I am putting up some discussion topics carried over from the old boards, so if anyone wants to continue the discussion started there, they can do so here. I'm trying to make things as organized and easy as possible. joang
We are hoping to be participating (we, as in my husband with me doing the driving and scheduling) in the Phase 2 Wyeth vaccine at Georgetown U. in D.C. We didn't make it into the 5th slot for the Merck Phase 1 due to a communications glitch...so right now we're waiting for November to roll around.
That is the trial that Dr. S. wanted Sid to participate in, but he is excluded because of his diabetes. Unfortunately, he is excluded from most trials because of the diabetes.
Dr. Sadowsky has been in this business for about 40 years, and he said that for the first time, he is really excited and optimistic about the new drugs that are in the trial phase now. I don't know if it will be in time to help us.
Some of the articles I have read say that the experts are leaning towards "management" and "stabilization" rather than "cure" in the near future. Similar to what they have done with AIDS.
There are a couple of vaccines in the works. As far as I know, what they are thought to do is inhibit the beta-amyloid protein which is thought to be responsible for the development of plaques and tangles. I don't think anything in the pipeline at present is a "cure."
Both the Wyeth and the Merck vaccines are in the testing phases. Merck is still in Phase 1 (the safety-testing stage,) and Wyeth has done a round in Europe and is on Phase 2--(testing for effectiveness.) The manufacturers engage teams at various research hospitals to run the studies--our site would be Georgetown U. in Washington D.C.
Yes, Tony, I do have information on Flurizan. Two people in my support group are in the trial. After at least 4-5 months on the drug, C. is doing remarkably well. He seems to have "woken up". He is talking more; remembering more; taking phone messages and relaying them correctly. J., however, is going downhill. It seems pretty obvious that C. is getting the drug, and J. is getting the placebo. I believe they both have to be on whatever they are getting for another 18 months. If it is deemed safe and effective, those who were getting the placebo will get the drug. I don't know what happens after that.
I just returned home, so I will be talking to the doctor's secretary on Wednesday about trials for AD patients under 50. I didn't forget - I just got busy and then went away for a week.
From what I've read Flurizan is more effective in the mild stages of the disease. It's a start. There are also several more drugs from others that hopefully will be in Phase II & III at the end of this year.
I have mentioned this before. We are participating in the Alzhemed trial and so far we have not been told that it is ending. However, our doctor did say that he is disappointed in the results as far as my husband is concerned and he is trying to get him into the vaccine trial. The fact that he is still doing relatively well must be due to the combination of Reminyl and Ebixa( Namenda).
From Trish: There will be a clinical trial for phase III AAB-001. This should be anounced in clinicaltrials.gov mid November. There will be 4 arms consisting of 1000 patients each for a total of 4000 worldwide. The 130 sites have already been selected so please contact your neuroligist to see if they will be participating in the study. The cut off age is 50- but they will also have a sub group for familial early onset. I have heard that 75% of the participants will get the open label, 25% on the placebo. The first dosing should be in December depending on the site. In mouse models it stopped the progression but they do not know the results on humans and will not know until phase II results are analysed mid 2008.
I know of two additional clinical trials that shoud be starting at the begining of 2008. I will continue to post about different studies as I find them.
We all do the very best we can as caregivers. It's not our fault if we can't save our loved ones. For me it's raiseing awareness and volunteering to raise money for research. I'm trying very hard to save my husband & if I fail I will continue the fight for my children.
Well, we got the word today. The Alzhemed trial has been terminated. Our only hope now is to get into the vaccine infusion trial some time in the spring. It is hard to know whether this drug benefitted my husband or whether the other two he is on slowed the progression of the disease. In any case, he did not show the improvement that some participants did and I feel for them. To now be deprived of this drug would be devastating.
Hi Joan, I am going to do some more research into this. However my understanding so far is that there were flaws in the statistical model and too many variables, including people staying on the drugs they were already on prior to participating in the study.
The FDA did not approve Alzamed this past summer because it failed to show improvement over the placebo. They are continueing the trails in Europe. From what I've read Neurochem has stopped giving the drug out to the study participants despite the fact that it helped some.
