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Sunnybrook's Non-Surgical Alzheimer Clinical Trial
HowDoYouDeal
Posted: Monday, March 4, 2019 11:50 PM
Joined: 2/17/2019
Posts: 183


 

 

https://sunnybrook.ca/research/media/item.asp?c=34&i=1562&page=18496&f=alzheimers-focused-ultrasound-blood-brain-barrier

https://www.clinicaltrials.gov/ct2/show/NCT03739905?term=ultrasound&cond=Alzheimer+Disease&cntry=CA&rank=2

https://sunnybrook.ca/research/content/?page=sri-centres-focused-ultrasound-alzheimers


Larrytherunner
Posted: Wednesday, March 6, 2019 9:00 AM
Joined: 2/26/2016
Posts: 172


I read the article and it seems that they are testing the safety of focused ultrasound to open up the blood-brain barrier. The blood-brain barrier prevents many drugs from entering the brain, and this may be a way to deliver those drugs to the brain. However the trial test only the safety of the focused ultrasound and no drugs are being delivered. Furthermore there is no FDA approved drug for the treatment of Alzheimer's. Sounds to me like this system would be more useful in delivering cancer drugs to brain tumours.

 

It is hard to see how a Alzheimer's patient would benefit from this trial, other than by knowing that he or she is furthering medical research. The blood-brain barrier keeps out toxins, viruses and other bad things. Further there are numerous recent research reports showing that a weak blood-brain barrier is common among MCI, Alzheimer's and dementia patients. Opening up the blood-brain barrier could entail some risk, and there may be little chance of one benefitting from it.


markus8174
Posted: Thursday, March 7, 2019 5:19 AM
Joined: 1/25/2018
Posts: 531


Larry- I'm surprised at your assessment. Aren't you the biggest cheerleader for Montelukast? One of the problems with this and other drugs is the dosage needed to push a therapeutic dose across the BBB. If they can open and then allow to close the BBB there many be a whole world of useful medications for AD and other dementias that in previous trials were toxic to the body at doses needed to treat the dementia. This doesn't only apply to dementias; infections, tumors, toxins....If we can get therapeutic medications safely through the barrier (an I do agree, it's important that the BBB return to closed after treatment) we may be able to save brains from a myriad of diseased.
Larrytherunner
Posted: Friday, March 8, 2019 3:15 AM
Joined: 2/26/2016
Posts: 172


Marcus, there is no problem with montelukast (Singulair), as it is a drug that passes through the blood-brain barrier (BBB). It must be taken everyday to be effective.

This focused ultrasound technology could not be safely used for a drug that a patient takes everyday. Disrupting the BBB everyday would allow a lot of bad things to enter the brain, like toxins, heavy metals, bacteria and viruses. This technology would probably be used for a drug that is administered infrequently, like once every few weeks or once a month. There may be drugs in the Alzheimer's research pipeline that could use this technology, but I believe it is many years away. From what I have read, some drug companies are interested in using this technology in deliver cancer drugs to the brain. They may also want to do research on some of these cancer drugs to see if they could be used as an Alzheimer's treatment. These drugs are not given daily but at longer time intervals.

The company also said on their website that applying focused ultrasound alone has been shown to rescue memory and stimulate the growth of new brain cells in preclinical models. They omitted saying is that these preclinical models were genetically altered mice, which have not proved to be a reliable model in other Alzheimer drug research. Still it may worth looking into.

I really think that this company is trying to determine how often this technology can be used on Alzheimer's patients before bad side effects start showing up, so they can sell the technology to other drug companies. This is something that other drug companies would need to know before they invest in this technology for delivering their own drugs.


