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Hello fellow caregivers. She was diagnosed yesterday with FTD or early onset Alzheimer's and the clinician seems to be in a hurry for a decision. Has anyone taken part in a clinical trial to compare an investigational study drug called BAN2401 to placebo?


Has anyone found it beneficial? I will do anything that will make her quality of life better. Her neurologist prescribed Aricept but the clinician said she can't take that if she is to do the study.


Any and all advice would be tremendously appreciated.

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So far, that I know of, there is no Alzheimer's drugs that are proven to improve or delay. It is difficult to study them due to huge numbers of patients needed in control group. She would be unlikely to take any meds that can help with symptoms. On the one hand we will never have new drugs if there are not brave individuals willing, on the other hand there will be problems with what drugs she can take, with forms, with blood work. And she may not even be on the next "new answer" to care.
I myself would not do it. But others may feel differently. Does your Mom have any input? Is she aware of her diagnosis? Would she have an opinion. Remember, she is getting a drug in a stage of development that leads them to believe it is safe to study in large numbers, but until it is approved it is still experimental.
Good luck with the decision.
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marcieg Sep 2020
Thank you so much! Very straightforward information that will help a lot on deciding. Mom has been gone for 31 years, so no input from her, unfortunately.
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Gee, I'd want a definitive diagnosis before I started anything, and I've always distrusted any pushy sales pitch.
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marcieg Sep 2020
I agree with you as I feel the same way about the pushy sales pitch. How do you go about getting a definitive diagnosis? Her neurologist wouldn't go that far. Maybe time tells?
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Aricept/Donepezil isn’t known to improve FTD symptoms, from what I understand. In actuality, it may increase behavioral symptoms in some people.

But in any case, what you’re asking is so important that if I were you, I’d seek a second medical opinion.
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Don't do it because you think it may improve her quality of life. It may. Actually, what should make the decision is the advances to medical science that are possible. In these trials you cannot even be assured that loved one is receiving the medication or a placebo.

My mom was considered for a medical trial, she wanted to participate but was unable to because she had the APO€ 14 gene. There are qualifiers for any trial. Have you had her screened?
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marcieg Sep 2020
Thanks! That really makes it clear in how to decide. I have not had her screened but after reading through all the paperwork, I think that's part of the initial testing.
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Just my 2 cents,, my dad took Aricept,, we were told up front it is a crapshoot,, may work, may not, no one can prove either way. Did it help my Dad? who knows. So in many ways I feel like it was sort of a "clinical trial" on its own, and no proof either way for us. My MIL had "dementia",, they gave her Aricept for a few years,, again,, no way to know if it helped or not. So why not try the clinical trial? It may or may not help, she may or may not get the "real drug",, but she for sure will get much more testing and all of it will be covered by the study. ( I work at a major teaching and research hospital and have been active in several trials as a clinician) If it does work,, Hooray! You have helped your sister and possibly many more to come. And most studies are limited in time, so you could always start the Aricept once it is over if you think it will help. Good luck,, this disease has no cure.
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marcieg Sep 2020
Thank you so much! This is such a great forum to get advice from people who have been there. I really appreciate your time in writing this. Very insightful.
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Well aricept seemed to help my LO for about a year which I understand is about par.he started namenda which may have helped BUT he was allowed to take his medications after 2 separate trials. I don’t understand why he can’t take it and be in the trial- perhaps another trial?
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marcieg Sep 2020
Glad to hear it helped for awhile. This trial is 18 months long. Is that typical? I believe she can take the Aricept after the trial is over.
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I would be put off by anyone pushing for a quick decision.  Based on one of your answers to other posts, this apparently is quite a long trial.   To agree not to take Aricept (or presumably any other drug) for that long a period, based on an "investigational  study drug" is to me not wise.   

Frankly, I wouldn't agree to anything of this nature.  If I did participate in a drug trial, I'd insist on reserving my right to terminate at will.  (I probably wouldn't be qualified then, but I would never allow someone to supercede my rights to making my own decisions.)

There are a lot of articles on BAN2401:

https://www.google.com/search?source=hp&ei=zFdlX5e_Lqqw5wKrvLaoBQ&q=ban2401&oq=BAN2401&gs_lcp=CgZwc3ktYWIQARgAMgIIADICCAAyAggAMgIIADICCAAyAggAMgIIADICCAAyAggAMgIIAFCkBVikBWCfHGgAcAB4AIABSIgBSJIBATGYAQCgAQKgAQGqAQdnd3Mtd2l6&sclient=psy-ab#spf=1600477136510

I would read at least some of them to learn more about this drug. 

