The Stanford Parkinson's Disease Plasma Study (SPDP)
 

The Stanford Parkinson's Disease Plasma Study (SPDP)

The Stanford Parkinson's Disease Plasma Study - Full Text View - ClinicalTrials.gov

Hi Badboy,

With 99% of alpha synuclein contained in the red blood cells that leaves 1% contained in the plasma. Correspondingly, since this study involves only transplanted plasma, I doubt if this study will show significant changes to PD symptoms but I could be wrong. I'm glad they're doing this study though as the young blood may invigorate cells in other ways which might improve symptoms!

Thanks for posting this Badboy. I just emailed them...I live about 20 minutes from Stanford and this study sounds interesting.

I see that the age cut off is 50 though - I'm 46. Not sure if they will take any exceptions but we'll see!

anagirl, Let me know what they say regarding age cutoff and the start date for the study. Also, if the phase 1 people will get a crack at phase 2.

I definitely will!

Inclusion
 

I have been accepted for the trial and will begin in January. i was told that if the outcomes merit it, our infusions will be extended for another 4 weeks with travel expenses paid. They are not paid for the initial trial. I am 71.

Anagirl, would you like to meet while I'm there?

I would love to meet with you, Nan! I will private message you my phone number and email address.

I still have not heard back from Stanford regarding the study. I guess I just missed it by 3 and half years.

Here is a report on the Stanford plasma study so far. I went down to San Jose on 8 January and returned on the 10th. The ninth and 10th were all the opening days of the study. I am patient number one. They are looking for 18. I am told that age is not as important as other issues, so if you are interested, please inquire.

The first day I did all of the testing on my medication. The testing was both kinesthic and cognitive, including all the usual UPDRS, MOCA, walking up and down pathways with sensors attached all over, etc., nothing difficult at all, pretty familiar stuff.

The next day was off medication and that was a whole other story. I finally realized how to describe being off medication. It's like that Chinese finger puzzle where you stick your fingers in and pull and the harder you pull, the more it contracts and the more it hurts. This is like having your whole body in the Chinese puzzle for about two hours. I have never been off of medication for an extended period of time, a new experience for me. That said, it was nothing that I couldn't tolerate and I could go ahead and do all the tasks they were asking me to do without a whole lot of difficulty.

I go back to Stanford again on January 25 and 26th for the first two transfusions of blood plasma. I am certainly curious to see if anything happens because of it. We are in very new territory here but the people I'm working with are all first rate and I feel confident I am in excellent hands.

I want to encourage everyone who can possibly participate to sign up for this research Trial. At least call and find out what the parameters are and do your best to get in. If this works, it could be life-changing for many of us. As with all research, it is fraught with unknowns. There are certainly no guarantees that it will work but if you participate you are moving the ball down the road and helping all of us. The pain is real, but at least it is short.

That's awesome Nan. If I was closer to Stanford I'd participate. Please let us know how it goes! Tim

Trial underway for Alz.
 

Does anyone know how the trial they are already doing for Alz. is going? From the clinicaltrial.gov link for this:

A study that is ongoing at Stanford, in the department of Neurology and Neurological Sciences, is testing whether infusions of young plasma can ameliorate the cognitive impairment in patients with Alzheimer's disease (ClinicalTrials.gov identifier NCT02256306).

This isn't actually an answer Lurking, but the Parkinson's trial is based on the results they are getting in the Alzheimer's trial.

Tomorrow I fly to Palo Alto to have my first two plasma transfusions, the first given to a PD patient in the world I’m told. I don’t know how long it may take to see if there is any response to the plasma. The results in mice and people with Alzheimer’s has been positive. The next 6 transfusions will be given two per week, then more tests and probably more tests. I feel a little jittery.

The first transfusion is history. I feel much the same as I did before, but I'm certain there must be cumulative effects for any differences to show. I'll be tested March 14-15 and that will likely give us some verifiable information. I feel a bit emotional about the potential ramifications of this trial. But cautious optimism is the word of the day.

