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New Montelukast clinical trial at Emory University
Larrytherunner
Posted: Tuesday, July 23, 2019 2:32 PM
Joined: 2/26/2016
Posts: 178


I have some incredible news. Emory University in Atlanta, GA is expected to begin a clinical trial this month for montelukast (Singulair) as a treatment for Mild Cognitive Impairment (MCI) and early stage Alzheimer's. This is going to be the kind of trial that can be done when there is lots of resources and money available. It is going to be big.

 

One big factor is that they have gotten permission from the FDA to use dosages up to 40 mg per day, which is greater than the FDA approved dosage of 10 mg a day for asthma. This to me is understandable because montelukast has been available for more than 20 years and has a very good safety record for long term use for adults. Evidently they will be doing the safety and treatment in the same trial. 

 

From my own experience of taking montelukast for over three years, taking 10 mg once a day helps but was not enough to get me back to normal. I was back to normal at 10 mg twice a day. I now take 10 mg three times a day and also sleep much better and feel great.

 

If you compare the Emory trial and the Intelgenx trial in Canada, you can see big differences, which I think is due to Emory's vast experience in conducting clinical trials, its available money for research, and its relationship with the FDA. 

 

Here is my comparison between the two trials:

 

Emory enrollment is expected to have 150 patients. For the Intelgenx Canadian trial, it is 70.

 

Emory will administer various mental and psychological tests at various intervals, as will the Canadian trial.

 

Emory will measure amyloid and tau at the beginning and after 12 months of the trial. This will not be done in the Canadian trial.

 

Emory will administer additional lab tests for safety, which will not be required in the Canadian trial.

 

Most importantly Emory will dose patients up to 40 mg per day, whereas the Canadian trial is limited to 10 mg a day, which is the current FDA approved dosage for asthma attack prevention.

 

The Emory clinical trial is a surprise for me. My daughter graduated from Emory and went on to the Medical College of Georgia, where she graduated as a medical doctor and is practicing in the Atlanta area.

 

Emory university trial https://clinicaltrials.gov/ct2/show/NCT03991988


markus8174
Posted: Wednesday, July 24, 2019 8:58 AM
Joined: 1/25/2018
Posts: 535


Larry- that's great news !!  Although the Canadian trial offered some hope, a trial in the US by a major university will be much more effective in getting PCPs to consider Montelukast as a treatment option. From what I an tell, the current stage if investigation does not attain the level required for the "Right to Try" regulations, but this does move us closer to having Montelukast available to patients.
Birdies
Posted: Wednesday, July 24, 2019 1:38 PM
Joined: 7/3/2018
Posts: 57


Marcus, 

Is your wife still on monteleukast?  Have you seen a difference if so?

I see that the requirements for study are MCI, - my mom is somewhere in Stage 6, - not sure the monteleukast would help at this point.


markus8174
Posted: Thursday, July 25, 2019 9:47 PM
Joined: 1/25/2018
Posts: 535


Birdies- yes, my DW is still on the Montelukast. Our Primary doc prescribes 10mg at bedtime. I give an additional 10 mg with her AM meds. I've gone up and down on the dosage,  but see little improvement at her current stage of progression. The only way to be sure it is or isn't helping is to stop it and see the results. Unfortunately, the purpose of Montelukast is to reduce inflammation. If I allow the inflammation to reoccur, I may be allowing damage that is irreparable with what little mind my DW has left.  It's cheep, well tolerated, helps her breathing problems, and may be having a positive impact on her AD. We've got nothing to lose.
Birdies
Posted: Friday, July 26, 2019 3:16 PM
Joined: 7/3/2018
Posts: 57


Thanks for the thorough response Marcus
Larrytherunner
Posted: Saturday, July 27, 2019 10:39 AM
Joined: 2/26/2016
Posts: 178


Hi Marcus. My understanding about "right to try" is that it is for drugs that are going through clinical trials which has not been completed and the drug does not have FDA approval for any medical condition, and therefore, it is not on the market. The patient may need the drug now but it may be years before the drug is approved. A right to try law allows the patient to get the drug if the drug company and physicians agree to it.

