brookhvn1, how incredibly frustrating and disappointing for you! Maybe the GammaGard trial will be run in your neighborhood, and you could go after that one. It appears that there are fewer safety issues. In theory, it's been started, but it's not recruiting yet, and it isn't up on clinicaltrial.gov yet, either.
Baxter initiates Phase III Alzheimer's trial 23rd September 2008
Baxter Healthcare has initiated a Phase III clinical trial following FDA review of its investigational new drug application to evaluate Gammagard Liquid, marketed as Kiovig in EU, for the treatment of mild-to-moderate Alzheimer's disease.
This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for Gammagard Liquid as a potential treatment for the disease.
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 US leading academic centers have been identified and will begin clinical trial enrollment within the next several weeks.
Efficacy will be assessed by two primary endpoints: Cognitive outcomes using the Alzheimer's disease assessment scale - cognitive subscale score, and global clinical outcome as assessed by the Alzheimer's disease cooperative study - clinical global impression of change rating.
Secondary endpoints to be assessed at 18 months include behavioral, functional and quality of life outcome measures. Other secondary endpoints will include several plasma, cerebrospinal fluid, and imaging biomarkers to assess disease progression and response to therapy.
The trial is sponsored by Baxter and partially funded by the National Institutes of Health through the Alzheimer's disease cooperative study.
...or have you checked into the RAGE trial? (Receptor for Advanced Glycation Endproduct inhibitor.) That looks very promising, and it's recruiting in the DC area. I'm going to discuss the pro's and con's of both trials with the Principal Investigator of the RAGE trial in December -- my husband has an appointment with him then -- or I may just decide to hassle some friends at the AD Research Center if I can't contain myself that long.
The MRI machine situation was explained to us by the trial nurse- the drug company makes the decision as to what facility and which machine, and they will not budge on it. That is probably why you've had to wait if the "approved" machine needs repair, and it probably needs to be checked out by the drug company before it can be used again.
Thanks for you input gang. I know in my head that all of this makes sense and if it weren't for these very strict rules none of us could count on predictable results. However, when I go through a week like this one where my husband couldn't be left alone with my eight year old to carve a holoween pumpkin and when called on by her friends dad last night to give him home address he couldn't remember and had to hand the phone to me it just makes me want to scream and go and stage a sit-in protest somewhere...........but where? Thanks for letting me vent.
My almost new computer conked out in the middle of the youtube video. I hope that's not a bad omen! So far we have had no indications from our doctor that there is a problem with the Elan study but it certainly is a time commitment and we have to travel an hour each time for the MRI. We have a good hospital with MRI machines only a few minutes from our home but apparently they will not get involved in drug trials. So far so good but we have been told to wait at least until the 3rd infusion if we are going to see positive results. I have to be thankful that we didn't have the hassles others have experienced in getting into this study. One thing our doctor mentioned is that Vivimind, formerly studied as Alzhemed is now available as a natural product over the counter. I believe that this drug helped my husband as he declined markedly once the trial terminated in November 2007 so that might be something we would reconsider if the current trial fails.
Update from MD: We to to our appt at Georgetown and as promised they had us in and out the door in under an hour. They only had to redo part of the initial visit...yeh! He's now officially in the 301 group and has an appt for his first MRI next week and then he'll have the lumbar puncture after that....
I feel like we are finally getting closer to actually having a drug (or at least a placebo) put into this guy. And not a moment too soon.
Please go to the home page - www.thealzheimerspouse.com - and read today's blog (11/11/08) about our neurology apt. yesterday. There is some information in there that may help you in making decisions about trials.
Did your doctor indicate how long it would take for the BAP to dissipate? We also had the problem of being dropped from the study because of previous micro-hemorhages so perhaps it doesn't matter if it precludes participation in other trials.
He mentioned 13 weeks, but wasn't too firm on it. I didn't ask, but I wonder if any of those previous micro-hemorrhages had anything to do with developing AD. In other words, could the developing plaques and tangles have caused a bleed? I'll try to remember to ask next time.
Sunshyne wrote this on another thread - it is information about drug trials, so I am putting it here.
The primary thread on this topic is "Drug trials / drug vaccines". Brought it to the top for you.
There are also a bunch of blogs by Joan ... they struggled to get Sid into a Bap trial, and then he ran into a problem and was dropped. So sad. But most of that is briefly summarized on the thread.
I was very interested in getting my husband into that trial, but they won't take him because he's on huperzine A. Despite the fact they'll take people on any of the other cholinesterase inhibitors, they consider this one to be investigational, so no dice. (He was in the Phase III clinical trial on huperzine A, for 2.5 years. He is continuing to take it now that the trial is over.)