Thanks for that Trish. Our doctor told us that some people did show quite and improvement, so it is very sad for those people. My husband apparently was on the drug from the beginning but even though there was no improvement they still see him as fairly stable. We will never know for certain whether that is due to Alzhemed or the other drugs he is on. I just hope there is not too much decline before the spring when he is supposed to get into the vaccine trial. This is so hard.
We just missed, this summer, getting a spot in Phase 1 of the Merck vaccine trial at Georgetown U. Now we're going back this month because both a Merck and a Wyeth are in further phases. Odds are we'll be in one of them. I have mixed feelings. I know it's not a cure and there's a little grumpy part of me that says "cure or nothing!" But that's silly, and we do want to contribute to the bank of knowledge.
Spent much of today at Georgetown U. Hospital in the clinical trial area. The screening for the Wyeth vaccine looks like it should go well, and we'll be part of Phase 2 imminently. The only somewhat disturbing feature of the day was Jeff's score, 19, on the MMSE. I think that's his worst to date. And he seems so well in so many ways. (Until you ask him to do something, that is.) But conversationally, he's pretty normal lately.
Emily, I wonder if that is the same clinical trial my husband is supposed to be in. Our doctor didn't mention the company name but told us that it wouldn't start before the spring. You guys are always ahead in the U.S. Is it done by infusion? My husband had the same score as yours on his last MMSE and I was worried that he might not be eligible for the trial. In our case it's the language area more than any other that is suffering and he now rarely initiates conversation but will participate to the best of his ability.
It didn't occur to me to ask how the drug is administered, and we're not to that part yet. I assumed it would be a normal hypodermic type of injection, but maybe not.
This topic hasn't been active for a long while, but here I am. Sid MAY have a chance to get into a new vaccine trial (depends on whether they exclude diabetics - we find out Friday). The initial ELAN trial was discontinued because of 18/300 cases of brain inflammation. The new trial is supposed to have that issue fixed.
I want him to have every chance to improve, and he absolutely wants to be in it, but my concerns are:
1. 2/5 chance he will be on a placebo. 2. It's a vaccine that is supposed to attack amyloid protien and build antibodies against them. Unlike drug trials using pills, if it is effective, they just stop after 18 months. They don't continue giving the real vaccine to everyone as they do in "pill" trials. It's a Phase 3 trial, which means if it is effective, it will go to market. Then we can petition our insurance company to see if they will pay for it. 3.I do worry about side effects.
With regard to the possibility of being on a placebo ... my feeling is that Sid wouldn't be any worse off than he is now. In fact, he may actually benefit. Patients can, and often do, improve from treatment with placebos. I don't think anyone knows how or why, yet, but the "placebo effect" is real.
Also, in many trials, after the first "double blind" stage in which some patients are on placebo, all patients are put on the real drug. Would this happen in the trial you're considering?
Are you sure your husband would NEED to continue taking the medicine at the end of the trial? A vaccine is supposed to bolster the body's own immune system, so that it recognizes the amyloid protein as "foreign" and produces its own antibodies against it. We get vaccinated against mumps and measles as children, and that takes care of that. Other vaccines such as the one for tetanus, require "refreshers" every few years. (The flu vaccine is different ... we retain the ability to produce the antibodies, but different strains of flu are involved each year, and so we need new vaccinations against the new strains.)
I would ask whether participants would need additional treatments after the trial is over and, if so, how often. It can take a long time for a drug to come to market even after Phase III is finished. What would happen if a refresher was needed and the drug wasn't available yet? I wouldn't think your husband be any worse off than if he had never been treated, but it's still a question I would ask.
Presumably, if this is Phase III, safety issues have been addressed. Have they given you any details of the Phase II results? What side effects have been observed, and how frequently? Would they be using the same dosing regimen that they used in Phase II, or would there be any differences that might affect safety / potential for side effects?
My husband is in a trial, but not for a vaccine. I don't remember why we missed out on that one -- they were already full, or he was disqualified, or something -- so I never really looked into the one you're considering. The IND he is on (huperzine A) is widely used in China, so I was pretty comfortable that I understood the potential risks of side effects, and they were minimal.
We have been asked to consider participating in two others, and I turned both down. One required that he have several spinal taps, which he flatly refused to consider.
