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Georgia physician - high success rate with montelukast(Singulair)
Dr Spencer Rozin MD practices internal medicine in Lawenceville, Georgia. He presented a summary of case studies of 17 patients with various stages of dementia, which he treated with 20 mg montelukast taken 4 times a day. Montelukast (Singulair) is a FDA approved asthma drug, which is now off patent, and has been shown to block certain neuroinflammatory substances from entering brain cells. If you look at the cases in total, 16 out of 17 showed improvement in either memory, or reduced anxiety and agitation, or both. In other words, 94 percent gained some improvement. This confirms to me that as we get older, increased neuroinflammation is a major cause of dementia and montelukast is an effective treatment.
If you want to print, here is the pdf:
Now there is a question of dosage. I have been taking much less, 10 mg twice a day, which has eliminated the extreme mental fatigue I was experiencing, but I believe I am at a very early stage. Perhaps 20 mg three times a day would be good starting points for most patients. Unfortunately we do not have a completed clinical trial to evaluate the dosage, because no company has come up with the money to pay for one, so it is up to pioneering doctors like Dr Rozin and patients to find the right dosage and use the drug off label.
Fortunately this drug has been been shown to be a very safe drug for long term use, both in the FDA trial as an asthma drug, and in its 15 plus years of availability to patients. In the leaflet enclosed in Singulair box, Merck states that "montelukast has been administered at doses up to 200 mg/day to patients for 22 weeks and in short term studies, up to 900 mg/day to patients for approximately one week without clinically important adverse experiences." These are extremely high doses and shows that montelukast is far safer than nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, Celebrex, Advil, Aleve and others. NSAIDS can cause kidney and/or liver damage at high doses over a long period of time. Montelukast shows none of those concerns and is among the safest anti-inflammatory drugs available.
I salute Dr Rozin for his important case studies, and also Dr Horst Zerbe and Dr Ludwig Aigner at the Canadian pharmaceutical company Intelgenx. Drs Zerbe and Aigner are attempting to do a clinical trial but so far, have not gotten the financial backing to pay for it.
I am sure there are many scientists and medical doctors around the world that know about the potential for this drug. I hope others medical doctors like Dr Rozin will make montelukast available to his or her patients, and then hopefully publish the results. Then eventually it will get into mainstream media, and other doctors will find out, and it can become a mainstream off label prescribed drug, thus becoming the first effective drug to treat the cause of dementia due to aging and Alzheimer's, rather than just treating the symptoms.
I'm glad you are being helped.
Twenty cases is not enough on which to make a judgement.
Case studies are not as good as a clinical trial, but I think this study is an indicator that this drug could work. I myself can't see waiting for many years for clinical trials to completed when the drug is available now and has a very good safety record for long term use. Montelukast reduces neuroinflammation, so like other anti-inflammatory drugs, patients will know in very short time, a few days to a week, whether or not it is working by how they feel. After you quit the drug, you will go back to your previous state in a short time.
I am fortunate that I live overseas and can buy it without a prescription. However you will need a prescription in the US. If you live near Dr Rozin, you can see if you can make an appointment. However, that is not an option for most people. Therefore you can print out a copy of Dr Rozin's paper and see what your doctor thinks. Doctors belonging to HMOs and other medical organizations may be restricted in what they can prescribe, so it may be better to go to a doctor with an independent practice. As far as dosage, I would suggest between 30 and 60 mg a day in divided doses (3 times a day). The dosage has to be greater than the dosage for asthma because the drug has to cross the blood brain barrier.
Ditto on appreciation for your diligent postings, Larrytherunner.
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Larry, I just wonder if there's anything that can be purchased without a prescription, over-the-counter, that might act similarly to Singulair/montelukast, even though not prescription strength.
Or might there be a "natural" alternative - i.e., a supplement or food strategy?
Larry, if you think you've pinpointed the reason montelukast helps dementia / memory, maybe you could find us some non-prescription alternatives that would be safe to try?
Sorry, Onward, there is no over-the-counter (OTC) alternative or natural supplement that works in the way montelukast (Singulair) does. Montelukast is a specially designed molecule that temporarily binds to cysteinyl leukotriene receptors on the surface of cells and prevent these inflammatory substances from entering the cells. There is another similar drug, Accolate, which works the same way, but it also requires a prescription.
Merck in 2014 applied to the FDA for OTC status but it was denied mainly because the committee was concerned that individuals could misunderstand the purpose of the drug, which was for preventing asthma attacks, and not a rescue treatment for an attack. For me, it is not a problem because I live in a country where a prescription is not required. But for you, you need one.
Hopefully you have an understanding doctor. Or you can go to another doctor and say you have been taking it for asthma. Maybe someone on this board knows what you can do. Good luck.
... Montelukast is a specially designed molecule that temporarily binds to cysteinyl leukotriene receptors on the surface of cells and prevent these inflammatory substances from entering the cells. There is another similar drug, Accolate, which works the same way, but it also requires a prescription.
I appreciate your explanations, Larry. I'm not good at understanding the science behind this like you are.
It seems that there are at least a few natural substances that are said to suppress leukotrienes, so maybe they have potential to help a little:
ginger boswellia propolis
You may have already seen this, Larrytherunner, but I will post it anyways.