Since then, I began to be ever so slightly concerned about the potential problem for bleeding in the brain to develop. There is another trial on another immuno-type drug, GammaGard, which has either just started or is just about to start. It looks as if there might be fewer safety issues, since GammaGard is already FDA approved for other disorders. You might want to look into that.
Then there's also the RAGE inhibitor trial (receptor for advanced glycation endproducts, if I recall correctly), which looks very promising, and started recruiting recently.
I'm hauling my husband in to see his neuro tomorrow, to discuss those. His neuro is the Principal Investigator on the RAGE trial, and possibly will be on GammaGard, too.
Thanks for your direction on this. It looks like others are in the BAP study as well. The study we are looking at is AAB-001; ELN115727. Still waiting to hear if he has the AD gene or not.
Wishing everyone the best possible with whatever study you are in.
Update from MD. It's been almost 2 weeks since DH's first infusion of BAP at Georgetown.....Nothing yet but he's hopeful. He's being a real trooper through all this. He had the lumbar puncture with no problems and the infusion was no big deal. He even said he could go to the next appointment by himself if I just dropped him off. COOL. Don't know if I'll go for that but if I do my office is ten minutes away. I think I'll just go and bring the newspaper like last time.
The infusion came just a the right time. It was two days after the OT at the local hospital made him surrender his drivers licence. That was the worst I have ever seen him. I knew it would be bad but I have never seen that emotion come out of one person. I had to leave him alone the next morning for a few hours while I went to a meeting and I seriously though I would have to have somebody go by on suicide watch. He was ok though. IN fact, when I got home to drive him to his first day on the metro train, he made a joke about feeling like this was the first day of school and he should be wearing a yellow school bus with his name and address on a string around his neck. He was also taking the car keys off his key ring and looking for a place to put them since he no longer needed them. I knew he would be ok. PS: The solo trip on the metro wasn't so hot for him so we have been riding to work together since.
So the first bunch of activity in the study is over and we go back for an MRI on Jan 22 and another infusion in 11 weeks. Cross your fingers for nothing on the MRI. He feels soooo much better just being part of the process even if there is no indication it's doing anything yet.
What great news... thanks for the update, brookhvn1.
We had a brief flare of hope that we might get into the Elan trial -- my husband's new neuro felt that the dose of huperzine A he is taking should not disqualify him. Shot down in seconds when I tried to wheedle our way in. The nice woman running the trial here tried to talk Elan into accepting us twice, but no luck. She says there's a gamma-secretase inhibitor trial scheduled to start in June, and will forward our info to the person running that.
So ... I need to think about whether I want the bapineuzumab trial badly enough to switch to a conventional cholinesterase inhibitor. Meantime, I'm going to see what new info may be available for the RAGE inhibitor since the last time I did a search, and also see if the gamma-secretase inhibitor is the same one I looked up before. That one didn't impress me very much, but there are some newer INDs in the same category that look more promising.
I noticed a few references to the RAGE inhibitor trial recently, so thought I'd post a brief bit of related info. We began participating in this trial (PF-04494700) in Sept (husband diagnosed with AD about 1.5 yrs ago at age 52). The required visit schedule has worked out well with our relatively remote living situation (several appts within a few weeks to a month of each other initially, but past that visits are only about every 3 months). There have been no apparent side-effects thus far (but then maybe he's taking placebo...; only other meds taken currently are Aricept and Namenda).
Maggie, you mentioned no side effects. Have you seen any improvements? It's frustrating not to know if he's getting the real thing or placebo, isn't it?
Thanks bluedaze. Dazed- can't say that I've noticed any significant improvements, but then I’ve also not noticed any significant consistent declines (memory testing at the appts is conducted without me present, so I don't have any impressions based on his performance at those). It's frustrating not knowing whether he's taking the active drug, but we're still satisfied that at least there's the possibility (2 out of 3 chance of taking active drug in this study). Also, my husband has been terribly frustrated with being unable to work anymore (along with other changes), and participating in the study seems to satisfy at least a little his desire to continue to "contribute" in some way.
Just want to let you know that Medivation will be announcing some new Dimebon trial sites soon. The number to call is 1-877-888-6386. Probably best to call mid-end of February.
I was told they would be starting new trials that will allow "background" medications, which I'm presuming is aricept, razadyne, etc. This is good news, as most don't want to have to discontinue these meds to be eligible for these trials.