I did find one article with a slightly different focus.  I think it's worth reading:

https://www.fiercebiotech.com/biotech/one-day-after-aducanumab-disaster-eisai-kick-starts-backup-alzheimer-s-drug-trial
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marcieg Sep 2020
Very good advice and I thank you for your time and effort to find articles on the matter. I will read them and learn.
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I worked in a Neurology clinic for years. We saw good results with Aricept. In a clinical trial, she may not be getting the new med but a placebo instead.
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pamzimmrrt Sep 2020
I am really curious ( not judging, really just curious) how did you qualify good results since the progression of ALZ is vastly different for all patients? That is why we were told it was "better than nothing", and at our hospital we have found the same thing.. no way to quantify the results since everyone is different? I also work in a Neuro unit...
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it's a clinical trial so the best thing I can offer is which is better , your sister stay like she is or have a chance that the trial may work?
Also, ask what the worse that could happen doing the trial.

My sister had Cancer and the regular chemo and radiation wasn't working and they gave her just a few months to live and she accepted a Trial and she's still alive and the cancer is in remission and that's been 2 yrs now. Prayers
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marcieg Sep 2020
Prayers. Absolutely! What great news about your sister and her Trial experience.
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We found that Aricept for my MIL withAZ did nothing...except for 2 scary side effects: some morning periods of unresponsiveness (Hospitalized and woke up 90 minutes later) and sudden irritability. If there is any hope for anything positive, I would go with the clinical trial. Best wishes.
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marcieg Sep 2020
Oh that's not good news about your MIL. Thank you so much for your advice and time in responding.
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Studies are great, however... she might get the placebo, meaning she is getting nothing. So your decision is a 50/50 gamble. Give her the Aricept or hope she gets the drug being tested.

I was in a study for breast cancer that I requested to be in. It was a pretty good deal because all I had to do was take the study med for a couple of months before I went over to the protocol drugs for the type of BC I had. I had no reservations in trying it. This one that you're talking about is probably still in the early stages. Even if you opt out of this study, tell the doctor you are interested in future studies that would ensure a newer drug is tested in the patients instead of the placebo for 1/2 the group.
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marcieg Sep 2020
Thank you for the great advice! Since you said "the type of BC you HAD", I hope that means you are now cancer free. I will talk to the doctor about future studies that make more sense.
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Her doctor may have been pushy because trials fill up quickly. Your sister is only 61 and, as long as the rest of her health is good, I think it is worth her participation in the trial. She's already had the misfortune of being diagnosed with FTD and none of the drugs - Aricept included - has been shown to alter the final outcome of the disease. For 18 months at least, she will get excellent care at no cost to her. It is a courageous thing to do being part of a clinical trial but it also comes with a lot of support and information about what is going on with her. If she does it, it will be part of her legacy.
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marcieg Sep 2020
THANK YOU!
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What's the advantage to being in the clinical trial over Aricept? If she's in the clinical trial, she could be one of the subjects given placebo. Is that OK with you? If it were my sister I would do some on Aricept and see if that's a drug I would want her to be given...and not just listen to the doctor. Is she able to make decisions -- what does she want?
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My mother wasn't diagnosed with AD until it was Level 3/4, and Aricept appeared to do nothing for her. She was very sensitive to medications too.
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My hubby was diagnosed 5 years ago with IgA Nephropathy (also called Berger’s Disease) for which we were told there is no definitive cure for. He was offered a chance in a clinical trial, where you either get a placebo or the actual drug being tested. He would probably be on dialysis within a year so We figured he had nothing to lose. After phase 1, he was showing improvement. Was offered to participate in Phase 2, which he did. By the end of phase 2, I was almost sure he was receiving the “study drug” because all his labs were improved. He has been in remission since that time and I am so thankful we made that decision. He has now been diagnosed with LBD, and as his POA if offered a clinical trial I would say “why not”, because none of the medication he’s taken thus far has helped.
Sorry this response is so long but felt it might help Since we have been there. Prayers for you and whatever decision you make.
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Psychotropics only mask symptoms temporarily, and the BAN2401 may mess with her immune system (there are risks with ANY drug, especially experimental ones) or she may be one of the "null hypothesis" or placebo group, which will be nothing more than sterile water. BAN2401 has been experimented with for about 15 years.

https://blogs.sciencemag.org/pipeline/archives/2018/10/25/more-on-ban2401-unfortunately

https://www.biopharmadive.com/news/aducanumab-biogen-alzheimers-drug-ctad-presentation/568583/

If you start looking up things you will find a lot of conflicting information. Bottom line it is a risk taking any kind of experimental drug, and you are dealing with immune system issues.