Over 50 people have contacted Stanford about participation in the trial. It will take a while for them to get to every person. If you are one of those interested, please contact Amaris again and note your connection with me. Of course she cannot share your names with me, but she would like to know if there is a connection. If you wish.

Thanks to everyone for your tremendous support.

I finished my second transfusion at Stanford yesterday and came home last night. I'm making a careful record of changes that I notice in myself, but we know that the real test will be when I am examined by the doctors at Stanford after all eight transfusions are finished. That will be in late February and my final exam will be in mid-March. I realize that there is a strong possibility of the placebo effect going on here, because I so very much want this to work. That said, the things that I notice the most are the lack of weariness and I have almost no off time prior to taking my medicine, which is a real treat. My very slight dyskinesia has pretty much disappeared and I noticed when I got up in the night that my balance was perfect. I am so curious as to whether these things continue or not. There is no nausea, a welcome relief. I just finished my hour bike ride and I actually went beyond the hour. I moved the bike into the next highest gear, making it harder to pedal, but had no trouble keeping up my pace at the 80- to 90 RPM for the hour.

ted talk stanford plasma study Check this out. The talk was given in 2015 but it's what this is about.

A couple of days ago I opened a jar of basil in my cupboard, and I could smell it! This is the first time I've smelled anything for years unless it had an overwhelming odor. I stood in front of my spice cabinet opening jar after jar sniffing with my nose and wiping tears from my eyes. Every day has its random surprises. I just arrived in Palo Alto for transfusions three and four. I wonder what's next!

Third transfusion today..

We had wine with dinner tonight and I could barely bring myself to drink it. I just sat there smelling it. It has probably been 20-25 years since I could savor the bouquet of wine. I nearly wept.

spice tears
 

Nan,

You have climbed mountains.
You have ridden miles - across Iowa - 80 rpm in one place.
You walked across the stage Sunday,
not bending to Parkinson's
and told us of plasma.
You share the spices that bring tears, the bouquet of wine
after so many years.
A gentle smile, a determination to press forward
and help us remember
we are all in this together.

Thank you,
Doug

Nan,
I had a phone interview. Seeing your smile as you walked across the stage at Sunday's conference in Tacoma prompted my contacting Stanford. Did the phone interview yesterday. Now waiting.
Thanks for sharing - especially the spice tears.
Doug

We're so excited for you Nan and hope your notice even more improvements in the coming months! I posted awhile ago that maybe a blood cleaning machine could be built that cleared out the alpha synuclein or whatever is producing Parkinson's. I hope this study gives more answers! Sure enjoy reading the posts Nan.

As you all know, I am participating in the Stanford Parkinson’s Plasma Study. There is so much interest in this that the researchers and I do not want to raise expectations unrealistically. This is a Phase I feasibility study, not anywhere close to ready for prime time. They have all the applicants needed and a full waiting list.
This is what they are doing: “The investigator proposes to test the safety and efficacy of transfusing young plasma into PD participants, in order to establish its effects on motor and cognitive functions in participants in a Phase 1 study. The successful completion of this study will inform the design of future, larger and multicenter studies with the goal to determine whether infusions of young plasma can ameliorate the neurodegenerative symptoms and underlying pathophysiology in Parkinson's disease.”
Realistically, this study will take a long time. They have to test and analyze the data, then write up their findings. Then, if warranted, they will move to a Phase II study, and then Phase III. So, whereas this is truly exciting, general applications for the public are not just around the corner. It’s not time to hold your breath. However, I will continue to provide updates.
Transfusions 3 and 4 went as before, only a little more efficient, which we all decided was appropriate since #3 was on Groundhog Day. Just like the movie, we do it over and over. Other than being exceedingly tired, probably from sitting still most of the day at the hospital and at airports, nothing seems different today so far.
Thanks for so much support.

Hi Nan,

It's good that you've put things in perspective and reminded us all that a (possible) new treatment based on young plasma is still years away.

It's understandable though that a lot of us are very excited to hear about the effects that young plasma may be having on you.

Another significant milestone will be the publication of the results of the (soon to be completed?) Alzheimer's plasma study.