Does anyone know anything about the proposed trials some of us were inquiring about a few months ago? I can't remember what it was but they called me and were supposed to get in touch with me later but that was the last I heard about it. Supposedly the Alzheimers Assoc. was giving them some money for the trials. There was a man from this website who had also talked to them and I don't remember if it was Marsh or who?
Can't remember the scientist's name off the top of my head, lmohr, but I do remember he sent details to Guy, who sent them to me. And I remember that I continued to be very unimpressed ... as I'd thought, the clinical evidence he'd mentioned was for individual constituents, not for his mixture. Most of what he cited was done in animal models.
And then I got to the details of his forumula, and noticed that he's got Vitamin E in it, for example. Well, yes, Vitamin E is being studied for treating AD. But the level in his formulation is far lower than the standard level a normal person would take, let alone the much higher levels that are undergoing trials for treating AD.
Sigh. I suppose it would be easy to find his name, just by looking for Guy's email... here 'tis: Thomas B. Shea, Ph.D.
My wife went thru a battery of test to get into an new study with vaccine. She passed everything except the spinal tap. This elderly doctor was doing the proceedure and I think he was too proud to ask for help. He tried 3 times. I was in the room hold my wife when he hit her nerve and her legs start shaking wildly as I was trying to hold them down. She was is so much pain, I asked him to stop. I did some research afterward and felt there were some other positions he should have tried. The doctor claimed she had too much arthritis on her spine.
moorsb, your wife's problem with a spinal tap reminds me of an experience I had in medical school. The intern was trying to do a spinal tap on a patient, and failed. The resident then tried and failed. Finally the chief resident tried and failed. They were going out to get more help, so I, as a lowly medical student, decided to try. I hit it on the first try. I had been watching where they all went, and just went in a different direction.
when the labs miss my veins for blood i almost pass out it hurts they move that needle in there trying to get the vein! i cant imagine anyone poking around for a spinal tap!! gosh that would be unbearable. i wouldnt let them do one on my DH when they were trying to dx DH. it turned out to be vascular anyway. divvi
I'm a 13 gallon blood Donner. Because of my surgery they can only use my left arm. When I am a tough stick they complain-what do they think it feels like on the other end of their garden hose. Because our ship stopped in the Dominican Republic I can't donate for a year because of the threat of malaria.
My veins roll out of the way most of the time. I hate it when they jiggle the needle trying to get it into the vein. I usually end up with BIG bruises that last a week or more. I have had one on my left arm starting just above the wrist almost up to the bend of my elbow that was from an IV in the hospital.....it is almost gone over a week later.
Just found out Dimebon will be recruiting here for its next clinical trial. Oh, boy, am I interested in that!!! It is my understanding that patients will be allowed to be on cholinesterase inhibitors and/or namenda.
Details about locations have not yet been posted. I was pestering one of the Bap test centers, to see if they'd be any more cooperative than the one which turned us down (hope springs eternal), and they told me they'd just found out they'll be participating in the Dimebon trial today.
The Dimebon trial at UofM requires that the patient is not on any AD drugs, ie namanda, aricept etc. Hopefully they changed the requirements. I was too afraid to take my DH off all AD drugs in fear of a steep decline.
Yes, I believe they have changed the requirements and now allow Aricept and Namenda. Anyone in the Southern Florida area - Premiere Research of West Palm Beach is recruiting for the Dimebon trial. At least they were. I don't think they're full yet.
The drug companies set the criteria, and after eliminating those with diabetes and other complicating diseases, they generally go by the MMSE. I believe you need a score of at least 16 to be eligible, or somewhere close to that. Which probably excludes those in the later stages.
Hildann, this is a new Dimebon trial, and they haven't started recruiting yet. They haven't even announced the trial sites yet. Patients can be on cholinesterase inhibitors and/or namenda. See:
http://clinicaltrial.gov/ct2/show/NCT00838110
There is, however, a link near the bottom of the page you can click on, to request information on a study center near you.
There is another Dimebon trial that hasn't started recruiting yet, that requires the patients be on Aricept:
http://clinicaltrial.gov/ct2/show/NCT00829374
Bluedaze, the eligibility criteria depend on the specific trial. Most drugs are tested on early- to mid-stage patients because it's usually easier to demonstrate efficacy. Aricept was originally approved for early-stage, but has now gone through trials for all "three" stages and is approved for all.
Namenda, however, went against the grain, and was the first AD med approved for treating moderate to severe. Interestingly, when they went back and started testing early-stage patients, it didn't do as well.