You also have to remember everybody's Alzheimer's disease (AD) affects them differently, including rate of spread. So even the ones injected with this new "miracle drug" has questionable results.

Some people with AD will have it for over a decade before dying, while others it can kill them within 2 years. My mom had AD for 15 years. She died age 90. She was never on any kind of psychotropics or drugs other than her insulin and lopressor. I walked her in the park everyday for 5 years. She was bedridden for only 3 months due to not being able to focus on the task of getting up and walking. Ironically Alzheimer's did not kill her, but other natural causes. Still she died a very peaceful death, and hospice never had to give her any kind of narcotics to the end.

Let your sister decide what to do. Age 61 is very young which means the course of the disease will tend to be aggressive. Make certain she gets a second opinion of her diagnosis. Other things can cause symptoms of AD such as DEPRESSION and even psychotropic drugs. Doctors DO make mistakes. So that's why a second opinion is important especially embarking on some experimental drug.

Make certain your sister has a second opinion.

Also, there are NO means of diagnosing AD -- only with symptoms. There is no blood test and only brain tissue sample will show anything. MRI will not show anything other than "age related changes" unless they are really in very advanced stages.
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If Aricept or any of these drugs for dementia "cured" it, then you would be able to say definitively whether it worked or not, but they don't.  No one really knows if it staves off symptoms for a period of time or not.  I really don't think she's got anything to lose.  I would try the study if it were me.

Good luck to you and your sister.
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My Dad once my Mom and his doctor recognized his early cognitive limitations at the age of 82 was placed on Namenda and Aricept. He maintained cognitive abilities for most of the 10years after his symptoms were recognized before the dementia worsened and overcame him at the age of 92. Our family believes these two drugs slowed the process down immensely and gave us 10 More wonderful years with him.
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My husband has Lewy Body Dementia... was put on aricept . I found it helped a lot for about a year.
now 3 years later he’s on memantine patch and found it helpful too for about 8 months. There’s no way to know for sure cause it’s progressive disease and can’t reverse it ...and works differently in everyone ...but the earlier they start the
better and longer they work.
clinical trials just that ...and you’re not sure if they’re on the placebo???
good luck whatever you choose.
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You realize that your sister could get the placebo (sugar pill). How will being on a placebo for what ever period the trial is affect your sister's health?
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I had my Husband in a clinical trial.
Part of the criteria was that he was to have been on Aricept for at least 3 months and continue it while in the study.
I honestly think he was given the drug in the study (that was never confirmed as the people administering the drug did not know) I think it probably helped him as he was able to do many things far longer than I expected. But I also think he had Vascular Dementia and the little strokes would lead to a more drastic slide than you would expect with AD.
Personally I think a clinical trial is worth a shot.
Would it be any different if she were not diagnosed until next March? Would 6 months make a difference? Maybe in 6 months the clinical trial would slow the progress.
the big question also is..does Aricept work on everyone? When I took my Husband off it I did not notice a difference at all. (but that my have been because he was in a later stage at that point anyway)
Actually a better question is...How much does your sister understand? have you explained both options to her and does she have any input in this decision?
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How long is the study? If it is a matter of months and less than a year, it may be worth a try. Part of participation is knowing that she may get the placebo. After the study, she can get Aricept. I would love to see more drugs and treatment options that REALLY work for dementia clients, but that requires more studies like the one offered.