The other required injection of the drug directly into the brain, through holes drilled into the skull. Only fifteen patients had undergone the procedure to date. Two died, from bleeding induced because (they think) the surgery was done using a local and the patients moved. If my husband's symptoms were a lot worse, and if the treatment had the potential to cure AD, I would have given the opportunity very serious consideration. But my husband is still doing fairly well, and the treatment would only slow progression, not cure the AD or even stop its progression, so I felt the risks (especially with the use of a general anesthetic) far outweighed the potential benefits.
I do intend to keep looking for other trials. I don't like the idea of just sitting here letting AD do its worst, without fighting back. Huperzine A is similar to aricept and exelon, just reportedly a bit more effective and better tolerated. I want something that will do more. My husband did not qualify for a couple of trials that were available for drugs that have different mechanisms of action and appear more promising, or we would have chosen one of those.
Waiting for a drug to make it to market will take too long. The huge benefit of participating in a trial is that you do have the possibility of getting access to a new, potentially effective drug years and years before the rest of the world.
Joan: This is my first posting (hope it works), although I have been reading and benefiting from your website since last fall, and emailed Tony directly before his visit to DC with some of my experiences with the EOAD diagnosis process. Briefly, my husband was diagnozed with EOAD at age 53 in January of 2006. He was invited to join the Elan vaccine trial, which I assume is the trial your husband has been invited to join, by his doctors at Baylor College of Medicine in Houston in the fall of 2006. Due to his age, it was the only trial at Baylor that he was eligible for. Since he was so young and very high-functioning (still driving then, but no longer!) I was very worried about the side effects of the earlier trials, and almost cancelled his participation the day before his first infusion. Coincidentally,I was having lunch that day with a close friend who is a breast cancer survivor and very involved in cancer research in the Houston area, and she convinced me to proceed. Tommy was on either the placebo or the vaccine, we'll never know, from fall of 2006 until this past March. He has now received the vaccine one time, although they started him in March with a tiny dosage, and will increase it in June, and again in August. He'll continue until @ Dec. 2009. I am so glad we did this, even though I haven't necessarily seen any improvement, first because my husband feels like he is doing something useful, in fact, he tells all his friends about the clinical trial in detail. I agree with the previous poster that the placebo effect is real, and in his case, maybe just thinking he is doing something useful helps his mental state. In fact, he would get frustrated sometimes at the time the tests surrounding the trial were taking, threaten to quit, and then start talking about the "good" he was doing, and decide to stay in the trial.Second, the entire "team" at Baylor from the receptionist to the #1 doctor there all know us by first name, and my husband considers them his friends, which makes him happy and I know I can pick up the phone and those doctors will take my phone calls. Third, the doctors tell us that their vaccine group at Baylor have had no adverse side effects, but there have been some nationwide, so ask specifically about your site. In summary, the entire process has been very positive for us, but of course we live five minutes from the medical center, so the only downside has been my time off from my job, and my employer has let me become very parttime to deal with my husband. Bottom line, even if this particular trial never actually helps my husband, maybe someday it will help someone else, such as my 21 and 17 year old daughters! I hope these thoughts help, and good luck!
Thank you everyone for your comments and suggestions. I'm still waiting to hear if Sid is eligible. I called yesterday and left a message directly on the voice mail of the woman who explained the whole thing to us, but no response yet.
Sid definitely wants to do it, so I'm going along with it, if they allow him in.
when a patient is in a trial,does he have to discontinue other medications he is on? that is a fear of mine,that he will get worse and there is no going back to better after his memory gets worse. you never know if you get the placebo or the real thing. i have asked our neurologist at vanderbilt about partcipating in drug trials. he doesn't say much about it. i don't understand this,since vandy is a teaching hospital. you would think that they know about and use the drug trials.our next app is july 7th and i need information to talk to dr about. jav
I am on my way out to the gym, but if you will post the State you are in, I will be able to give you more information about drug trials when I return. Are you referrring to Vanderbilt University in Tennessee?
The meds that your ADLO is on will determine whether or not he is eligible for a particular trial. If he is on something that is incompatible with the trial, they simply won't accept him. Sometimes they don't want the patients on a given drug -- and sometimes they require that the patient already be on something. For example, we looked into lecozotan trials; for one, my husband could not be on namenda (which he was, and it was helping), and for another, he had to be on a cholinesterase inhibitor such as aricept or exelon, which he wasn't. So, no lecozotan trial for us... But there are many trials going on, and typically an organization conducting one trial is conducting several, so we simply looked for another IND that appeared promising.
