My husband has been in the Elan trial since July 2008 and has had 3 infusions and of course several MRI's. I have noticed an increase in confusion, some bizarre obsessive behaviours for several day after the infusions. These abate over time but he has continued to decline. His language skills have really gone down and he often needs help dressing. He became very agitated during the 3rd or 4th MRI to the point where they had to stop it because he was moving so much. For the next one they gave him a sedative and he did just fine. Thankfully no bleeding or swelling was seen. Because of his strange reactions following the infusions I feel he must be getting something other than a placebo but then why have we not seen an improvement or at least stabilization. I keep telling myself it took time for this disease to take hold so it will take time to see improvement but it is really hard.
Sorry to hear things are not going well with the trial. As you know, Elan dropped Sid from that trial, but we definitely noticed an improvement after one infusion. I think the improvement has pretty much worn off now. Everyone with AD is different and responds differently to every drug. This is a difficult road we are all traveling.
My DH had infusion # 2 yestereday. Even though he started on anti-depressants two weeks ago he seemed to be in a good mood since he knew he was going to get another shot at this BAP stuff. I have see no improvement with the first infusion so I'm not terribly hopeful but it seems to make him feel better. He's tolerating the Volumetric MRI's and the lumbar punctures just fine and they couldn't be nicer at Georgetown Med Center so he has a good time when he goes. I'm hoping this time we'll see some improvement, or at least a halt of the declining language skills.
I also believe that people are going to react differently since Alzheimer's is a very complex disease. I think that if it could slow the disease down that in it's self would be a miracle.
Inge- I have read that confusion is one of the side effects of Bapinuzamed so perhaps your husband is getting the real thing. My husband has not shown any adverse reactions and continues to do veryly well so far.
I've been filling out the personal and family history for hb today. Realize how little I know and he knows about his family beyond his dad and mom. We have an appointment at OHSU on Thursday for an intake to see if they have any studies he can help them with. Fran has given me some pointers, also about finding out if he can work. They helped her with SS.
Am realizing how little he knows. We called his brother and got the info. Out of 9 siblings on his father's side, 6 had AD. his dad is the only one still living. Don't know how young they were when diagnosed, but since they died years ago, I would say most were in the late 60s early 70s when dying based on his dad's age.
Depending how well he does on their test will assist me in deciding whether to take the summer job we have. I am concerned that he will be overwhelmed with so much to learn. I have a demo of the software that I need to start working on to see if he can learn it. He hates computers and doesn't type - just hen peck. I did apply today for a job that is just what we want - low key. We are praying we get it.
Hi Everyone. I wanted to pass along information about the ICARA (Bapi) study if you or someone you know has a diagnosis of mild to moderate Alzheimer’s.
The goal of the Bapi study is to explore if an investigational drug can help slow the progression of Alzheimer’s Disease. There is no charge to participate, and a medical team, including a physician, will monitor participants throughout the study.
It is important for patients and families affected by Alzheimer's to consider participating in clinical studies. Clinical studies that test new treatments are the best chance we have for fighting this disease.
If you are are advertising and recruiting for a study, you need to e-mail me the information and go through the proper advertising channels. joan@thealzheimerspouse.com
Bapineuzumab is a humanized monoclonal antibody that acts on the nervous system and has potential therapeutic value for the treatment of Alzheimer's disease and possibly glaucoma.[1]
Bapineuzumab is an antibody to the beta-amyloid (Aβ) plaques that are believed to underlie Alzheimer's disease neuropathology. In previous clinical trials for vaccination against human beta amyloid, called AN-1792, patients with Alzheimer's disease using active immunization had positive outcomes with removal of plaques and quality of life increases, but 6% of subjects developed aseptic meningitis and the trial was stopped.[2]
Bapineuzumab is currently being co-developed by the pharmaceutical companies Élan and Wyeth and entered Phase III trials in December 2007.[3]
Had the intake exam at OHSU today. According to them he did worse than in January. On the MMSE he scored 27 in January and 22 today. He was so disappointed and bummed cause he tried so hard. I personally thought he did just as good. I also told him he had to realize that even though worse, it may not be that much worse because each tester evaluates on their own judgment. Also, he was up at 7am when he use to sleeping until 10am. I was surprised because he has been remembering conversations - not that day but the next which he wasn't doing before. I am considering calling the neurologist he saw, that also works with this doctor, and get her opinion.
