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I am supportive of my recently Alz diagnosed mother signing up for a clinical trial but so many of the drug trials seem to not have much success. I heard about a device trial that is similar to Parkinson's treatment and wondering if anyone has advice or experience with trials?


The site is www.MildAlzheimersStudy.com if anyone wants to look into it and offer advice.

Sometimes the device has been on the market already for one applicatio but a company sees a new/different application for it. Then they are mostly testing for efficacy (as required by the FDA), and not necessarily safety if that's already been established. There is a lot of progress in neuro modulation (especially for chronic pain treatment), and deep brain stim is part of that.
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Can you find out what the expectations are for the medication? Most current drugs do not claim to cure Alzheimers, only to slow the progression. My mother took an approved drug but her dementia still progressed. It is impossible to know if the progression of the disease was slowed. Some trial drugs may turn out to do nothing. Your mother may be in the placebo group. You have to weigh the risks and benefits for your mother.
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Starrchaser21 Nov 16, 2021
It seems this trial is different as it is not for a medication but a device that is implanted like a pacemaker for the brain. It can be turned on or off as needed etc. I intrigued because I have so much about side affects of the Alz drugs and worry about my mom's other health issues being complicated by side affects. Thank you for your reply!
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My brother-in-law was in a medicine trial in Tampa FL and it extended his mental health for several years. He still declined but it was in tiny increments, It was amazing. However when the trial ended his health declined rapidly and we lost him last December. But my sister had several years with him she wouldn’t have had without the trial.
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Starrchaser21 Nov 16, 2021
It is helpful to hear that some people have had positive experiences in trials. It is a hard reality that the outcome is coming no matter what but having a few extra good years or making some more memories with my kids might help my mom have a more positive ending chapter. Thank you for sharing your story.
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Unfortunately many trials end in failure but without them the few successes would not be found. Far more is becoming known about the similarities between Alz and Parkinsons in early stages, and how to get better diagnosis between the two. I think your mother is loving, giving and very thoughtful of others in wanting to take part in this trial. I would be very proud if it were my mother what ever scientific trial she chose to take part in. And kudos to you for being supportive of her desires. xx
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StarrChaser21: Although I could be incorrect, the clinical trial that you are referencing appears to be related to the Vercise Deep Brain Stimulation System.
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Starrchaser21 Nov 16, 2021
yes you're right, after reading a bit more they are using a Boston Scientific device that is already approved for many other treatments but for Alzheimer's they are still researching.
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My DH and I had each been in several diet trials (cholesterol) before we met. The downside was strict controls on diet other than the test substance, and several blood tests – not a problem for either of us when we were single and only cooking for one. A colleague said he ‘couldn’t do it’ because it involved not drinking alcohol for 3 nights in a row before each blood test! We were interested in the topic, the government agency running it is highly reputable, the staff were great, and parking for the tests was easy. We were very happy with the whole thing, including the information we got about the results of the trials.

My daughter turned down participation in a trial related to dense breast tissue. Although it was necessarily following the right protocols, the specialist running it was not highly regarded by her own doctor, and it seemed to be setting the specialist up to make money from the result. So ask all the questions you want to first, including how much you learn yourself about the results
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Starrchaser21 Nov 16, 2021
That's helpful to know that I should look closer into the clinic/physician also not just the company running the trial. Thank you for your response!
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I am very supportive of trials and studies. I was in one for Triple Negative Breast Cancer to test a pill previously used for leukemia. I did my own research and found the study and it just so happened my doctor asked me about the very one I found to see if I was interested. Seemed like it was meant to be. From time tom time I have been asked to release some of the tissue they stored for further research. Just shortly after I began my own journey, they were making headway with targeted drugs for individual tumors - designer treatment. Even that has come a long way since then for all types of cancers.

I would definitely find out where the device trial is to see if your mom can participate. They will tell you up front if you will be getting the actual device or a placebo device to compare outcomes. If you are in a study like that, you won't know until the end if you got the real thing (as in the real test drug or placebo). If you are for sure going to get the real device being tested, what can it hurt? They will tell you about side effects found in earlier studies.

