alzheimers/
My timeline
[Oct 2024] More than eight years ago, I started taking the anti-inflammatory asthma drug montelukast multiple times a day as a treatment for my extreme mental fatigue. It has worked incredibly well. The following is a timeline of events related my taking montelukast.
1995 - My mother was diagnosed with early stage Alzheimers.
2009 - I retired from the the Dept of Veteran Affairs and moved from Atlanta, GA to the country of Ghana.
2013 - Dr Spencer Rozin, MD, Lawrenceville, GA, conducted a study of 17 Alzheimers patients treated with montelukast and got positive results.
2015 - Early 2015, I began feeling extreme mental fatigue affecting my concentration. I saw a medical doctor in Ghana who ran all kinds of lab tests which came out normal. He eventually said it was possibly early Alzheimer's and recommend I get enough sleep and keep exercising. He did not give me a mental test but I don't think it would show anything. I was mentally exhausted but I did not reach a state of mental decline, as far as I could tell.
2015 - Dr Ludwig Aigner in Austria treated aging animals with montelukast and showed that montelukast reduced the swelling and over-activation of microglia immune cells in their brains and also strengthened the blood-brain barrier. He concluded that montelukast could possibly be used to treat Alzheimers and other age related dementias.
2016 - I discovered Dr Aigner's research on The Guardian news website. I started taking 10 mg once a day, and was feeling better for about half of the day. When I started taking 10 mg twice a day, the extreme mental fatigue was completely gone.
2016 - In February I made my first post on Alzconnected.org, which was about montelukast.
2017 - I started taking 10 mg 3 times a day after finding generic montelukast in Ghana, which costs much less the brand name version I was buying.
2018 - Intelgenx, a small Canadian medical technology company, began a clinical trial for mild to moderate Alzheimers under the supervision of Health Canada, Canada's equivalent of the FDA. It was halted in 2020 due to Covid-19 and funding problems.
2019 - Emory University started a FDA montelukast Alzheimers clinical trial with 150 participants but was halted in early 2020 due to Covid-19.
2020 - In May my mother passed away in Atlanta, GA with late stage Alzheimers. I have been in Ghana for the past 11 years and could not be with her, but I suggested to my sister that they could try montelukast. She said the doctor wouldn't allow it.
2022 - In January Intelgenx started a new montelukast Alzheimers trial with new funding and dosing up to 30 mg twice a day.
2022 - The Emory montelukast Alzheimers FDA trial restarted with a smaller group of 32 participants.
2023 - The Karolinska Institute in Sweden announced in March 2023 that they will conduct a clinical trial using the Intelgenx version of montelukast to treat Parkinson's disease. You may have heard of the Karolinska Institute through its involvement in awarding the Nobel prizes.
2023 - Emory submitted its results to the FDA in November 2023. The preliminary results, posted on clinicaltrials.org, showed that the placebo group improved in cognitive scores and amyloid and tau lab tests, and the montelukast treated group delined in cognitive scores and lab tests. This suggests that there had been tampering taking place in the trial - that is, medications were switched between the two groups.
2024 - In January 2024 I emailed the FDA Office of Scientific Investigation about the results of the Emory trial. In February they replied that they were considering starting an investigation. They informed me that I would have to inquire through the Freedom of Information Act to receive any further information.
2024 - In May 2024 Intelgenx announced that they have completed their trial. Also in May Intelgenx filed for protection under Canadian law while they sought new investors. Their stock sales were also suspended. Evidently they were running out of money.
2024 - In July 2024 Intelgenx made a short announcement that the trial data suggested that participants who received the highest dosage of 30 mg twice a day showed a statistically significant improvement in cognitive skills compared to the placebo group.
Normally when a drug shows signs of success in a trial, there is a rush to invest. However in this case, investors may be hesitant because even if Intelgenx's version of montelukast proves to be effective, there is the question of "Is it more effective than generic montelukast?" My concern is that one of the pharmaceutical giants envolved in Alzheimer's therapies will set up a straw buyer to take control of Intelgenx and kill the trial and medication. We shall see what happens.