Jeff

I think it will also be important for me to get as much information about my end of study tests as possible. My information to this point is obviously all anecdotal. I am also eager to see the results of the Alzheimer's study.

Thanks Nan for your updates.

Clearly, there is a lot more work to be done to show whether "young blood" therapy works. But, more and more I'm interested in how quickly a new therapy can get into common usage. Am I right in assuming that the "young blood" therapy is as low tech as it sounds and has no patents, so if it was found to be efficacious it could be delivered cheaply at your local hospital?

John

I'm sorry I don't have answers to your questions, but they would be the right ones to ask if the treatment proves to be efficacious. I think it would be sad if people started self-dosing before knowing answers to all the usual study questions. They are extremely cautious at Stanford, in a good way.

theguardian ** science 2015 aug 04 can-we-reverse-ageing-process-young-blood-older-people

an excellent article on young plasma.

More anecdotes. Transfusions five and six are in the books and I'm at the airport in Portland instead of in Seattle back in my own bed. Last night we flew from Reno to supposedly Seattle but we lost an engine and JH landed in Portland. The notable thing related to the study is that I felt no anxiety when normally I would be going through the ceiling under those circumstances. Other than getting no sleep last night, I'm feeling really pretty good. My muscles are loose, my neck is fully rotational, not cracking and I generally feel I'm just pretty healthy. Time to board the plane.

I'm at Stanford having my 7th infusion as I type. After two days of transfusions the rubber will meet the road as I go through the on and off tests Wed and Thurs like I did at the beginning of the study. Then, another month to wait for the last go round of tests. Other than still being very weary from spending a night in the airport last week, I feel amazingly fine.

I'm finished with my infusions at Stanford and have taken the first two batteries of tests that signal the end of the study for me. I take the last tests in mid-March and then wait for possibly two yeas to hear the results. As this is a Phase 1 study, there is a LOOOONG way to go. To facilitate communicating with many people, I wrote essays on my experiences, before and after the infusions, and posted them on my website: nanlittle.com. Please feel free to ask questions.

The last infusion was on Valentine's Day, how appropriate, and the interim report is that I continue to feel well, with very few of my PD symptoms in evidence. It's not that they are completely gone, just much reduced. How much of this is the placebo effect remains to be seen. Whatever it is, I'll take it.

I continue to feel really well now, almost three weeks after the last infusion. Oddly enough, II have developed some dyskinesia, which I didn't have before and my tremor has reappeared to some extent. I'm wondering if it's possible that I now have too much levadopa in my system, i.e., perhaps the infusions are changing my blood chemistry so that I am producing more levodopa on my own. I cut back one half of one 25/100 tablet and the dyskinesia eased up. Just a thought.

Nan,

I think you left out one (possibly important) piece of information. What happened with the tremor when you cut back the Sinemet?

Also, what exactly do you mean by "eased up"? Do you still have some dyskinesia?

If it was me, and I still had some dyskinesia, and the tremor hadn't gotten any worse, I would probably cut back a bit more.

Given your unique situation, we can expect that things will change again in the coming days and weeks, so you'll need to remain alert.

Jeff

Jeff, Your points are well taken. However, in order for the researchers to distill valid data, as many parameters as possible need to remain constant. For two days I experimented with the dosage and then decided my discomfort was less important than valid data so I went back to the Sinemet doses of 1 at 7, 10, 1 and 1/2 at 4 and 7.

The tremor only happens in a 10-15 minute time frame around pills at 4 and 7 p.m., and that's not always. That's generally true for the dyskinesia as well. When I was taking the full pill at 4 pm. the dyskinesia was very much in evidence. Now it is still there, but not nearly as noticeable.

Nan,

Thanks for the additional information. I think you've made the correct decisions.

Best wishes for the tests next week.