The best solution I think is that it would be approved as an over the counter (OTC) drug. Merck applied to the FDA for OTC status just before its patent ran out. Although the drug had a very good safety record for long term use, the panel was concerned about some reported side effects experienced by children. Further they were concerned that some users would mistakenly take it as a rescue drug for asthma attacks, and therefore delay getting appropriate medication. Montelukast is not a rescue drug but rather is used to reduce the number of future attacks. The OTC application was disapproved.

Perhaps as the clinical trials progress and more news gets out to the doctors, more doctors will be willing to prescribe it. If the trials are successful, then it will become a standard treatment. Hopefully one day another drug company will apply for OTC status, and this time it will be approved. I feel lucky that I live overseas in a country where this drug does not require a prescription.

montelukast_fda_says_no_to_otc

https://www.medicinenet.com/script/main/art.asp?articlekey=178329


Genericuser8888
Posted: Saturday, July 27, 2019 4:04 PM
Joined: 4/4/2019
Posts: 4


Larry,

I want to quote your post and give you a few more details. 

"One big factor is that they have gotten permission from the FDA to use dosages up to 40 mg per day, which is greater than the FDA approved dosage of 10 mg a day for asthma. This to me is understandable because montelukast has been available for more than 20 years and has a very good safety record for long term use for adults. Evidently they will be doing the safety and treatment in the same trial."

-- The trial in Canada uses oral film technology.  Pills have to go through the stomach and liver before hitting the bloodstream, so they lose a lot of their potency.  This is called the "pass-through effect".  The trial in Canada using oral films can make use of smaller doses because the medicine is absorbed straight into the bloodstream through capillaries in the mouth.  So, a 10mg oral film is like about equivalent to a 20mg pill.  And, the oral films work much more quickly because they hit the blood stream faster.  Also, just so you know, I have been in contact with the company, Intelgenx, and the Canadian trial can dose up to at least 30mg twice a day using the oral films. So, if the 10mg film isn't enough,they can actually go much higher.  30mg of oral film would likely be equivalent to a much stronger does in pill form.

 "From my own experience of taking montelukast for over three years, taking 10 mg once a day helps but was not enough to get me back to normal. I was back to normal at 10 mg twice a day. I now take 10 mg three times a day and also sleep much better and feel great."

--I do wish the Canadian trail would allow dosing of up to 3 or 4 times day as needed, but to the best of my knowledge, they are only allowing 2 doses a day.  Do you know how many doses a day the Emory trial is allowing?

 "If you compare the Emory trial and the Intelgenx trial in Canada, you can see big differences, which I think is due to Emory's vast experience in conducting clinical trials, its available money for research, and its relationship with the FDA."

--Good point here, but the best thing about the Canadian trial is that it is already underway and we will send mid-point results in October 2019. 

"Most importantly Emory will dose patients up to 40 mg per day, whereas the Canadian trial is limited to 10 mg a day, which is the current FDA approved dosage for asthma attack prevention."

--Larry, you are misinformed here, likely due to the limited publicly available information.  I am a stockholder in Intelgenx, and I have emailed directly with the company about this because I, too, was concerned that the small dosing would make the medicine ineffective.  I was informed by the company that 10mg of the oral film is the regular **starting** dose, but they have permission to go up to 30mg twice a day using oral film, which is likely the equivalent of much larger (say 40mg to 60mg) pill.  So, they are using 10mg a day, possibly twice a day (likely the equivalent of a 15mg or 20mg pill twice a day), but can actually go up to 30mg twice a day.   To the best of my knowledge, they don't plan on going up unless the small doses are ineffective.

I would love to hear from someone in the Canadian trial.  I'm curious as to how it is going.


Larrytherunner
Posted: Sunday, July 28, 2019 12:21 PM
Joined: 2/26/2016
Posts: 178


Genericuser, thanks for telling me more about the Intelgenx sponsored montelukast trial. I was basing my comparison between the two trials on information from clinicaltrials.gov. It's great to hear that the Intelgenx trial will be allowed to increase the dosages at a later date.

