This is my first response to the message board but I read them everyday. I got my 55 yr old husband into a clinical study for bapineuzumab. The first iv was given and the nurse did not get the vein very well. My husbands hand and arm swelled. I was told that some of the medication went into the tissue but that was okay since it would be absorbed anyway. It seems that this would affect the absorption rate for the study but I dont want to complain since I don't want to get thrown out of the study. These are given every 13 weeks so we have a long time to wait for the next one if this one didn't get to the brain. I will report if I notice any improvement. Hoping this is the drug and not the placebo.

Looking for a miracle......

Hi, lesa. We'll look forward to your reports on how your husband is doing. How long will you be in the double-blind part of the study? Will there be an open-label phase?

Jab:

They have approved the open label for 1000 participants starting at the end of this year. The exclusion for the OLE is an MMSE below 10. The double blinded portion is 18 months.

My husband has had his last infusion in phase III and I was under the impression that he would go into the open label at the beginning of the year. I was never told that there might be an exclusion due to the MMSE score and I'm really worried now.
I will pose that question to the research assistant.

He will get 6 infusions 13 weeks apart but they did not mention the open label study. I will also ask on next visit. It has been a week now since the first one and there hasnt been any difference. Has anyone in this study seen any improvements?

My husband certainly did not get better, in fact in the last 6 months the decline has been dramatic.
The research assistant did tell me that some people in the study improved so there may still be hope for others.

Traude, Im so sorry to hear that. Maybe he got the placebo. It is so long between infusions that I dont know if we have that long to wait. I cant get my husband to take the coconut oil either. I have tried mixing it in everything but he takes one bite and says it tastes awful. What do we do, just give up or keep trying everything.

Lesa, you might try MCT oil. It is pretty much tasteless, and you can mix it with lots of things. It has a lot more of the "active ingredient" than coconut oil, so start off slowly.

quote:

Originally posted by lesa:
I have tried mixing it in everything but he takes one bite and says it tastes awful. What do we do, just give up or keep trying everything.

My wife tolerates Axona quite well. I don't give her any other MCT's anymore. Too many digestive problems. Axona is expensive (but so is everything else once you reach the Medicare donut hole).

I was asked if I wanted in a study I said NO,but heck no......I don't trust that type thing,besides when i was put on medication I wanted the real deal......

Clincal studies would not be my first choice but regular doctors offer nothing. They just wanted to send us home to die with absolutely no hope or new drugs to try. My son could be facing this if a cure isnt found so we are doing this for him too. I would rather sign a waiver and try anything that is out there but that doesnt seem to be an option and you cant find these drugs anywhere to buy yet. We have been to many doctors and none of them even ask us to be in a study, I had to find one on my own.

tkb, you mentioned that those with an MMSE score less than 10 would be excluded from the open label for bapineuzumab. I wonder where you got that information. I checked other websites and as I understand it everyone who was in the study is eligible. It would be highly unfair to exclude those people and for the drug company to pick and chose whom to let in seems unethical.
As far as I know we will be in the open label in the new year.

Traude, why don't you ask the person running your particular study -- the person with whom you regularly interface? They would be the ones most likely to know what the "ground rules" are for the open-label stage in your study. I'd call right away, not sit and stew and wonder.

tkb may be in a different study than the one you're in. There are at least nine Bap trials ongoing right now.

JAB, I have done so and was assured that all those who participated in Phase lll will be eligible for the open label.

That's good to hear!!! Best of luck, let us know how things go for you!