There are phases to trials - the early trials test the dangers, later they can test doses compared to nothing at all, later it may be to continue with what has worked well so far. If you have a teaching hospital nearby, check with them to see what they have going on. The only way to advance in protocols for disease is to test.
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Starrchaser21 Nov 16, 2021
Thank you for your reply! This is the final phase of the study so you're right it seems they've already proved the safety/dangers portion and now are trying to show different levels for testing.
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You won’t know which group you will be in: placebo or control group. But both have to go thru similar tests throughout the trial, some could be invasive and painful. Read the paperwork carefully to understand the commitments and side effects.
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my2cents Nov 13, 2021
My trial had already gotten past the test drug versus placebo or other protocol, so everyone enrolled when I did got the actual drug. It didn't delay the current protocol at that time - just started with the trial drug and then moved on to the chemo/surgical protocol. I think my preference would be this phase for future trials too.
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Wonderful experience with Columbia Presbyterian in NYC. You feel they care for the patient and the caregiver. At completion of the trial we get the medicine for sure and not the placebo.
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My sister 70 yrs old did a 2 yr clinical trial when her Cancer Treatments of radiation and chemo didn't work and she's in remission.
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Tinderoni Nov 13, 2021
I had a friend do the same thing for lung cancer and she’s in remission.
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By all means sign up for a clinical trial. My wife was in a clinical trial for 3 years and she was stable for 3 years, unfortunately the trial ended prematurely by the pharmaceutical company. And has been declining since
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When you enter a clinical trial, hold on to the contract. It should contain all of the details and risks of the study. Keep it to review. As the trial progresses, the investigators should inform about key observations or changes. You most likely are receiving a free treatment as part of their obligation and you chose this study freely under informed consent. Your contract should state that you can withdraw at any time.
All medication and device studies contain a lot of thought. It had lots of scrutiny by committees for your protection. If there is a problem, the study can be stopped or re reviewed.
As for your question about a device. If it is the same used for Parkinson's, then there is already a large amount of knowlege of its safety. This new study is to see if it can be applied to another disease. So if you are looking to this Forum for someone Sith experience, remember that the size if this forum, is still miniscule in size to the population that has Alzheimer's. That is why I ask that you look at the study for decisions on informed consent. This is an experiment on an even smaller, microscopic group of people.
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Starrchaser21 Nov 11, 2021
Thank you for your reply, I appreciate your insight and advice!
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https://www.fxneuromod.com/advance_study/index.php

This is the web site for the Advance II trial that is aimed at health care professionals. The basic information is that the trial will last 4 years and everyone enrolled in the study will have a medical device implanted. It will be activated right away for 2/3of participant and inactive for 1/3. Then that 1/3 will be activated. It seems the plan is to leave the device implanted when the trial ends.

If you google search the web site you listed, it takes you directly to the questions that are asked if you express interest.
Every clinical trial has questions in advance - some are to rule out anyone who does not the the strict criteria they told the FDA that they would use. Other questions are to rule in those who DO meet all the criteria.
You can start at that point, and go along to see what happens.
You can withdraw consent to the study at any time.
They should give you a great deal of information about the possible risks and benefits of a trial. Be sure that you and your mother have all your questions answered before agreeing....
As a nurse (married to a clinical trials manager), my sense is that I'd ask her primary MD/neurologist about their recommendations, too.
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Starrchaser21 Nov 10, 2021
Thank you! I didn't think to look into the company as well. This is a great resource.
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I am in a clinical drug trial for Parkinson's. I know several people who have had very positive results from DBS surgery for Parkinson's motor symptoms. It's not really for "non motor symptoms " like dementia. Or at least it hasn't been in the past. Someone has to go first. Many clinical trials don't produce the hoped for results. But, someone has to help in the research, to pay it forward. How many experiments failed before the light bulb worked? Don't get involved in a trial unless the person definitely wants to. In my case I'm in a double blind study and don't know if I'm in the control placebo group or getting the real drug. Research is important. Think of all the volunteers for the Covid vaccine drugs. We should thank them. Be sure you understand the trial before you actually have her jump into it. I have not regretted my participation and continue to look for other trials or research in which I could make a contribution.
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Starrchaser21 Nov 10, 2021
Thank you for such a well thought out and considerate response. You have such a wonderful perspective on this!
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