Since my husband has been involved in the earlier phase of this study for 3 years, we have had a couple of things come up in that time...always a hassle! I needed to report any dental work beyond cleaning... if he had a tooth filled, I had to have the dentist write down what kind and amount of novacaine was used. If he had a headache and I gave him an aspirin, the date and what and how much he had. He needed a root canal; I didn't "pre-clear" the procedure; I just had it done and told them afterwards what he had had. The earlier study had many more appointments than it appears the current one does (probably determined many of them were not necessary) and after jumping through hoops for the first couple of years, I decided our whole life could not revolve around the study quite so much...if he needed a root canal, he needed it. None of the things he had done (flu shot, for example) forced him out of the study.
His seizure did mean no more investigational drug. I am sure there are other things that would also prevent continuing; however, there are other things that are also important to our loved ones well-being.
My DH is at 18 on the testing and hast year he had a bad tooth and his dentist recommended a root canal and cap or pulling the tooth. The dentist and I agreed considering his condition and it wasn't paining him now to let it ride. Good or bad decision I don't know but I couldn't see doing all the expense of a cap now.
The test coordinator did not come out and say he would be dropped if he were to have dental work. The sponsor needs all the information about treatment. Apparently, any treatment could cause changes in his MRI. We have to go on with treatment, even if it means DH is out of the study. Our hope is that he will be able to continu. Maryd
Leelyle, there may be three things going on. First, any clinical trial will want exhaustive details about anything that might affect a participant's health (nutrient supplements, illnesses, accidents, whatever.)
Second, dietary and environmental exposures to some metals have been implicated as risk factors for developing AD. Some metal ions promote the formation of neurotoxic Abeta oligomers in in vitro (test tube) experiments. Metals such as copper and zinc bind to beta amyloid plaques, and the metals are found in higher concentrations in damaged regions of the AD brain. Some researchers are exploring the use of metal chelates (compounds that bind metal ions very tightly, to either prevent them from binding to biomolecules in the body or perhaps even remove them from biomolecule-metal complexes that have already formed) for treating AD.
I don't recall having heard anything about mercury being a problem, but a lot of dentists still use amalgams that contain mercury, and that mercury can leach out of the filling. Lots of people think too many dental fillings can pose a health problem, even in healthy people.
Many scientists feel that the studies that have been done offer compelling evidence that dental amalgam is NOT a major risk factor for AD. However, mercury not being a risk factor for developing AD is not the same thing as mercury possibly interfering with bapineuzumab treatment. (I wish they'd come up with a different name for that drug! I have to look it up every time.)
Crowns can be made of metal, porcelain-fused-to-metal, all resin, or all ceramic. Metals used in crowns include gold alloy, other alloys (for example, palladium) or a base-metal alloy (for example, nickel or chromium). I don't think any of those have been implicated in AD, but I haven't really checked.
Third (which I never would have thought to check out until maryd's last post), dental metals can indeed affect MRI results. If the patient started out with permanent metal implants etc, then the MRI would stay the same, and there wouldn't be a problem. However, a change in the dental metal content might alter the MRI.
One study that I found says that gold, silver, a gold-silver-palladium mix, and amalgam did NOT affect the MRI. Nickel-chromium, cobalt-chromium and SUS304 (whatever that is) caused small effects, but SUS405, palladium-cobalt-nickel and Sm-cobalt caused significant effects. If the latter must be used, then see if he can get a removable prosthesis. (Still, be careful about what is used in the crown that supports the removable bridge.)
Anyway, check with the dentist about the types of materials s/he proposes to use. See if you can avoid the metals that affect dental MRI, or get a removable bridge. And see if you can avoid copper, zinc, mercury, and iron that might be neurotoxic.
Maryd, Thank you and your DH for participating in the studies. It has to be hard to be afflicited with AD, and then to go through the appts, MRI's, etc., added to that, must be very trying. Hopefully with your help and that of others, AD will be controlled if not beaten in the very near future. There are Far too many Very young people with AD. It breaks my heart to know of sooo many younger ones having to deal with this. It seems like more & more are joing this site every day. I'm glad they participate here, but the expansion of the younger age group is upsetting.
Sunshyne, again Thank you for the Enlightenment Its not flattery Its truth.........