SAINT-LAURENT, QUEBEC--(Marketwired - Nov. 9, 2017) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), today announced that it has submitted a clinical trial application ("CTA") to Health Canada for approval to initiate its Phase 2a proof of concept ("POC") study with Montelukast in mild to moderate Alzheimer's Disease ("AD").
The study, entitled "A randomized Phase IIa, multi-center, double-blind, placebo-controlled study to assess the safety, feasibility, tolerability, and efficacy of a new buccal film of Montelukast in patients with mild to moderate Alzheimer's Disease," is to be conducted at eight study sites, and will measure several safety and efficacy endpoints following daily dosing for 26 weeks.
IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. Currently, Montelukast is marketed as Singulair®, a once daily tablet for the chronic treatment of asthma and seasonal allergic rhinitis. The drug was first approved by the U.S. Food and Drug Administarion in 1997 and has a very good safety profile. IntelGenx' proprietary VersaFilm™ technology offers several potential advantages over the tablet form of Montelukast, including the avoidance and minimization of first-pass-effects, improved API bioavailability, lower dosing and toxicity, easier swallowing and better patience compliance.
At least, we should be able to find out what group of patients this helps.
Thanks Lane. I had not seen it. I usually check the company's website a couple of times a weeks, but have not done so in a few days. I was hoping that the trial had already started because it was reported in May in Alzforum that they were starting a trial soon. The Canadian government does a great job conducting drug trials, but I wish the company could have come up with enough finiancial support to pay for an FDA trial. Once their brand of montelukast was approved by the FDA, it could be imported into the US where the financial rewards would be much greater. Dr Aigner and Dr Zerbe have supported getting this drug into clinical trials when others have said you can't make money supporting an off patent drug.
We don't exactly when the trial will start. If it in January 2018, maybe we will hear something by July. Thanks again for the info.
Thank you for posting this, and for keeping us updated on your own experience with Montelukast (Singular). Very interesting stuff. I put a lot of weight on people's personal experiences with treatments.
I was looking at the Wikipedia site for Singular and they say that in addition to its anti-inflammatory action it inhibits the enzyme Cytochrome P450-2C8. The Cytochrome P450 (CYP) family of enzymes have been implicated in Alzheimer's. I'm just wondering if Singular may have more than one beneficial effect.
"In the brain, they modulate blood-flow regulation, metabolize cholesterol, and participate in neuroinflammatory processes. CYP activity is also implicated in Alzheimer’s disease (AD), particularly in amyloid-β (Aβ) accumulation in CSF."
It seems that CYP emzymes also break down polyunsaturated fatty acids like omega 3 fatty acid (which is anti-inflammatory). So if Singular is inhibiting these emzymes, that may be a good thing. I want to look at the Luekotriene part of Singular more. Thanks again.
Here some more evidence that getting rid of Leukotrienes, or blocking their receptors like Singular does, is beneficial in the brain.
"These results indicate that leukotrienes contribute significantly to secondary brain injury and subsequent cognitive deficits."
These are important points, Serenoa and larrytherunner. Montelukast/Singulair target a particular g protein-coupled receptor (cysteinyl leukotriene receptor) that is involved in asthma, inflammation, and Alzheimer's disease.
There are many other g protein-coupled receptors involved in Alzheimer's disease plus in some cases receptor tyrosine kinases. So maybe the question is does Montelukast do more that inhibit one form of g protein-coupled receptor or does it have an additional mechanism of action (as an antioxidant, for instance). If it does then it may provide an effective treatment for many people during the early stages of Alzheimer's disease.
Baystate, thanks for the information. I had read in November that Intelgenx had reached an agreement with the Canadian government for clinical trials. I think when the results come out that this drug is the first effective treatment for Alzheimer's, the big pharmaceutical company people are going to be shocked that, with all the billions they spent on new drug research searching for a high priced blockbuster, they were beaten by an inexpensive drug that has been available to the public for more than 15 years.
I have been taking this drug now for more than 22 months and have gone from extreme mental fatigue and occasional confusion to feeling completely normal again. I am thankful that there are investors like you that will give many other people a chance to resume leading a normal life. I hope you get a big return on your investment.
Hi. I am glad that someone out there is listening. Montelukast (Singulair) is an anti-infammatory drug which is FDA approved for reducing the number of asthma attacks in asthma patients. The clinical trial for Alzheimer's and dementia should begin soon in Canada.
I have been taking montelukast since February 2016, so next month makes 2 years. The extreme mental fatigue and occasional confusion that I was experiencing disappeared within a week. I haven't had any bad side effects but I do feel a lot better and I sleep much more soundly, and at 70, I am still out jogging 2 miles every morning. I was taking 10 mg twice a day for a year and a half, but now take 20 mg twice a day since I have been able to get the much cheaper generic.
I am an American but live in Ghana, where montelukast is not a prescription drug but is over the counter, so I have no problem getting it. However since I assume you are in the states, you may run into a problem with your doctor, since American doctors in particular are adverse for legal reasons to prescribing a drug that has not been clinically tested for a particular disease, even if it is FDA approved for different disease. Montelukast has been shown to be very safe for long term use in adults, and millions of prescriptions are made for asthma every year. However you might have a problem getting a prescription from your doctor for Alzheimer's. Let me know how it turns out. I sent you an invitation so we can communicate privately if you would prefer. Thanks.