Lane Simonian
Posted: Saturday, March 9, 2019 10:51 AM
Joined: 12/12/2011
Posts: 4550


It is rare that I am in complete agreement with you Larry, but your analysis of the limits of ultrasound therapy for Alzheimer's disease is the best that I have seen.
HowDoYouDeal
Posted: Thursday, March 14, 2019 11:48 AM
Joined: 2/17/2019
Posts: 183


Scientist have been studying ultrasound since the 1980's, they already know that ultrasound that is pulsed for too long, or a too high an intensity kills cells by overheating them, that's why they paired it with MRI so they can see what's happening to the cells in real time.

 And that's why they used it to heat and kill specific tissue in people with Essential Tremour.

Ultrasound on its own seems to spur the removal of amyloid from the brain, think of it as giving the cells a little extra heat and vibration/ a bit of an extra kick in the pants to remind them what they are supposed to be doing. 

like....'Hey, you Glial cells, you're supposed to take out the garbage'

The test have to be on genetically altered mice, because mice don't naturally get Alzheimer's, so scientists have done their best to recreate its effects in the brain.

Mice don't have human brains, non-human primates don't have human brains, but this is the process they go through to get any drug or treatment through to human trials.

 

 

 


Larrytherunner
Posted: Thursday, March 21, 2019 5:18 PM
Joined: 2/26/2016
Posts: 172


This is not just about using ultrasound. It is about opening the blood-brain barrier (BBB) and letting in drugs, but also other stuff (viruses, bacteria, metals, etc) that shouldn't be getting through. The whole procedure last about eight hours, so a lot of stuff can get through to the brain during that time.

There are some cancer drugs that might use this technology, but there is the question about the possibility that opening the BBB could increase the risk of developing Alzheimer's. 

I believe that this technology company is trying to answer this question so that they can sell their technology to drug companies developing cancer drugs. This tech company is not going to sponsor a clinical trial with Alzheimer's free participants and have them go through a series of treatments to see if their mental abilities decline and they begin to develope Alzheimer's. So they do the next best thing, which is to take early stage Alzheimer's patients and see if they would decline with a series of treatments, under the guise that it is a possible treatment for Alzheimer's. If there is no appreciable decline, then they can assure the cancer drug companies that within a certain number of treatments, the possibility of the treatments increasing the chances of developing Alzheimer's is small. If, on the other hand, many of the Alzheimer's patients rapidly decline, then it would be difficult to sell this treatment to cancer drug companies because they want to avoid getting lawsuits over patients developing Alzheimer's.

I think the FDA should look at this clinical trial carefully and determine if this is a real trial to evaluate a possible treatment for Alzheimer's, or if there are other motives for having this trial.

There are a lot of glowing reports of new Alzheimer's drugs and technologies being developed. These are often based on press releases put out by the drug companies. What they are doing is selling the potential value of their product and also their companies' stock to investors. So I would beware of a lot of their claims. Further, most of these new drugs and technologies, if they do succeed, will not be available for many years - 5 years, 10 years or longer, and they will also be extremely expensive.

I myself have always looked for what is available now. I am 71 years old now, feel pretty good but if I have to wait until I am 90, I might not be in such great shape (if I am still alive). For now I am taking the generic drug montelukast (Singulair), which is working for me. For now, I am back to normal.


HowDoYouDeal
Posted: Saturday, June 29, 2019 6:43 PM
Joined: 2/17/2019
Posts: 183


Wow, Larry, you're really don't think that the focused Ultrasound could actually be for people with Alzheimer's. Insightec, the company that built the Focused Ultrasound helmet was co-founded by a neurologist, they spent so many years developing the specs for what they needed to build. It was first used on people who have essential tremour, I truly believe this company believes that ultrasound and focused ultrasound are incredibly useful for treating areas that are otherwise untreatable, including brain cancer.

The procedure may take 8 hours from start to finish, but the time that the blood brain barrier is open is, if I remember correctly, it tops out at 3 hour.

  
More importantly, ultrasound stimulates the microglia, they are the brain's clean up crew, if something unwanted gets into the brain during the procedure, I imagine the glial cells will remove that as well, don't you think?