Many trials are set up in stages. The first stage is "double-blind", in which some patients are on placebo, and no one knows which patients are placebo and which are getting the drug. In the next stage, all of the patients get the drug. The trial in which my husband is enrolled is like that -- we know for sure he's been on the "real thing" for 18 months now.
Some trials are set up in which all patients get the drug from the beginning. You have to ask how the particular trial in which you are interested is designed. (Or look it up on the web.)
It sounds as if your neurologist isn't actually involved in any trials? In my experience, even the people actually running the trials have to be bugged, nagged, and harassed to get your LO enrolled. These people are very busy, often teaching, writing research proposals, attending symposia, giving presentations, and conducting research. They are very well-intended but ... you have to be a squeaky wheel.
To find information about alzheimer's clinical trials in your vicinity, go to:
http://clinicaltrials.gov/ct2/home
You can look for trials in Tennessee, and then use the "refine search" button to look for those on Alzheimer's, actively recruiting, in a particular area of TN (enter the name of the city under "Location Terms"), age group, a particular Phase (Phase I is very early stage), etc. Click on a trial that interests you -- there's all sorts of information about the design of the study, who is qualified, what questions they will be trying to answer, duration, etc.
we live in ky. and i am talking about vanderbilt university in tennessee. we are closer to vanderbilt in tnn. than louisville ky. my husbands' neurologist in bowling green ky. wanted us to go to the vanderbilt neurology clinic to see dr. howard kirshner. we have been seeing him most of the time and he is sending my husbands' reports to our family dr. and to his neurologist here.we couldn't get in to vandy until july 7th [unless there was a cancellation,and it was just not possible to get there then] my brother in law takes us. [i just don't do well driving in all that traffic and if i miss a turn i'm lost.] i will try to get more information, if i can on drug trials. jav
Jav: As Sunshyne noted, the drugs your LO can be on depends on the trial. Our experience has been that once you qualify for the trial, then you have to be consistently on the same drugs, I'm assuming because they don't want too many variables. And, in our case, my husband was in the "double-blind" phase of the trial for @ 18 months, but is now definitely getting the vaccine. I may be wrong, but I think all the new participants in this particular trial are getting the real thing? Jav and Joang: Good luck and don't be afraid to be pro-active/ nagging about getting into the trials. We had the opposite experience, Baylor kept calling us, and then once my husband was accepted into the trial, our "new" primary contact at Baylor in Houston for the trial has no other job, that is, her fulltime job is the Elan vaccine trial! and, if we ever need to talk to any of the other doctors or staff there, she makes sure we are able to contact them. But I realize not every medical center/facility may have the staffing to do so.
We are waiting to get into the Elan vaccine drug trial but now I'm terrified that my husband won't qualify. I just spent about an hour with him going over some of the questions on the MMSE and he has definitely lost a lot of ground since the termination of the Alzhemed study. I'm told he can remain on the drugs he is currently taking which seemed to work for quite a few years but I don't think they are doing much good now. What do people think about me coaching him on the MMSE questions? It is so frustrating to teach him how to read the time and I know one of the items is drawing a clock and putting in the time given by the examiner. Any ideas?
That's the same trial we're waiting to hear about - the Elan vaccine. We were told he needs a 26 or LESS on the MMSE in order to qualify, so I don't know why you would want to coach him to do better.
At various different times, Sid has asked me to "coach" him, particularly on the naming animals part, but the doctor needs a true indication of his functioning, so I always refused to provide any "coaching". Not that it would matter, because he would forget it all before we got to the office anyway.
Yes, they did tell us that Sid can remain on the Aricept and Namenda if he is in the vaccine trial.
kelly 5000 CommentTime 19 minutes ago edit delete Hi all:
I need some advice. DH has been participating in a phase II vaccine trial since last January. He had a couple of injections and showed no improvement, just decline. A month or so ago, the trial was put on hold due to someone becoming ill. They determined the vaccine wasn’t responsible and now they’ve removed the hold and DH is cleared for further injections.