My husband & I are part of that young group. He is 54 and I am 45. He was diagnosed w/ EOAD last Dec and even though on meds that keep him pretty stable he's still slipping a little at a time. He's very aware of what's happening to him and feels so frustrated. We have been being put off for three months on the Elan study at Hopkins and now they tell us it is on indefinate hold due to some problem with the lawyers and the negotiating......UGH. My husband is crushed and is now hoping I can get him into something at Georgetown Univ. He doesn't even care what it is at this point as long as he can feel like he's doing something instead of waiting around for his brain to waste away. I kind of agree with him. This is so frustrating. When Hopkins first told me last week the Elan study wasn't going to happen, at least not for a while they offered up a few other choices. One by one we were shot down because he has asthma, or he is three months too young for the minimum age or something else. Makes me want to scream, or just rollup in a ball and hide under the covers. Unfortunately, I can't afford to do that with him needing assistance and we have two younger children who need me too.
For anyone working with Georgetown Univ Memory Center: Do you have any hints, contact names/numbers, words of advise?
Oh, hey, they've just announced a new RAGE Phase II trial, and they're accepting patients over age 50 with mild to moderate AD (MMSE score between 14-26 inclusive).
http://explore.georgetown.edu/news/?ID=36626
Also go to:
http://clinicaltrial.gov
and search for: NCT00566397
It's not open to familial (inherited) AD, patients with diabetes mellitus Type 1 or Type w, or those with a history or symptoms of autoimmune disorders.
I was going to look into this trial in more detail for my husband. The little I know about it sounded quite promising. I'll let you know what I find.
Welcome brookhvn1, I can't offer any advice on trials as my husband was too far advanced at diagnoses... but I did want to welcome you to "Joan's place" There are others here involved in trials and I am sure they will be along shortly to assist you. :)
Georgetown is recruiting for bapineuzumab, have you tried them? They have a couple of trials: NCT00575055 NCT00574132 Both of these are supposedly open to patients 50 years old and above.
Let me know if you want help tracking down the people to contact.
There are two other trials still recruiting in the Washington DC area which are accepting patients 50 years old, MMSE scores 16-26 inclusive:
NCT00568776 Phase II trial of ELND005 (scyllo-inositol) by Elan Pharmaceuticals. Don't know anything about that, will have to check further. Stable doses of cholinesterase inhibitors and Namenda allowed. Can't have a "significant medical illness", you'd have to see whether asthma counts.
NCT00498602 Phase II trial of ACC-001, which is another immuno-type drug -- that's what bapineuzumab is. Will check into this further, too.
Not right now, though ... my husband has been promised pizza and he's pacing. <grin>
Welcome Brookhavn1, I am sorry you have the need to join us, however, you will find everyone willing to help. Sunshyne, a wonder in researching. My husband is 57,recently diagnosed with FTD. You might like to check out the What Are The Ages & Where you are from post. Again welcome.
Welcome to my website. Please be sure to log onto the home page - www.thealzheimerspouse.com - and look at all of the resources on the left side. If you scroll down near the bottom, there is a section to click on to find drug trials in your area.
My husband is a diabetic, but was accepted into the bapineuzumab (better known as BAP III trial). It was just about the only one that would take diabetics.
You will find a lot of love, support, and information here. We are all spouses, so we understand the unique issues that go along with having a spouse with Alzheimer's Disease. There are also a lot of members here who are struggling with EOAD and are in your age group. If you go to the top of this page, and do a "search" for EOAD, you will find at least 4 topics, and there is a section on the left side of the website specifically for EOAD.
Many thanks to you all for the warm welcome and especially for the research Sunshyne. I have his history put together to fax to the study coordinator at Georgetown tomorrow AM and I'll follow up with her by phone. I'm at the point that if they don't return my phone call I'll walk into the office. THey are 10 minutes from my office.....but I'll hold off on that...don't want to seem like a crazy person just yet.
I'll keep you posted as to the progress.
Thank you again for your support. It's nice to know I"m not alone our here. I miss having him help me make decisions like which study to pick and which path to take. We used to make all these decisions together but now he counts on me to take care of this stuff. It's tiring being "in charge" of everybody now.
Bad news on the BAP III trial. The doctor just called me. Sid's latest brain MRI showed some slight abnormalities. Elan is concerned about the risk of the infusions causing bleeding in the brain, so even though the abnormalities were slight, they are pulling Sid out of the trial. We are disappointed, of course, but I am very glad that Elan is being so careful.
FYI - for those of you whose spouses are in the BAP III trial, Elan is carefully reviewing the MRI's of all 1000 participants, and will stop the trial on anyone whose brain MRI shows the slightest abnormality.