We sent and spoke with a social worker at the VA. She gave us a guidance on where to proceed for disability. The VA has a non-combat disability pension that he may qualify for. Also, contact the Alzheimer Assoc. and DSHS. I guess they have a program for disabled unemployed workers that often makes it easier to get SSDI. So, I will start working on that tomorrow - just too tired today.
Also, due to these results, sent an email off to the workamper job we had letting them know we can't take it. That it would be too much for him. We did apply for a workamper job that is camp host - low key work that would be no problem.
They offered us two studies. One is the infusion one some here are on and the other is an experimental drug that they hope will dissolve the plaque. We went out to lunch where I explained them to him. The infusion one is out - sounds too scarry. The other one I thought promising. But, he is leaning towards not doing it. When I told him after the 21 months are up the drug will stop and if it did good he could loose that progress and possibly more, he said he would rather go as he is. I will wait a couple days and talk to him again.
and, Charlotte, these ARE just studies,... you cannot be SURE that he'd be better in 21 months when the drug stops. One of the hardest things I have had to do is to accept that this is a fatal disease and there is no known cure anywhere at this time. Many things appear to help slow it down, ...but how do we know it would not have slowed down on its own. As was stated earlier on another thread, this is a disease of slides and plateaus and slides and plateaus. Rarely, have I seen it regress to a better, earlier stage ... for more than a day or so and those are just unexplanable flukes. I don't recall your DH's age, but that also has a bearing on the progress of the disease. Have they said the words, Alzheimers Disease, Frontotemporal Dementia, etc. Forgive me if you've already told others, I've been on this site only a month or so. Hang in there, girl!
Nancy B - we had one diagnosis of probably early Alzheimer but that neurologist didn't seem to know much about it. So we left Nevada and came back to Vancouver. Here is the VA is associated with OHSU so we get excellent care. The Neurologist here in January diagnosed amnesic MCI. Said there wasn't enough to classify dementia. After the testing today where he has evidently progressed some towards AD, I will wager to say he is not one of those that will stay at MCI. I need to contact the neurologist and ask her about the results today and get her opinion. She works with the doctor we saw today, so she knows them. My husband is 61.
Oh no, he is very young! I need to look up MCI again. There are so many kinds of dementia.... I am sorry. Y'all are too young to have to go through this. My DH is 82..but I just turned 70...and feel 50. Who is that woman in my mirror...she's a cwazy wady.
His dad has AD- was diagnosed at 65; his younger sister was diagnosed at 55; his dad had 2 sisters and 2 brothers that also had AD plus their dad (hb grandfather) had AD. My hb has a brother a year younger and so far has no signs. He takes after their mom in health issues, so may escape. Just glad we have no biological children - I could not live with having passed it on.
My husband is in the infusion study(Bapineuzumab) and has had no health problems so far. With a strong family history it sounds like your husband may test positive for the APOE4 genetic mutation. This trial is broken up into two separate studies, those testing positive for the mutation(302) and those who do not have it (301). The Elan's 302 (carrier) study is closed for enrollment but they are still recruiting for the 301 study. I'm not sure if Elan or Wyeth is the sponsor in Canada. Wyeth will also be recruiting worldwide and breaking down the trial in these two separate arms and is lagging behind in enrollment.
Good luck in your decision. I would strongly encourage your husband to participate in these types of studies especially if you have any children. The only way we can end this monster is to support the scientists in research
My husband had his 4th infusion this month and this time we saw none of the confusion and bizarre behviours he showed after earlier infusions. It makes me wonder if he perhaps was getting the maximum dose which is now reduced to 1mg because of problems found with the higher dose. It would be good to see some improvement but at least the decline has been slow.