Meanwhile, I was contacted by someone from a Dr’s office close to home who is preparing to participate in a phase III trial of a new vaccine that sounds very promising. I can’t remember the full name, but it starts with belze…something. The person I spoke with on the phone sounded so optimistic about this drug. It may not only slow progression, but actually reverse some of the affects of AD.
I know DH isn’t supposed to be eligible for the new vaccine trial if he’s been participating in another trial, but I’m so desperate at this point. I really feel that he may have been receiving placebo. If I get him into this new trial, he may receive the real thing. Couple that with the fact that it’s a short drive from home versus over an hour to get to the current trial. (That wouldn’t matter of course if I thought the drug was helping.)
I don’t know if he can get into this new trial. His MMS is surely below the required 16 and I don’t know if they’ll sort of “coach” him through the questions like the other people did.
Anyways, I was wondering what you think. Should I just continue along with this, hoping eventually he’ll show improvement, or should I try plan B?
We kind of crossed in the mail here. I just moved your comments into this topic - I don't know if you're talking about the same Elan vaccine trial mentioned in the above posts, but 26, not 16, was the MMSE score we were told was the criteria.
The MMSE needs to fall in the range of 16-26. Below 16 they can’t get in. I would suggest going over the MMSE daily if below 16 is questionable. In my husband case he was asked to count backwards from 100 by 7’s, draw two connecting geometric shapes, and questions about dates etc… I had to tell the research nurse not to have him spell “world” backwards since he spent over an hour memorizing it. If there is a time that your husband is more alert (morning or afternoon) you could ask to have the screening then. I believe most trial centers will be accommodating at least ours has been so far. Good luck to both of you.
Our case is even more complicated in that my husband's first language was not English and he is becoming more comfortable in that language. He would never have been able to spell world in the first place and certainly couldn't spell it backwards! Moreover, he gets much more anxious in a clinical setting and I do feel that influences his score. He is still so able in many other ways and it would be sad to have him rejected on the basis of the MMSE score. What will be will be but we hope he gets the chance and I will continue to go over some of the stuff. Interestingly he always remembers what floor the doctor's office is on and is getting much better at remembering the 3 words.
Inge, I've seen papers on "translating" the MMSE for people whose first language is something other than English. For example, sometimes they ask the patient to repeat the phrase "no ifs, ands or buts" and non-native speakers have trouble just because they don't know the phrase; so they've been identifying other English phrases that are more suitable for people who speak a given foreign language. So if there's a potential problem with your husband getting a high enough score, I'm wondering if you can ask for a test that would reflect your husband's capabilities more accurately.
Kelly, is there enough time before the Phase II starts up again for you to find out if your husband would qualify for the other trial? If he doesn't qualify, then your questions are moot. Also, I'd be asking the people running both trials what their opinions are of the the two INDs. They may be able to tell you which one appears the most promising at this point in the process. I suppose they might be biased in favor of their own, but still, I think you'd get some helpful pro's and con's.
frand, while I wholeheartedly agree that you wouldn't want to screw up the trial by getting a patient admitted who wasn't really qualified ... I've seen enough of the MMSE bouncing around all over the place, and being affected by the person who administers it, to think that a set MMSE score is a pretty stupid qualifying factor. IMHO.
I've also seen research studies which concluded that the MMSE can provide insight into the regions of the brain that are affected, but that it can NOT be used to judge the progression of the disease. So people who know a lot more about these things than I do agree with that opinion.
I'm guessing, based on the extensive screening they do for these trials, that anyone who's been a recent participant in a trial will probably be DQ'd, simply because they want the meds to have been on an even keel for quite a few months before a drug trial is started. This is so that it can be assumed that any changes, positive or negative, have to do with either the new drug or normal disease progression, and not something else the person has recently been taking. This is why if you've been (for example) on aricept and namenda, they'll ask that you continue those meds at the same dosage for the course of the trial. We are getting close to the 3rd and final dose of the Merck Phase 2 vaccine (or whatever it actually is,) and it has neither had a positive effect nor slowed progress that I can tell.
I don't know how it works, if there's a database of participants in drug trials accessible to people running trials and they'll find him and disqualify him.