I am so sorry. I know how much you were looking forward to the trial. Perhaps you can find another that will accept Sid. The only upside is that he is now free to switch meds, as needed, and, if you wish, add vitamin D.
I'm very sorry to hear your news. I have been following your journey down the ELAN road for months as my husband and I are on the same road just further behind.
I had actually just logged in to update the group on our progress and ask a question. I managed to get an appt for screening at Georgetown for the same ELAN study on Oct 14, the same day we would have done it at Hopkins had they not halted their participation in this study. After careful reading of the consent forms, however, I see ELAN is not picking up any costs related to complications form the infusion. Is this normal? I did read a Merck consent the other day on another study that said they would pick up any/all costs on complications and the treatments could be done at Hopkins. WHen I asked the NP at GU about it she said it was normal for the sponsoring company to not take responsibility for any complication costs/treatment. My insurer sure won't pay for stuff if they even catch a wiff of experimental drug.
Is this just a risk I'm going to have to take? What has been your experience with other facilities/hospitals and other studies? Maybe I"m worrying about nothing as we can see from Sid's case that ELAN will yank anybody out if there is the slightest bit of trouble. Your thoughts folks???
Gammagard is approved by the FDA as safe for treating certain immunodefficiency disorders. This implies that the main question is how Gammagard helps fight Alzheimer's. Many of the basic safety and side-effect issues that can derail or delay a new drug have already been approved by the FDA.
The decision to support a multi-center Phase III study was based on results of two completed, open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial. The Phase II study follows an earlier Phase I study in eight patients that was published in the journal Neurobiology of Aging in February 2008. The 12- to 18-month results of the Phase II trial will be available later this year.
“This was the first placebo-controlled clinical trial of Gammagard for Alzheimer’s disease and the results are clearly promising,” commented Dr. Norman Relkin, the New York trial's lead researcher. Dr. Relkin is director of the Memory Disorders Program and behavioral neurologist and neuroscientist at New York-Presbyterian/Weill Cornell Medical Center, and associate professor of clinical neurology at Weill Cornell Medical College in New York City.
The Tennessee study showed that Gammagard contains naturally occurring antibodies that directly bind to different forms of beta-amyloid protein, including oligomers and fibrils. “Observations from this study provide insight into how Gammagard-Liquid may be of potential clinical benefit for Alzheimer’s patients,” said Dave Morgan, director of Neuroscience Research, University of South Florida. “This study suggests that Gammagard-Liquid may target the primary pathway involved in Alzheimer’s disease and justifies additional studies to evaluate whether Gammagard-Liquid can effectively reverse the effects of Alzheimer’s disease.”
The preliminary 6-month Phase II results suggest that levels of antibodies against beta-amyloid increased in the cerebrospinal fluid and blood of patients treated with Gammagard, while the levels of beta-amyloid in the blood increased. Beta-amyloid is a substance thought to contribute to Alzheimer’s disease. Clearing this substance from the central nervous system, therefore is hypothesized to help remove or reduce the building blocks of Alzheimer’s.
What I found most exciting was that Gammagard-treated patients had observable changes in brain metabolism (PET scan). Energy metabolism in the brain was preserved or improved in 10 out of 13 patients after six months of Gammagard. Brain metabolism usually decreases progressively in patients with Alzheimer’s disease. In addition, FDG-PET scans showed that Gammagard-treated patients showed 16 percent higher brain metabolism after treatment compared to placebo.
The study also met its endpoint in assessing the tolerability of Gammagard in Alzheimer’s patients.
The Phase III trial is a prospective, 18-month, randomized, double-blind, placebo-controlled, two dose-arm, parallel study in 360 subjects of both genders, ages 50 to 89 years old, with dementia of mild-to-moderate severity. The study will determine whether GAMMAGARD LIQUID treatment results in a significantly slower rate of decline of cognitive and other functions compared to placebo. Approximately 40 U.S. leading academic centers have been identified and will begin clinical trial enrollment within the next several weeks.
That is a very good question about drug companies not paying for complications. I did read about it in all of the consent forms. If Trish is reading this, maybe she can answer. It is something I need to ask because if you read my notice on the home page yesterday, I said that Elan was offering to see Sid for the rest of the trial time (16 months) on the same schedule of cognitive, blood, and MRI testing to make sure he is okay. I agreed, because, why not? Let them pay for all of that stuff for 16 months. BUT, I DID NOT ASK what happens and who pays if they DO find a complication. I will definitely check that out at the next appointment.