We only have 2 or 3 infusions left in the BAP trial and I'm now convinced that my husband is either getting the placebo or the vaccine is not working. His MMSE score has gone down by half since the start of the study and there are many signs of decline. He has trouble dressing himself now, is becoming very silent and often confused. He can no longer perform any of the tasks involving his tools, tasks he has performed for almost 60 years. Fortunately he still knows who I am and I guess I'm his security. He needs to know where I am at all times. I'm wondering how others have fared in this trial especially as we are told the vaccine may be available to all those in the study soon. I wonder whether it's worth going with that. Of course if there is nothing else we may not have a choice.
Sorry to hear that news. Trish's husband, Bob, is in that trial, and has been doing well. Sid actually seemed to improve from the one infusion he received before Elan dropped him from the trial. So my guess is that you are correct, and your husband is receiving the palcebo. But you never know - everyone is different, and if it is the real drug, it may not have worked for him. When the trial is over, can they tell you if he was receiving the placebo? It seems to me that you are certainly entitled to that information before you make a decision to go with the vaccine when it becomes available.
Joan, thanks so much for your response. I will ask that question at our next infusion date on July 30th. When he was in the Alzhemed trial they did tell us at the end that he had received the drug but as you know that trial folded. It's good to hear that someone is doing well. It gives me some hope providing it is not too late. He was very tired the day of the last testing so that may have skewed the test somewhat but I can no longer deny what I see in him and what other family members have seen as well. I feel so stressed especially since my 89 year old mom is also declining in health and I just don't know how I'm going to cope.
Is anyone's spouse still participating in any clinical trials? If so how have the results been? There are 2 new trials being held in our area so I've enrolled DH in both for the preliminary evaluation. We'll see if he gets accepted AND if he can tolerate the trial.
My husband was in the BAP trials for several years. We do know he was getting the drug when it went into open label study. He did not improve, but maybe it slowed his progression. Last year we had to stop because he was having other physical problems and it was too much for us to continue. His AD has progressed more rapidly and now has trouble finding words and understanding what I am saying, as well as occasional incontinence. He has no idea of the day, month or year, or the season. He did not know that yesterday was our 51st wedding anniversary, although I told him numerous times. Still, he enjoys going out and seeing other people, although he has difficulty interacting. He eats and sleeps well, but has trouble walking down the block or through Costco. Our time in the BAP study was not a waste of time. He got lots of attention from caring people and I always knew exactly were he was on the AD continuum.
I'm not saying that this is typical, I'm just reporting the facts. My friend's husband was in the BAP trial, and has been on the real stuff for almost a year. His decline has been rapid. Can't say if he would have declined even faster without it, but it surely doesn't seem to have lived up to its hype.
One benefit of NIH trials is the free health care that goes along with it. We didn't participate in any trials but I know people who suggested checking on trials just for the overall health care.
Paulc. beware of what you ask for: submitting you LO to the onslaught of tests including repeated Lumbar Punctures, MRI's hours of psych, mental and physical abilities testing which invariably left us depressed for days back in 2007 is a stiff price to pay for free health care.. The culmination of 18 months of one or twice a month visits was that all my DW's test scores showed consistant measurable improvement according to the research MD conducting the study, as well as all who knew her. At the conclusion of the test, the research MD said the company Wyeth, found that unquestionably the drug Lecozodan, helped a small minority of the patients, not enough to be connerically successful. There was no medication that would be made available to those who benefited on a compassionate basis. The Research MD contacted other investagators onu our behalf and secured us about a 5 mo. supply. We literally searched world wide, called, wrote athe CEO's of Wyeth & Pfizer and received polite, but you're out of luck responses. We were unable to secure any more I find it interesting that no report on the test has ever been published, I think because if the results were known they'd have to complete a costly NDA process for a drug that would only benefit an unprofitable few. 6 yrs later, she disqualified from new drug testing the result of excision of 1/3rd of her liver due to non malignant cysts and being Dx'ed with bowel cancer
As for NIH, and similar. They are VERY nice to you at NIH. I found it well worth participating for the purpose of making the contribution to science, but I knew that after we completed some PETscan-based studies in 2011, that we would never do it again. I'm of the opinion that, in general, these procedures are for AD victims in early enough stages that they understand and are participating willingly and knowingly.