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Georgia physician - high success rate with montelukast(Singulair)
Larrytherunner
Posted: Tuesday, April 4, 2017 1:33 PM
Joined: 2/26/2016
Posts: 59


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.

 https://benthamopen.com/FULLTEXT/TONEUJ-11-7

 If you want to print, here is the pdf:

https://benthamopen.com/contents/pdf/TONEUJ/TONEUJ-11-7.pdf

Dr Rozin's website… http://www.drrozin.com/

 

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.

 

 

 


Mimi S.
Posted: Tuesday, April 4, 2017 7:11 PM
Joined: 11/29/2011
Posts: 5961


I'm glad you are being helped.

Twenty cases is not enough on which to make a judgement.


Larrytherunner
Posted: Wednesday, April 5, 2017 1:26 PM
Joined: 2/26/2016
Posts: 59


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.


onward
Posted: Wednesday, April 12, 2017 8:17 PM
Joined: 12/20/2011
Posts: 217


Larry, thanks for this information. It's good of you to take the time and trouble to share it with us. Please continue to update us on any further developments.
Larrytherunner
Posted: Thursday, April 13, 2017 10:50 AM
Joined: 2/26/2016
Posts: 59


Thanks for the encouragement. I check Google about 3 times a week for news, which you can also do. It is surprising that Google can quickly pick up news that has been on the internet for only a few days. Just search "montelukast Alzheimer's" or "montelukast dementia". Being an off patent drug, there is no big pharma company promoting it, so when I see some news, I try to get the word out in my small way.
JazzyOne
Posted: Thursday, April 13, 2017 1:18 PM
Joined: 11/28/2016
Posts: 128


Ditto on appreciation for your diligent postings, Larrytherunner.

For those interested, Google Search has a highly customizable "Alerts" feature where it can be set up to automatically repeat searches and then e-mail results whenever new results for topics are found. Here's the description:

https://support.google.com/websearch/answer/4815696?hl=en&ref_topic=3036132

 


onward
Posted: Thursday, April 13, 2017 9:31 PM
Joined: 12/20/2011
Posts: 217


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?


Larrytherunner
Posted: Friday, April 14, 2017 7:27 AM
Joined: 2/26/2016
Posts: 59


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.

.


Larrytherunner
Posted: Friday, April 14, 2017 7:37 AM
Joined: 2/26/2016
Posts: 59


Thanks Jazzy for your support. I will have to check out your Google search option.
onward
Posted: Friday, April 14, 2017 1:48 PM
Joined: 12/20/2011
Posts: 217


Larrytherunner wrote:

... 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
 
 

 



Larrytherunner
Posted: Friday, April 14, 2017 3:47 PM
Joined: 2/26/2016
Posts: 59


Onward, I am not a fan of natural products. Natural products maybe good for skin care and a few other health areas, but not in the area of dementia and Alzheimer's. I think effective treatments will be found in the area of drug research. Lane is a big supporter of natural products. You can reply to one of his topics and he can give you some advice.
Lane Simonian
Posted: Sunday, November 12, 2017 10:20 PM
Joined: 12/12/2011
Posts: 4038


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.


Larrytherunner
Posted: Monday, November 13, 2017 9:46 AM
Joined: 2/26/2016
Posts: 59


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.


Lane Simonian
Posted: Monday, November 13, 2017 3:12 PM
Joined: 12/12/2011
Posts: 4038


I am sorry that the company does not have the resources to run an FDA approved trial, but at least it is able to run a trial.  My prediction for what it is worth is that Montelukast should at least be able to help those with asthma and mild cognitive impairment and those with asthma and early Alzheimer's disease.
Serenoa
Posted: Monday, November 13, 2017 4:31 PM
Joined: 4/24/2012
Posts: 470


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.

POLYMORPHISM IN CYTOCHROME P450 GENE IS ASSOCIATED WITH ALZHEIMER’S PATHOLOGY

"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."

http://aanddjournal.net/article/S1552-5260(16)30341-7/fulltext

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.

 


Larrytherunner
Posted: Tuesday, November 14, 2017 3:16 PM
Joined: 2/26/2016
Posts: 59


Lane, because montelukast was approved as a preventive for asthma doesn't mean that it is only useful for people with asthma. It is an anti-inflammatory drug, and as we age, inflammation increases and leads to many different diseases. I don't have asthma and it has made a huge difference in my well being.
Serenoa
Posted: Wednesday, November 15, 2017 5:02 AM
Joined: 4/24/2012
Posts: 470


Here some more evidence that getting rid of Leukotrienes, or blocking their receptors like Singular does, is beneficial in the brain.

Blocking leukotriene synthesis attenuates the pathophysiology of traumatic brain injury and associated cognitive deficits.

"These results indicate that leukotrienes contribute significantly to secondary brain injury and subsequent cognitive deficits."

https://www.ncbi.nlm.nih.gov/pubmed/24681156/


Lane Simonian
Posted: Wednesday, November 15, 2017 9:45 AM
Joined: 12/12/2011
Posts: 4038


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.

https://www.ncbi.nlm.nih.gov/pubmed/24456746

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.


 
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