Wow, not paying for complications is new from the previous stage of the study! This is directly from the forms we had to sign "If you are injured as a direct result of the study drug or the procedures required by the study protocol, you will be treated at no cost to you. The study sponsor will pay for the costs of this care."
What must have happened is that it is so difficult to determine if something is a direct result of the study drug. When my husband had his seizure, it was determined it was more likely than not a result of drug...but there is really no way to know, since seizures can be from the Alzheimer's itself. On the other hand, the study requested he be taken to ER and MRI, EEG (is that the brain one?) and some other things be done. They wanted to see the results of all the tests. My understanding is that they paid for it. I know we didn't. It seems there was some controversy between Elan and the university who was administering the study on which of them were responsible for payment. I don't remember ever hearing who actually paid for it.
I am so very sorry to hear that Sid can not complete the study. I know that Elan/Wythe are being overly cautious with the safety issues so that they can get approval from the FDA. The sad fact remains that there are no surviviors with Alzheimer's disease.
My screening consent form states:
Provided you have made every reasonable effort to obtain the insurance benefit, you will be reimbursed by the Sponser for any medical expense that you incur as a direct result of the study drug or procedures required under the protocol that are not covered by insurance.
The person from GU called me back yesterday with a clarification and brought my attention to the paragraph that you listed above. She was unclear too and was glad I asked. I guess if there is a problem and my insurance wont' pick it up, and they won't because it's an experimental drug, that clause in the consent puts the expenses on Elan but I could see this is the kind of thing where we would put out thousands of dollars and hope that Elan would consider it "directly related" to the study.
The bottom line is here that we have to decide if it's a deal breaker, which it is not. I will continue to chant to myself that "there won't be any complications with the drug" and if there looks like there might be that they'll pull him out before it gets bad. God hasn't brought us this far to drop us now! Thanks everyone for listening to my paranoid rantings.
I wonder if Elan really would resist paying for care. They're not an insurance company, they develop drugs. If someone were to suffer a serious side effect during one of their trials AND they refused care, imagine the negative publicity! Elan would have a terrible time recruiting in the future. Trouble recruiting = trouble getting new drugs to market = major trouble for drug company. Plus people would start worrying that Elan drugs might not be safe in general.
If you have trouble getting into the bapineuzumab trial, maybe the GammaGard will be recruiting in your area. There are far fewer safety concerns, since the drug is already approved for other applications.
Joan, I'm so sorry to hear Sid is out of the study, especially, as someone else said, after everything you went through to get in. Now I'm more nervous as we approach the date for the second infusion. I hadn't even thought about what would happen in the case of a serious side effect. This is so darn hard!
Please try not to worry. Elan is being very cautious, and if there is even the slightest abnormality in the brain MRI (as in Sid's), they will pull your husband out of the study. And offer to follow him for the remainder of the study time with follow up blood work, brain MRI's, and cognitive testing.
I did a long comment this morning but was timed out.
Joan, Even though you and Sid were unable to stay in the study, I want to thank you for your efforts whcih help us all.
We have a screening appt for next week. It will be the Phase III, so 60% will have the agent and 40% placebo. I was concerned about the MRI screening so I called the AD center who is facilitating the study. The nurse did comment that one reason Elan was closely monitoring the MRI's was to determine whether people with pre-study problems like vascular dementia were inadvertantly admitted into the study.
My BIL who has AD has been in the study for a while and is now in the dosing study. They think in the prior phase that he got the placebo. He has received 3 infusions of the agent without any problems. He is in stage 6. We just went to TX to visit him. While we were there, his wife told us he read 3 numbers off a truck they saw while driving. She said he has not known what a number is for 3 years. Hopefully this means Bap is effective in attacking the amyloid. But there has not been a huge change in his symptoms. The neuropsychiatrist we have seen told us he thinks a drug like Bap will be more effective on those who aren't even exhibiting symptoms yet but are producing too much amyloid. This drug may reduce the overproduction. Once it has already built up, like it has for people like my BIL, the effects will be small. However, he thought this type of research is on the right track and is receiving the most attention and money. So hopefully, more effective drugs that unclog the amyloid will be coming down the pike.
I have been researching the BAP study since my husbands diagnosis. I prayed every day that he would get in. The obstacles we had to overcome were unbelievable. He was scheduled to get a pacemaker after his heart stopped last year in church (of all places). Thanks God after they shaved his chest before his surgery the cardiologist wanted to do one more test. It was discovered he had syncope and a pace maker wouldn't fix this problem. At the time I was distrait since pacemakers were listed as an exclusion for the phase II trial. When I lost hope our Sunday school teacher said “God hasn’t brought you this far to slam the door shut”. I still think of those words I have doubts. I hounded two centers monthly for almost a year until finally he was called in for the screening. There were additional problems that we had to overcome but he did finally get into the study.