Jeff

Update. It has been 8 weeks since I started the Plasma study and four weeks since I had my last infusion. I expect it's possible that I'm experiencing the placebo effect, but I still have no nausea, etc. I'm weary in the late afternoons and I seldom get more than 6.5 hours of sleep, but I have energy for and interest in projects and the world around me. Dyskinesia and tremor have pretty well disappeared. Next week I return to Stanford for the final round of tests. So far, I'm a happy camper.

Check this out.

Old blood can be made young again and it might fight ageing | New Scientist

I think that this is extremely important for understanding PD and finding remedies for the multiple variations of the disease.
Researchers help map future of precision medicine in Parkinson's disease

Last Friday I finished my final testing for the Stanford Young Plasma Study, Phase I.

Although there were many tests, I have the numbers for the UPDRS. These numbers may reflect a placebo effect, but they are what they are.

I was tested both on and off medications in January before the first infusion; in mid-February after all eight infusions; and 5.5 weeks after the last infusion. Both on and off tests reflected a 50% drop in the UPDRS scores. The on medication test showed a continuing drop in score after the infusions were over, from 13 to 10 to 7. The off medication tests were 28, 14 and 14. As I have noted before, I feel very little effect from the Parkinson's since the infusions.

We also know that the forced pace cycling has made a tremendous difference in my disease progression. I'm wondering if the combination of the plasma and the cycling (and probably the placebo) is making a difference. At any rate, this appears to be going in the right direction.

All that said, we are talking about a sample of one, which is clearly more anecdotal than scientific. I'm eager too see what happens with the other participants in the study when the results are published in the next year or more.

I took part in another research study today, this one at the University of Washington. As part of the study I had UPDRS assessments both Off medication and On medication, the first such tests I've had since receiving the plasma infusions at Stanford in January and February. The section of the UPDRS that I have scores for is the Movement part, section 3. My Off medication score was three points lower than my initial Stanford assessment and my On medication score was three points higher than at Stanford. Of course the raters were different people and the scores are subjective, but I think we can safely say that my Parkinson's is closer to what it was before I started the infusions than when I ended them.

At first I felt sad. Then I took a closer look. I've had nearly 3 months of greatly reduced PD symptoms; the main annoying symptoms (nausea, constipation, anxiety, apathy, low energy, etc.) are still gone. I have a little dyskinesia and still have a really hard time in noisy spaces later in the evening, my sense of smell is disappearing again but still... none of us expected any positive outcomes to last beyond the actual infusions. What a fortunate woman I am!

APRIL 25, 2017 PARSING PARKINSON’S

Parkinson’s disease is characterized as a movement disorder identified by specific physical and cognitive characteristics. No biomarkers have been identified that determine whether or not a person has Parkinson’s. Often dementia-causing Lewy bodies are discovered in the brain at autopsy. Autopsy is not the most effective way to identify a disease.

After living with the PD diagnosis for nearly 10 years, I have a theory about Parkinson’s, and a suggestion about a research path to pursue. First, it is clear to me that Parkinson’s is a name for a group of diseases, much as “cancer “is the word that lumps multiple subsets of that disease. Cancer has breast, prostate, liver, pancreatic, skin, etc. etc., all forms of cancer with some common characteristics but differentiated by specifics and by treatment modalities. Similarly, the term “Parkinson’s” identifies a class of diseases, not a single entity that can be treated with one approach. It is no wonder that research trials consistently fail when they test a one size fits all application.

From my perspective, as one who lives with an iteration of the disease and who has many friends who live with various forms of it, I see manifestations as: tremor dominant and non-tremor dominant; early onset (before age 55) and normal onset (average age about 62); genetic and idiopathic, cognitively intact and cognitively challenged. Some people endure multiple physical challenges in walking, balance, bowel function, nausea, etc. Nearly everyone loses their sense of smell, ability to write normally and speed of movement and nearly everyone suffers from anxiety.

Treatments are all over the map. For over 50 years levodopa has been the gold standard drug. Deep Brain Stimulation (DBS) seems to be most effective for younger people with tremors. Dopamine Agonists, marijuana, “natural remedies”, and special diets each have their passionate followers. Exercise is the new medicine, especially high cadence cycling, but other exercises show promise as well and each has its following.

