Paula,

Does your neurologist completely negate the vaccine that will be in clinical trial next year in Austria? From the AFFIRIS news release:

Referring to the successful completion of the preclinical development phase, Dr Walter Schmidt, director and co-founder of AFFiRiS AG stated: "We have had PD01 evaluated in various preclinical systems. All the tests have shown that this vaccine works against alpha-syn. In addition to histological and biochemical analyses, we have even been able to observe behavioural improvements as a result of our vaccination. We are now starting preparations for the clinical trial of PD01 which will supplement our current clinical programmes".

The vaccine PD01 takes advantage of the fact that accumulations and the associated deposition of alpha-syn in the brain are partly responsible for the progression of Parkinson's disease. A reduction in the alpha-syn concentration in the brain should therefore have a positive effect on the clinical progression of Parkinson's. It is precisely here where PD 01 acts, as the vaccine triggers an effective immune response to the harmful alpha-syn, as a result of which the body's own immune system reduces the alpha-syn. AFFiRiS is now able to announce the successful outcome of the preclinical phase confirming the effectiveness of this principle.


I am hopeful that this will at least halt progression or slow it way down..Perhaps this with GDNF will be the next best thing to a cure...

Speaking of international differences in trial design...can one who is a non-citizen participate in a trial if they pay their own expenses?


-Laura

Paula,
I am starting to think people are like the bee colonies - they are collapsing because of EVERYTHING......

You briefly mentioned duodopa, I have heard great reports of it and think that it is a hugely important option, given that very little is emerging in the way of new treatments.

Will post when I get more on it....

Lindy

Hi Paula, Why do I feel the reasoning of your neurologist is blackmail? If one cannot determine what is placebo effect; if the biolarkers for determining what works and what doesn't are non objective (and thus nonexistent); if the placebo effect is so strong in PWP how would researchers ever figure out if the experimental effect is working vs the placebo? there are NO OBJECTIVE measurements. How does sham surgery help with this? If the placebo effect from the surgery as well as the experimental arm results in increased benefit, how will the researchers determine if the experimental therapy works? they do not measure via brain scans; there are no laboratory measurements. Until there are objective measurements/lab measurements which show definite benefit from therapy, there is NO WAY to truly determine if the therapy is working. So how exactly does it help to have an arm that is sham surgery? Why are European researchers able to conduct neuro research without the use of sham surgery? I wonder, does Israel allow sham surgeries for experimental trials?

I think we should petition President Obama to notify the NIH that their budget will be cut off until this barely disguised threat is investigated.

Here's a thought, how about the control group being those individuals who do not receive the therapy/procedure? what a novel idea. and if positive results of the experimental therapy is really due to placebo effect, then....how would having sham surgery prove that otherwise anyway?

what, all research into cures for PWP will stop unless there is better participation from PWP in sham surgery experiments? A Pox on their houses, as my mother would say. (and I know before punching "submit" i will be sorry for this, but will do it anyway) madelyn

Bob - continuim movement..something else to look up. If it's working, then I'm glad you found it.

Laura - I didn't think about the vaccine. Thanks for reminding me of that. It makes me uncomfortable to mess with alpha synuclein without knowing what it does or what it's for tho. Cart before the horse?

Madelyn - Know what you mean by "blackmail". Reminds me of the statement I once heard, "I'd do this procedure on my mother."

Perry Cohen has some interesting thoughts about the statistics and placebo. After talking with an advocate from the UK and a physician, my impression was that sham surgeries do happen in Europe but not often and they are much less comfortable with the whole idea. It was mentioned that perhaps they do when there are American sponsors like with GDNF. It's not common though.

lindy knew that of course! I have heard some good things about duodopa too from the Alabama folks.

Measuring progress is another area of need - peg talks about that too.

Actually we are learning that most people have no idea that it is even done at all anywhere.

Just thought I'd weigh in on the research in general ......

Seems as if we are putting the cart before the horse, as Paula stated regarding the alpha syn vaccine, when it comes to all trials and treatments for PD. Until we can identify and track biomarkers, which will also help define and better understand the disease itself, how can any trial that presumes to modify, stop, or reverse progression be supported?

Right now, any trial surgical procedure for PD is a sham - regardless of which group you fall into, control or other. There still are no objective measurements or a way to determine success beyond symptom control.

I continue to find myself in the group who says, "no DBS for me unless absolutely, positively, necessary" (and I don't know how to even measure that point of no return).

The MJFF biomarkers study and others who are also collecting this kind of data are crucial. We will have to wait several more years for the results, but I hope new treatments based on this data collection will come more quickly and be more accurately targeted. This may lessen the need for sham treatment of any kind.

bumping this up and extending the deadline to ?? Linda H. can fill in that blank. We are getting some excellent comments

Please consider adding your voice. This survey will be part of a presentation to the NIH, and inclues top doctors like Mark Stacy, Warren Olanow, Tony Lang...the list. They had perry last but he got it changed to first presentation on the second morning.

thanks.
paula

sorry - i'm jusst seeing this today Thanks to e veryone who responded to the survey. We can extend the deadline to Wednesday. we need to leave enough time to analyze it and write a report. The survey questions are posted at the beginning of this thread. Thanks again.Linda