One month after his first infusion he started remembering the date & the day of the week something he could not do in years. Three months later he is still able to do this. Several months ago the keypad to open our garage door died. My husband tried in vain to fix it to no avail. Last week he went out to run and forgot to take the keys to the house- imagine that. He called me and was upset at himself for getting locked out of the house while I was at work. This week on his own he drove to Home Depot and bought a new keypad. He installed it, called the 800 number, and with the help the operator had it working within an hour. He told the operator “ tell your friend this is so easy even someone with Alzheimer’s can do it”. DH still has his sense of humor!
My point is this my husband has had no problems so far. How long this will last I don’t know. We all realize AD is fatal disease. Regardless of our spouses having late or early onset our children have an increased risk of developing the disease. Anything we can do to help of scientist rid the world of AD would be a help.
Trish, That is wonderful your husband has made such improvement. This is truly amazing to me. Thanks for sharing, it has given me alot of hope. Even if there isn't a cure for our generation, I am definitely more hopeful for the next.
Trish, thanks so much for posting. That's just soooooooooo great to hear!
I'm not having any luck so far convincing the powers that be to let my husband into the Bap trial, but am hopeful I could get him into GammaGard or RAGE. Am setting up an appointment with his new neuro (who is the Principal Investigator on the RAGE trial) to discuss possibilities...
Sid did show improvement after the first infusion in 3 areas. He seemed more alert and less confused; he definitely was remembering more names and retaining that memory; and when reminded of a conversation we had the day before, he recalled it, whereas he had lost that ability months ago.
Considering this BAP is a drug that supposedly breaks up the amyloid plaque in the brain, I am wondering if what was broken up will remain so, even without another infusion. We are, of course, assuming that he received the real drug and not the placebo.
Thank you. I did call to see if I could get my wife into a clinical trial. They said that since she is on Aricept and Namenda, that she would not qualify and did not recommend taking her off the meds.
Guy, many trials WILL accept patients who are on conventional AD meds. Most trials will accept patients 55 or older. You just have to look at the exclusion criteria for a particular drug AND for the particular trial for that drug. Sometimes, they actually require that a patient be on one of the FDA-approved drugs, because they want to see what a combination of the new drug and the approved drug might do.
For example, I think the bapineuzumab trials accept patients on both cholinesterase inhibitors (aricept, exelon, or razadyne) and namenda. My husband just finished a trial on a new cholinesterase inhibitor, and I'm trying to get the bap people to agree that it should be included with the approved drugs... so far unsuccessfully, but who knows if they'll finally cave in. Also, you may be in a location where more than one organization is running a trial, and the different organizations may interpret the rules differently. I found there's another place running a bap trial here, and may see if I can sweet-talk them. Doesn't hurt to ask.
Guy, I'm afraid I'm not much help there. My husband was very agreeable, I didn't have to do much other than just ask him. I told him I wanted to do whatever we could to fight this disease, and he's trusted me to pick out a good trial. (He did announce he wasn't about to do the trial that involved lumbar puncture tests periodically, though -- he'd had a bad experience with one of those a long time ago. I didn't think that drug looked all that promising, anyway.)
He's been great about going in for the checkups etc -- he really likes the PA who does the testing. She is just a hoot, used to be an officer in the Air Force, definite "command presence." He likes that, he was an officer in the Navy, so they understand each other. And she does things like work with a church that set up a school in a tiny, godforsaken town in Africa, and she went there for a month to help out. (What really tickled me was that she was a bit nervous about traveling over there alone. She had seemed so very self-sufficient and has done so much traveling with the Air Force, I never would have expected that.)
Bad news re BAP trial participation for us also. Went yesterday for the second infusion which I thought was a sure thing since we hadn't been notified following the second MRI. In this case my husband was not bumped because of a change in the second MRI, as in Sid's case. We were told that there have been three cases nationwide of bleeding in the brain in phase III. Elan went back and did a more in-depth evaluation of the initial MRIs. They found some micro-hemorrhages in my husband's case and are withdrawing him from the study. They will continue to follow him for the remainder of the study time with follow up blood work, brain MRI's, and cognitive testing. I had not noticed any improvement so perhaps he was on placebo. Nevertheless, I am very sad. It doesn't seem to have sunk in with him, though. Yesterday evening he said "We had a decent day today."