How is she being cared for? If at home, does she have enough caregivers to provide 24/7 support or would the study provide that service as part of the agreement.
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This is not a decision to be made lightly or quickly. There is a long road ahead. Anytime a clinician is "in a hurry" to me is a bad sign. God bless the people who are risk takers and willing to participate in the studies...but you are the one likely to be making or helping to make decisions. In our town we have two primary and competing sources of medical care. I would find a neurologist who is experienced in dementias (check with your local Alzheimer's assn, even attend a support group as the members know all the inside poop to get a name) that is NOT from the same affiliation with medical center first one for another opinion. I would also not hesitate to touch base with your own or your sister's or both primary care providers or someone in internal medicine or family medicine. You have time to ask all the questions you want. IMO the Aricept is something people put so much hope in...but often don't see a real difference...though they can. It's an expensive drug and it's hard to finally realize there is not enough difference to keep using it, if any.
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marcieg Sep 2020
Great advice! Thank you !
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Hi Marcieg,
I was diagnosed with early onset ALZ four years ago at the age of 57. I've been a lifelong serious reader. When I was diagnosed, I hadn't been able to read more than 2-3 pages a day let alone remember anything I read. My Neuro Dr. put me on Aricept and told me it could take as long as 6 mos before it might make a difference. Almost six mos from when I started it, I began to be able to read and focus on things in a way that I hadn't been able to for longer than I could remember. About two years ago Donepezil was added to the list of drugs I take. I am also Type II Diabetic, and I have High Blood Pressure, and Neuropathy.
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I have had some friends from my Forgetful Friends Group, who have participated in trials, and they've done nothing to help them. Keep in mind, I am writing from only the patients point of view and what I know from others. I'd go the route of Aricept. Good luck.
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marcieg Sep 2020
This makes me so happy! Thank you so much for sharing the good news that Aricept has helped you. A patients point of view is priceless.
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Imho, I would be a skeptic as the clinician is in a hurry. Prayers sent.
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marcieg Sep 2020
Thank you! Prayers cherished and so appreciated.
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My hubby who has Alzheimer's tried Aricept. He couldn't sleep, it was like he had too much caffeine. It also gave him diarrhea, he has a problem with diarrhea anyway but this made it 1,000 times worse. He tried it for 3 weeks to see if his body would adjust, finally I told him to just stop it. It just didn't work for him.

As you know, Aricept won't cure dementia. The way I understand it, Aricept just masks symptoms. Personally, if she wants to do the study I would say do the study.
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marcieg Sep 2020
Good to know the side effects he had. Thanks so much for sharing.
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My father took Aricept and my wife currently with major dementia has been on similar meds. They say it slows down the progression, but it is imperceptible. I stopped the dollar drain. I would opt not to give it to them if I had a do over. I recommend the trial. Since dementia is irreversible, we need a cure and the trials are one method seeking just that.
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marcieg Sep 2020
Great advice knowing you've been there. Thank you so much!
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Currently there are no wonder drugs for Alzheimer’s/dementia
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I haven't read through all the replies, but I think there's an issue that needs to come first.

You're acting on behalf of your sister, in her best interests, with power of attorney or health proxy, yes?

Then it is up to you to take the decision which, to the best of your belief, is the decision she would have taken for herself if offered this option when she was able to understand it. Did you and she ever discuss medicine, drugs, treatment, the ethics of the thing, your opinions (both of you, I mean) on the subject? What do you think her feelings were about this kind of research? Was she risk averse by nature, or ready to take a chance?

If you believe she would have gone with the trial for whatever reasons - from a desire to contribute to the advancement of medicine to a Hail Mary pass - *then* your next step is to insist that the clinician explain the risks and benefits, in the usual way, before you agree to enter your sister (your protegée, after all) in this trial. You will also want to compare and contrast the risks and benefits with those associated with Aricept.

The easiest way might be to do one of those features charts, like when you're comparing washing machines. I know this sounds utilitarian but at least it lets you see the information you're trying to weigh up.

When you're entering a trial like this, you have to look at the risks on the assumption that you *will* receive the active drug. The placebo definitely can't do you any active harm, even if that's scant comfort; so if you assume you'll get the real one at least you can't have underestimated the risks.
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marcieg Sep 2020
Thank you! Your advice put my head in the right place. Yes, I am her POA for health care. She is still able to make some decisions, with a lot of time and advice from others. I see that coming to an end sooner than later. I have not discussed much with her about "the serious things". I will do that now and take it as serious as it is. Protege. Great way to look at it. I'm only 6 minutes older and not a bit more experienced, but God is able. Thanks again.

P.S. She decided not to go with the clinical trial after all.
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