Sunshyne: I don't feel like I can really ask the people running both trials, cause then they would know we're considering switching trials. When I mentioned the new trial to my contact at the original trial, she said that he's not eligible because of his participation in that trial; that was that.
I just made an appointment for his screening on Friday morning. Hopefully, I'll know more at that point. I'm just afraid of making a bad decision, you know? There's no turning back.
This week we had our first screening appointment for the Elan phase III Bapineuzumab trial. I was providing my husband's medical history while another person administered the MMSE in another room. He told me he answered all the questions correctly (Still in denial) but we are continuing with the screening so the score must have been between 16 and 26. An MRI is scheduled for next week and then another screening appt June 30. He tells me he doesn't think he has AD, yet he is willing to participate in the trial if eligible. I feel so sorry for him - there must be so much turmoil and confusion in his head.
Tomorrow is our first screening appointment for the B trial and I continue to be worried. Even though my husband still does so well in many areas( we went to see a play last night which he was able to follow and thoroughly enjoy) I am so concerned about the test. The other morning he had just had his breakfast, shaved and gone for a walk. When he came in he looked at the clock( it was 9 AM) and said. Wow look how time flies - it's almost lunch time- 12 o'clock. We went over big hand, small hand again and I told him it's only 9 so he has lots of time before lunch. I was going over parts of the test with him before but I think that only made him more anxious so I think I will leave it alone. Wish us luck!
I wish you luck tomorrow. Please let us know how it goes. Our first screening for the AAB-001 phase III was last month and I was concerned my husband's MMSE would be to high. He just qualified but we had to go through additional hurdles with other health issues. My husband got his first infusion this week.
It is the phase III bapineuzumab sponsered by Elan/Wyeth. There will be over 200 study sites globaly with over 4000 participants. I believe the cost for this is around 400-500 million dollars. There will be an anouncement on the results of the phase II in June or July. I will post this information as soon as I hear about it. Elan will also be giving a full presentation at the ICAD conference which I think is at the end of July.
My best wishes to you & Inge in getting your husbands in to the study.
trish, how exciting. This really does look like a very promising drug. Please let us know how it goes!
My husband just finished the huperzine A trial last week. He'd been on the drug for 72 weeks, and might have been on it for six months before that (the double-blind placebo period). I had hoped they would decide to extend the trial again -- they'd already extended it twice because the results were very promising -- but no dice. The good news is that huperzine A is sold over the counter, as an herbal supplement, so my husband can continue taking it. We have to pay, now, of course -- but a two-months' supply is $10, so I think we can handle that! :-)
They are just starting to recruit for bapineuzumab here, but my husband would have to stop taking the huperzine A, since it is considered investigational even though it is the same type of drug as aricept and exelon (either of which can be used by patients in the bapineuzumab trial). They strongly recommended that he continue the huperzine A, since his test scores have held steady during the last year, rather than stop it and try something new and more risky. And I agree with them, don't rock the boat if things are going well.
Still, I will continue looking for additional things we can do, to try to actually reverse the damage that has already been done.
I have been reading about "brain placicisty" which in my opinion will be the the next step after a disease modifing is approved for Alzheimer's disease. Dr. Merzenich has been a pioneer in brain plasticity research and I have posted a link to his website.
http://merzenich.positscience.com/
For my husband's birthday I bought him a Nintendo brain age game. He truely loves it and will often spend several hours a day doing various games. One day this week his brain age was 42. LOL.
I don't blame you- if huperzine A is working why take him off of it? Early on we tried Ginko but ot upset hubby's stomach.
Trish, I just read his "A message from the isles" blog and he had me rolling in the aisles. I do believe I must explore the man and his theories a bit more. Although he sounds much too practical and down-to-earth (and outspoken) to survive in the scientific world!
Thanks!
I'm more interested in finding a Nintendo game that will make my body age 42. You got one of those to recommend? Seriously, though, I am going to look into your suggestion. My husband is bored and I have trouble finding the time to help keep him occupied. If he could spend hours outdoors, it would be a different matter, but with the problems he's having with skin cancer, that's out of the question.
God How can I find out about some of these trials and new med. Kelly5000 where were you bringing you husband I live 10 miles from you. My wife is 79 and has been on Aricept and Namenda If something else is available where.