Dee, I am sorry your husband has been dropped from the study. We, also, went for a second infusion, yesterday. It went without any problems. However, I think DH must be on the placebo, since there has been no improvement. In fact, last night he asked me if we were going for the infusion today. It was kind of exhausting for me. We had to go on Wednesday for him to have memory testing and my short interview. That was 2 hours. Yesterday, we were there for 6 hours. A good factor is he likes all the attention, but he hates the MRI's. I have noticed a lot of things don't sink in with DH. Maryd
I too am sorry about your bad news, Dee. Now I am hoping that they will also do more in depth studies of my husband's MRI's. We went for the second infusion yesterday and this time we were there only four hours. Like your DH, maryd, mine likes all the attention. We had the memory testing 2 days before and when he came out he said it is a waste of their time as he could barely answer anything. Yesterday he forgot that we were going for the infusion even though we had talked about it the night before. However, this morning when he knew I was going out he scraped the ice off my car without any prompting. I know this is a small thing but when so little initiative is ever shown it seemed a big deal.
Sorry to hear your news, but I am SO GLAD this discussion is up on the board. It is informative for everyone. Our neurologist did say that the abnormality in Sid's MRI could have been the result of a brain bleed, and that is what Elan is watching for.
Inge - Yes, Elan is reviewing all the MRI's of everyone in the study.
Problems cropping up in Europe with the bapineuzumab trial. The European trial had been temporarily halted to allow time to check out potential health problems. Below are the links. (The video has a lot more info than the article):
NEW YORK -(Dow Jones)- Wyeth (WYE) is seeing enrollment delays in the European Phase III trial of key pipeline drug bapineuzumab, in development with Elan Corp. (ELN) for treating Alzheimer's disease, as participating countries request additional information.
A mid-stage study released over the summer showed the drug missed its main measure of effectiveness but showed benefits in a subgroup of Alzheimer's patients.
In the wake of that study, Wyeth said during a Wednesday conference call that countries have asked to review its data, as well as the Phase III protocols, amendments and current safety data.
As a consequence, many countries asked Wyeth that enrollment not begin until they completed that review, and the countries that already started enrollment asked Wyeth to halt the process until review is finished.
"We really are a little behind where we would like to be in getting the full European program up and running," said Joseph Mahady, senior vice president,
Wyeth said those meetings and submissions are ongoing, but that it remains "fully committed" to the trials. It noted in the call that the time issues are "very significant" and "resolution is getting high priority."
At the bottom of this page is a link where you can sign up for email alerts for the latest news on bapineuzumab:
Well, I took my husband to Georgetown a few weeks ago for his first on-site screening appt. Everything was going well until they asked him if he had given blood in the last 90 days. Well, in fact he had since he give regularly...big mistake. So we were told we would have to wait now until Nov. 4 to have him rescreened and then enter the study.....this is the study we have been "entering" since last July if you recall me earlier posts. Ok, so I tell him he has to wait a few more weeks and no tears this time he just simply adjusted to the new date and went about his disappointed way.
Now I get a phone call form GU that their MRI machine is going down for maintenance or something and that maybe we should just reschedule the "rescreen" for after Thanksgiving so that he can then have his MRI within the required 42 days. THis would be instead of doing the rescreen on the 4th and risking that the MRI won't be fixed in time. (do they really only have one MRI unit on the entire campus of Georgetown University Hospital??????) But Ok, I can live with that but no, they won't put him off. As I told the GU staff, If I tell him he's put off one more time he may not get out of bed for a week. I said I would bring him in on the 4th and they could do whatever they wanted and he won't know the difference. And then if the MRI machine isn't working by Thanksgiving they can bring him in to do something else. As long as he feels like he's participating somehow in his own treatment he's ok, otherwise he's going to curl up in a ball.
And now I read these stories about the studies in the EU being put on hold. Is that what's next for us here in the states since the US-FDA is generally more strict than the EU on testing???? I'm beginning to think this is my Higher Power's way of keeping this drug away from my husband no matter how tenacious I am about getting him into a study. I know I tend to be a bit of a conspiracy theorist but you gotta admit this is going sort over the top huh? Will he ever get into this study? Now I'm thinking another study might come up first back at Hopkins. I'll take anything at this point.
Sunshyne, thanks for the link & update. My DH is scheduled for his MRI screening for the Bap study Monday. His brother has had 3 infusions with no problems thus far. I will call my SIL this weekend to see how things are going.