I think researchers will eventually catch on to the idea that one treatment won’t serve everyone, and the more they carry out large research studies without differentiating the PD population, the longer they are doomed to finding no single cause and no definitive cure or effective remediation of the diseases, because there IS no ONE disease; there are MANY.

This insight is the result of my very specific personal experience. Diagnosed in 2008, I learned about Forced Pace Cycling research done by neuroscientist Dr. Jay Alberts of the Cleveland Clinic. I signed up and by cycling far beyond his protocols, was able to effectively rid myself of the disease enough to enable me to ride my bike across Iowa six times, climb Mt. Kilimanjaro, and accomplish other unlikely feats for a woman in her late 60s. Despite my success with cycling, the disease continues its inexorable march through my body and mind.

In early 2017 I read about a Phase I study, the Stanford Parkinson’s Young Plasma Study, in which older PD patients would be infused with eight units of plasma taken from 18-25 year old males. This treatment idea was following up on research done with rats and Alzheimer’s patients that showed cognitive and motor improvements with such infusions. I immediately contacted the PI at Stanford and volunteered since my age, degree of deterioration, etc. fit the study parameters. At age 71 I became Patient #1, the first person in the world with Parkinson’s to undergo the young plasma treatment.

Phase I tests safety, not efficacy. However, the inevitable question on the table is whether or not this might work. Each week I flew back and forth to Stanford, receiving two infusions each trip. I had three extensive two day On and Off medication tests: before starting the infusions, at the end of the eight infusions and 5.5 weeks after the last infusion. My response was remarkable and unexpected. My UPDRS score in both On and Off testing was cut in half from the beginning to the 5.5 post-infusion week mark. Things that disappeared: dystonia, irritable bowel, constipation, gas, nausea, anxiety, weariness, apathy, need to nap. Things that returned: sense of smell, high energy, sleeping through the night, confidence. New things: dyskinesia (to a small extent), tremor (increased slightly). I wondered if the dyskinesia and tremor reflected too much dopamine in my system so, with the agreement of my doctor, I cut back my Sinemet from 4.5 tablets per day to 4.0. Both issues were somewhat, although not completely, resolved. Great!

What about the other people in the trial? There are to be 18 all together with testing ending by the end of 2017 and analysis finished by the end of 2018. In the meantime, I get no more plasma and no more testing to see how I’m doing. I keep records anyway and send them in to Stanford. One of the other women in the trial contacted me before she began the study. She has called me regularly to say how she’s doing and we actually met on my last visit to Palo Alto. Her report: nothing changed. How could that be?

Here’s where I go back to my original observation that there are many kinds of Parkinson’s that will call for various in treatments, and a further observation that treatments will most likely be effective when modalities are combined. The other patient doesn’t exercise and would not be considered fit. I exercise like a maniac. Dr. Alberts has shown that when people cycle as per his protocols, the same areas of the brain that are activated by medicine are activated by cycling. Cycling IS medicine. We know that medicine slows the progression of the disease but doesn’t stop it. Same for cycling. But WHAT IF?? WHAT IF?? medicine, cycling AND young blood infusions put us over the tipping point so that the disease is stopped, or even, as seems to be with my body, is reversed?

My last infusion was Valentine’s Day, 2017. More than two months later, despite some slipping, I’m still doing quite well. I feel I could do even better. The symptoms I got rid of slowly are sneaking back into the matrix. I’m told that Phase I will end in 2018, hopefully followed by Phases II and III and FDA approval. That will take at least 10 years, probably more. I’m 71. Do the math.

What would I like to see? There are over 30 Pedaling for Parkinson’s programs currently operating in the US, primarily at YMCAs, which could provide a prepared, eager resource of clinical trial participants who already take pill medicine and cycle medicine regularly. A new trial could reflect a subset of Parkinson’s patients whose inclusion criteria include medicine and cycling or other exercise that has a proven track record with PD patients. If it were successful, it would be a game changer in the world of Parkinson’s. If it weren’t successful, at least we would have some answers without waiting 10 years.