 

Because the montelukast Versafilm disolves and enters through capillaries in the mouth and enters into the bloodstream without first going through the digestive system and liver, more of the drug reaches the brain. The phase 1 study showed that Versafilm had a 52 per cent higher bioavailability than regular tablets. Doing the math (10 mg x 1.52 = 15.2 mg), one 10 mg Versafilm strip is the equivalent to a 15 mg tablet. A further advantage is that Versafilm is helpful for patients that have difficulty swallowing tablets. 

 

Clinicaltrials.gov doesn't say if Emory will be giving divided doses throughout the 24 hour period, but I assume they will. Montelukast has a half life of only about 5 hours, so it is rapidly removed from the bloodstream, indicating that multiple dosages would be necessary.

 

Intelgenx has a headstart over Emory. I hope that the Intelgenx's planned report on patients at the 26 weeks halfway point in October will be positive. I believe that whichever trial is completed first will make headlines around the world as proof of the first effective treatment for Alzheimer's.

 

 


LizzieC
Posted: Tuesday, September 3, 2019 9:50 AM
Joined: 3/28/2018
Posts: 230


 https://www.clinicaltrials.gov/ct2/show/NCT03991988

Note the section labeled Emerald on the Emory site:

http://alzheimers.emory.edu/research/clinical_trials/mci.html

 

PCP prescribes my husband is 10 mg/daily of Montelukast.  Who know if it is helps, but he has been on a plateau for some time.


Larrytherunner
Posted: Thursday, September 5, 2019 6:13 AM
Joined: 2/26/2016
Posts: 178


Lizzie, I am glad to hear that your husband's doctor was open to prescribing montelukast, and that your husband has not declined. My experience is that montelukast at 10 mg twice a day works much better than a once a day dosage. I myself am now taking it three times a day with no bad side effects.

 

We should know more about the effectiveness and dosages next year from the trial in Canada and from the trial at Emory University in Atlanta. A report at the half way point is expected to come out from the Canadian trial this October.


Genericuser8888
Posted: Saturday, September 14, 2019 9:18 PM
Joined: 4/4/2019
Posts: 4


At a conference last week, Intelgenx said they had contacted Emory and are discussing partnering with them in some fashion.  Something may or may not come to fruition as a result of those talks, but I see it as a good development.
Larrytherunner
Posted: Monday, September 16, 2019 5:38 AM
Joined: 2/26/2016
Posts: 178


Genericuser. I am glad that Intelgenx and Emory are talking about working together. Emory is already planning to do a safety trial for dosages up to 40 mg a day, which I assume would be multiple doses each day. From my experience, multiple doses per day will give the best results. If Emory is willing to share the data, Intelgenx can get their montelukast product much sooner to patients. Thanks for giving us an inside look into what going on in these clinical trials.
Larrytherunner
Posted: Friday, October 11, 2019 11:06 AM
Joined: 2/26/2016
Posts: 178


More news on the trials. Representives of Intelgenx have met with Emory officials about cooperating on data from the two trials. Also Intelgenx, whose clinical trial is being supervised by Canada Health, an agency of the Canadian government, is making an application with the FDA for a clinical trial in the US.

An agency of Canada Health has found that the ongoing clinical trial has turned up no safety concerns, which is no surprise since montelukast had already been approved by the FDA as a treatment for asthma more than 20 years ago. Hopefully there will be a midpoint evaluation on the drug's effectiveness soon.

Dr Ludwig Aigner, the researcher who found positive results using montelukast in animal models of dementia in 2015, has recently shown in further animal studies that multiple doses are significantly more effective in treating dementia than once a day dosing. This indicates that multiple dosing is the way to go in the Canadian and Emory trials. I found this out more than three years ago when I went from one 10 mg tablet to two and then three tablets a day.

Just one more thing. I forgot to mention that Emory will do neuroimaging (cerebral perfusion and markers of vascular brain damage). Neuroimaging is very expensive and often not done in clinical trials involving Alzheimers and dementia. Emory has gone all out to see that this trial is done right. And the surprising thing is that Emory is paying for the trial itself. Usually when a university conducts a clinical trial, it is paid for by a drug company or has other for-profit or non-profit sponsors. Evidently the people at Emory have confidence that their trial will succeed and are willing to pay for it.