One of the Dimebon trials above was accepting patients with MMSE 12-26 inclusive (I wasn't paying much attention to that part of the web page).
So I looked for clinical trials for patients with severe AD. They do have some (MMSE scores 1 - 12) but they all involve one of the current AD meds -- namenda for treating behavioral problems, for example.
Thanks, Sunshyne. I stood by and watched Bill for quite a while today just to see how he was functioning. His color was great. Feeding himself lunch. I could not get him to realize I was there. Nothing would distract him from eating. Another woman comes in daily to feed her husband. I call him big bird. He is in a special Gerri chair because he is so tall. Has a fantastic smile. Anyow-there is no filling the man up. He eats his meal then opens his mouth like a huge baby bird for more. They don't know that they have eaten-talk about short term memory loss.
Good morning all. I have gotten my husband in a trial with Elan - the trial is Phase II - it is pills - ELND0005. He started pills in October, 2008 - 18 months trial. I think he is getting a little worse - seems to be up more during the night - disoriented when he gets up in the morning. Blood pressure seems to be affected (low). Not sure if he is entering next phase of Alzheimer's or if the pills are affecting him. Sometimes I think I should just stop the pills but then I think, what if they work. I'm so tired.
We have a friend who is in a trial with pills. No name, just a number, but the number you wrote doesn't ring a bell. He was doing quite well on the pills, then he had to stop them for a month. That is the way the trial works. He will start them again soon. He went down hill while off of them.
I'll find out what the number is. Most of the people here are on the IV Infusion Elan BAP III trial.
Researchers at the University of Toronto have found scyllo-inositol can block the accumulation of soluble amyloid-beta (Aβ) plaques in the brains of transgenic mice. It reversed memory deficits in the mice, and reduced the amount of Aβ plaque in their brains.
We are doing the Elan trial in Denver, CO. We go to the dr. every couple of months - some months they will do an IV of the drug or placebo (wish we knew which!! I hate that...) and the other months my DH will go for an MRI or cognitive testing/questions. I also have to answer questions on some of the visits. Haven't seen any noticeable change yet - he started it in October. He did get to keep taking his Namenda and Exelon tho, which was important to me!
Good luck to you & your husband. My husband is also in the Elan BAP trial. So far no set backs. At this point I'm praying for stabalization or a slower decline. We go for another infusion this month.
My husband has been in the Elan study for 9 months. He is due for an MRI this week. I had to reschedule Monday due to bad weather. Since then he has been so confused and anxious. First he thought we had gone and no one was there. Now we are scheduled for tomorrow and he doesn't want to go. I called the test coordinator to talk to him about it and that seemed to help. He told me he was too old. We are the same age, 70. I told him I was his age and I had to do everything, cooking cleaning, paying bills, taking care of him. That did not seem to get through. The infusions of the drug do not seem to have helped him at all, so if he quits the study it won't really matter. I feel bad because I think he is giving up. We sill see what happens tomorrow.
As most everyone is aware, Sid was dropped from the Elan BAP III trial after one infusion due to a more advanced MRI, which detected previous brain bleeds. We did, however, opt to be followed by Elan just as if he were in the trial, with cognitive testing, blood work, and MRI's. The strict scheduling got to be too much - it's a 100 mile round trip. We felt we were going for nothing except giving up a lot of time. I was especially annoyed because Elan refused to release any of the reports to me. Confidential for their records.
In any case, yesterday we asked the doctor if Sid could get into another trial. He said that most drug companies want to wait TWO YEARS to make sure the previous drug trial drug is out of your system before they allow you into another one. But he will try his best to find something for Sid.
We both honestly felt that the one infusion he received was the real drug, and that it did help him. He received it in August, and most of its positive effects have worn off now.
We had a bad day yesterday with DH asking me about his MRI, every 8 minutes. I timed it. He would ask, where do we have to go tomorrow, what are they going to do, how long will I be in the MRI machine, is it a tube, what should I wear, I am not sure I can go, I am too old. We were there at 8:15, he had the MRI. I was in the room with him, touching his leg the whole time. It took less that 30 minutes, he did fine. He even said it wasn't so hard, it was a piece of cake. He had some cognitive testing. I saw the doctor alone for a few minutes and told him about the anxiety. He said next time, don't tell him he going to have an MRI. Let him find out when he gets here. blame it on the doctor. I will try that.
I agree with the doctor- wait until he gets there before you tell him. You are more than halfway through the study and if you continue the odds are good that your husband will be put on the open label. Which means that he will get the real drug and hopefully it will work for him.